CODE OF CONDUCT FOR MEDICALLY ASSISTED REPRODUCTIVE TECHNIQUES

Ministry of Health, Sri Lanka 2024

Introduction
The primary aim of this document is to elevate the standards of Medically Assisted Reproductive
Techniques including Assisted Reproductive Technologies (ART) in Democratic Socialist Republic of Sri Lanka for streamlining the ART procedures.

Recognizing the profound public concern regarding the potential implications of new reproductive techniques on the perception and foundational values surrounding human life and familial relationships, the establishment of a Supervising Authority or “ART Authority” becomes imperative to address these ethical considerations.

The “ART Authority” is vested with responsibility of regulating ART services while offering
comprehensive guidance on the appropriate execution of all licensed activities.

This guidance should specifically include protocols governing the transfer of eggs, sperms and embryos between donors and recipients.
The Code of Practice integrates both mandatory provisions outlined in the proposed ART Act,
extensively referenced throughout the Code, and advisory measures delineating good practices.
Under the proposed ART Act, the Person Responsible would be obligated to consider all aspects of the Code.

Additionally, the “Licensing Committee”, in the execution of its authority, must duly
consider all pertinent sections of the Code.
PART 1: STAFF

Consultant in charge

Each institution should have a designated consultant responsible for overseeing the entirety of
clinical care provided and ensuring the safety and well-being of the patients throughout the
treatment process.
Mandatory requirement of the clinician in charge

1. Board Certified Consultant in Subfertility:
   a. Holds an MD in Obstetrics and Gynaecology from Postgraduate Institute of Medicine,
   University of Colombo.
   b. Holds certification or recognition as a Board-Certified Consultant in Subfertility in Sri
   Lanka. This certification acknowledges their expertise and specialization in managing
   subfertility issues and providing advanced reproductive medical care.
   Or
2. Board Certified Consultant in Obstetrics and Gynaecology with ART Expertise:
   a. Certified as a Consultant in Obstetrics and Gynaecology in Sri Lanka.
   b. Holds significant expertise and experience in the field of ART, demonstrating
   comprehensive knowledge and skill in providing ART-related services within the scope of
   Obstetrics and Gynaecology.
   Or
3. Foreign consultants who hold a temporary registration of the Sri Lanka Medical Council
   (SLMC) and are duly recognized and accepted as a Specialist in Subfertility by the SLMC.
   
   a. Registered and practicing as a consultant specifically in Subfertility in the country of
   origin Responsibilities
4. Medical assessment of the couple undergoing ART includes:
   a. Relevant medical history: Gathering comprehensive medical histories of both partners to
   assess any existing conditions, previous treatments, surgeries, or health issues pertinent
   to fertility.
   b. Physical assessment: Conducting a thorough physical examination to evaluate overall
   health and identify any physical factors that might affect fertility.
   c. Relevant fertility investigations and other medical and infectious screenings: Ordering
   and reviewing diagnostic tests and screenings to assess fertility status, potential
   underlying issues, and relevant infectious diseases.
   d. Counselling on fertility treatment options: Providing guidance and information on
   available fertility treatment options, including the consideration of donor gametes and
   embryos where necessary or advisable.
   e. Fertility counselling on procedure steps: Offering detailed counselling on various steps
   involved in the ART process, such as IVF stimulation, oocyte retrieval, embryo transfer,
   pregnancy testing, and subsequent follow-up procedures.
   f. Counselling on potential side effects: Educating the couple about possible side effects
   associated with IVF stimulation, oocyte retrieval procedures, and embryo transfer. This
   includes discussing risks like ovarian hyperstimulation syndrome (OHSS), multiple
   pregnancies, and ectopic pregnancies.
   g. Ensuring required consents and completed investigations: Ensuring that all necessary
   consents are obtained from the couple and that all required diagnostic investigations are
   completed before commencing ART procedures to mitigate risks and ensure compliance
   with legal and ethical standards.
5. IVF Stimulation:
   a. Planning the IVF stimulation protocol: Strategizing and designing the stimulation
   protocol tailored to the individual’s medical needs and optimizing the chances of
   successful follicular development and retrieval.
   b. Ensuring availability of required medication: Verifying and ensuring that all necessary
   medications for the stimulation protocol are available in adequate stocks at the
   treatment centre.
   
   b. Follicular tracking: Monitoring and tracking follicular growth and development through
   ultrasounds or other imaging techniques during the stimulation phase to assess the
   response to medications and adjust the protocol if needed.
   c. Identification and management of side effects: Being vigilant in identifying any side
   effects resulting from IVF stimulation and managing them appropriately. This includes
   being competent in detecting and managing all grades of Ovarian Hyperstimulation
   Syndrome (OHSS).
   d. Triggering: Administering the trigger medication (e.g., HCG – Human Chorionic
   Gonadotropin) to induce final egg maturation in preparation for egg retrieval at the
   appropriate timing within the treatment cycle.
6. Oocyte Retrieval (OR):
   a. Explaining the OR Procedure: Providing a detailed explanation to the patient about the
   OR procedure, including the steps involved, the anaesthesia or sedation used during the
   procedure, and what to expect before, during, and after the process.
   b. Explanation of possible side effects: Educating the patient about potential side effects or
   discomfort associated with the OR procedure, such as mild cramping, pelvic discomfort,
   bloating, and possible vaginal spotting or bleeding. It’s essential to provide information
   on how these side effects can be managed and what symptoms warrant immediate
   medical attention.
   c. Managing possible complications: Being prepared and equipped to manage any
   potential complications that might arise during or after the OR procedure. This includes
   promptly addressing issues like bleeding, infection, or any adverse reactions to
   anaesthesia or medications used during the process. Prompt and adequate medical
   attention is crucial to manage and mitigate complications effectively.
7. Embryo Transfer:
   a. Recommendation on the type of embryo transfer:
   i. Fresh Embryo Transfer: Recommending whether a fresh embryo transfer is
   suitable based on the treatment plan and individual circumstances.
   ii. Frozen Embryo Transfer (FET): Natural Cycle FET: Advising on FET within a natural menstrual cycle
   without
   additional hormonal medications. Medicated FET: Recommending FET within a hormonally controlled
   cycle. Modified Natural FET: Providing guidance on FET within a partially
   controlled cycle.
   b. Recommendation on Number of Embryos to be Transferred:
   i. Advocacy for Single Embryo Transfer: Strongly recommending single embryo
   transfer as the safest approach to minimize the risks associated with multiple
   pregnancies.
   
   ii. Limitation on Number of Embryos: Advising against the transfer of more than two
   embryos on a single occasion to reduce the likelihood of multiple gestations and
   associated complications.
   iii. Exceptional Circumstances for Consideration of Three Embryos: In specific
   exceptional cases, such as older women with a history of unsuccessful transfers or
   with suboptimal embryos deemed unsuitable for freezing and thawing, considering
   up to three embryos might be justifiable. However, meticulous records justifying
   such decisions should be maintained.
   c. Luteal Hormonal Support: Providing guidance and recommendations regarding hormonal
   support during the luteal phase following embryo transfer to optimize the chances of
   successful implantation and early pregnancy maintenance. This might include prescribing
   medications like progesterone to support the uterine lining.
8. Pregnancy Test and Follow-up in IVF:
   a. Pregnancy Testing:
   i. Timing of Pregnancy Testing: Advising the appropriate timing for the pregnancy
   test after the embryo transfer, typically around 10-14 days post-transfer.
   ii. Type of Pregnancy Test: Recommending the type of pregnancy test (blood test or
   urine test) based on clinic protocols and patient needs for accurate confirmation of
   pregnancy.
   b. Follow-up Care:
   i. Monitoring Early Pregnancy: Scheduling follow-up appointments or monitoring to
   assess early signs of pregnancy and ensure proper development.
   ii. Support and Guidance: Providing guidance and support to patients during the
   early stages of pregnancy, addressing concerns, and offering appropriate advice on
   diet, lifestyle, and medications.
   c. Continued Monitoring and Care:
   i. Continued Assessments: Planning and scheduling regular check-ups and
   assessments to monitor the progress of the pregnancy.
   ii. Addressing Complications or Concerns: Being available to address any
   complications or concerns that may arise during the course of the pregnancy,
   providing necessary medical interventions or referrals as required.
   d. Patient Education:
   i. Educating Patients: Providing comprehensive information to patients about what
   to expect during early pregnancy, common symptoms, warning signs that require
   immediate attention, and guidance on medications or lifestyle adjustments.
   Embryologist/Embryology team
   The Embryologist or the person in charge of an embryology laboratory is entrusted with full
   responsibility for the laboratory’s operations.
   Mandatory requirement
9. Degree in medical, veterinary, or biological sciences, coupled with a postgraduate degree
   specifically focused on Embryology. Additionally, registration within the “ART Authority”
   and/or Sri Lanka Medical Council as an embryologist is obligatory.
   
10. The individual should hold certified competence in embryology laboratory management
    and demonstrate a minimum of three years of practical experience in ART and related fields,
    which encompasses expertise in Andrology and proficiency in cryopreservation procedures.
    Successful completion of minimum of two years (24 months) of supervised training in both
    Andrology and embryology which should be endorsed and certified by a designated
    supervisor, enabling the clinical scientist to obtain registration with the “ART Authority” and
    /or Sri Lanka Medical Council as a clinical embryologist within a maximum duration of five
    years.
    Responsibilities
    The responsibilities of the Embryologist or Embryology team encompass a range of crucial tasks within the realm of ART, including:
11. Performing Conventional IVF: Overseeing and conducting the process of IVF by fertilizing
    retrieved eggs with sperm in a laboratory setting.
12. Performing Intracytoplasmic Sperm Injection (ICSI): Administering the specialized technique
    of ICSI, where a single sperm is injected directly into an egg to facilitate fertilization.
13. Egg Freezing: Managing the cryopreservation process of unfertilized eggs (oocytes) for
    potential future use.
14. Sperm Freezing: Preserving sperm samples through cryopreservation methods for future use
    in ART procedures.
15. Embryo Freezing: Handling and freezing viable embryos for storage and potential later use in
    Frozen Embryo Transfer (FET) procedures.
16. Biopsy for Preimplantation Genetic Testing (PGT): Conducting biopsies on embryos to collect
    cells for genetic testing before their transfer into the uterus.
17. Embryo Preparation for Fresh/Frozen Embryo Transfer: Preparing embryos for transfer in
    either fresh or frozen cycles, ensuring optimal conditions for successful implantation.”
18. Record keeping and maintaining statistics
19. Maintaining the optimal laboratory standards
    The person in charge of Andrology laboratory
    Mandatory requirement
20. Degree in medical, veterinary, or biological sciences coupled with a practical experience in
    Andrology and be registered within the “ART Authority” and/or the Sri Lanka Medical
    Council as a Clinical Andrologist.
21. Minimum of two years (24 months) of specific experience in Andrology laboratory
    procedures, quality standards, equipment handling, staff management, and overall
    laboratory management practices, thereby enabling them to competently lead and oversee
    operations within the laboratory
    
    Responsibilities of the Clinical Andrologist/ Andrology team
22. Laboratory Management: Taking charge of the day-to-day operations within the Andrology
    laboratory, ensuring adherence to quality control measures, maintaining equipment, and
    managing inventory and supplies.
23. Andrological Testing: Overseeing and conducting various andrological tests, including semen
    analysis, sperm morphology assessments, sperm viability tests, and sperm function tests,
    ensuring accuracy and reliability of results.
24. Semen Processing: Supervising procedures related to semen preparation for use in assisted
    reproduction techniques such as IUI and IVF/ICSI.
25. Cryopreservation: Managing the freezing and storage of sperm samples for future use,
    ensuring proper protocols are followed for successful cryopreservation.
26. Quality Assurance: Implementing and monitoring quality assurance and quality control
    measures to maintain high standards of laboratory procedures and accuracy of results.
27. Documentation and Record-keeping: Maintaining accurate records of test results, laboratory
    procedures, and patient information in compliance with regulatory standards.
28. Staff Training and Supervision: Providing training to laboratory staff, ensuring they adhere to
    standardized protocols, and overseeing their work to maintain quality and efficiency.
29. Compliance and Regulation: Ensuring the Andrology laboratory complies with all relevant
    regulations, guidelines, and ethical standards set forth by regulatory bodies.
    Medical Officers engaged in ART treatment services.
    Mandatory requirement
30. Full registration as medical practitioners with SLMC.
    Responsibilities
31. Conducting ART-related tasks, such as ultrasound scans, under the close supervision of the
    consultant in charge. Their work and decisions must align with the guidance and oversight
    provided by the overseeing consultant.
32. Do not bear the overall clinical responsibility for the patients undergoing ART procedures.
    The ultimate responsibility for clinical decisions and patient care lies with the consultant
    overseeing the ART treatments.
    Counselling Staff
    Mandatory requirement
33. Should hold a recognized qualification in counselling, clinical psychology, or psychotherapy
    at a diploma level or higher.
34. Counselling staff must demonstrate evidence of membership in a professional body relevant
    to their qualification.
    
    Responsibilities
35. Emotional Support and Counselling: Offering emotional support and counselling to
    individuals or couples navigating the complexities and challenges of fertility treatments. This
    includes addressing their concerns, fears, and emotional well-being throughout the ART
    process.
36. Assessment and Guidance: Conducting thorough assessments of the patients’ emotional and
    psychological state to understand their needs better.
37. Support in Decision-Making: Assisting individuals or couples in making difficult decisions,
    understanding the implications, and coping with the emotional stress associated with these
    choices.
38. Couples and Family Dynamics: Addressing issues related to relationships, communication,
    and family dynamics that may arise during fertility treatments, ensuring that both partners
    are equally supported.
39. Crisis Intervention: Offering crisis intervention and support in case of failed procedures,
    pregnancy loss, or any other emotionally distressing events during the ART journey.
40. Referral and Collaboration: Collaborating with other healthcare professionals or specialists
    when necessary and making referrals for additional support, such as mental health
    professionals or support groups, if needed.
41. Ethical and Legal Guidance: Providing guidance on the ethical and legal aspects of ART
    procedures, ensuring that patients are aware of their rights and responsibilities.
42. Documentation and Confidentiality: Maintaining accurate and confidential records of
    counselling sessions while adhering to ethical guidelines and ensuring patient confidentiality
    Nursing Staff
    Mandatory requirement
43. Registered with the Sri Lanka Nursing Council (for Nursing and Midwifery) or registered in Private Health Service Regulatory Council (PHSRC) as a Listed Nursing officer.
    Responsibilities
44. Patient Assessment and Care: Conducting initial assessments, monitoring patient progress
    throughout the ART cycle, and providing personalized nursing care tailored to the patient’s
    needs.
45. Medication Administration: Administering medications as prescribed by the healthcare
    team, including fertility medications, hormonal therapies, and medications for ovarian
    stimulation or preparation for procedures.
46. Procedure Assistance: Assisting in various ART procedures such as egg retrieval, embryo
    transfer, and IUI, ensuring proper preparation of patients and the environment for these
    procedures.
47. Patient Education: Providing comprehensive education to patients regarding their treatment
    protocols, medications, procedures, and post-procedure care to ensure patient compliance
    and understanding.
48. Monitoring and Documentation: Monitoring patients for any adverse reactions or
    complications, documenting observations, vital signs, and treatment administration
    accurately in medical records.
49. Emotional Support: Offering emotional support, guidance, and reassurance to patients and
    their families throughout the ART process, addressing concerns and providing empathetic
    care.
50. Collaboration and Coordination: Collaborating with other healthcare team members,
    including physicians, embryologists, counsellors, and administrative staff, to ensure seamless
    coordination of care and treatment protocols.
51. Adherence to Protocols and Safety Standards: Following established protocols, safety
    measures, and infection control practices to maintain a safe and sterile environment within
    the ART facility.
52. Post-Procedure Follow-up: Conducting follow-up assessments after procedures, providing
    post-procedure care instructions, and addressing any patient queries or concerns.
53. Patient Advocacy: Serving as advocates for patients, ensuring their rights, preferences, and
    concerns are addressed and respected throughout the ART process.
    Administrative Lead
    Administrative lead should have the minimum qualifications that are recognised by the government
    authority or relevant institutions
    Responsibilities:
54. Overall Responsibility for Centre Services: Ensuring that the centre operates efficiently
    and effectively.
55. Licensing and Approvals: Managing the process of obtaining necessary licenses, permits,
    and regulatory approvals required for the operation of the ART centre. This includes
    ensuring compliance with local regulations and guidelines.
56. Human Resource Management: Overseeing the recruitment, training, scheduling, and
    management of staff working in various roles within the centre. This involves
    maintaining staffing levels, addressing HR issues, and fostering a positive work
    environment.
57. Management of ART Equipment: Supervising the acquisition, maintenance, and
    management of specialized ART equipment necessary for various procedures such as
    IVF, ICSI, and embryo transfer. Ensuring the equipment is functional, calibrated, and
    meets quality standards.
58. Consumables and Supplies: Managing the inventory of consumables and supplies
    essential for ART procedures, including fertility medications, laboratory supplies,
    disposables, and other materials required for daily operations.
    10
59. Sterility Maintenance: Ensuring adherence to stringent sterilization and hygiene
    protocols within the centre to maintain aseptic conditions, critical for procedures
    involving gametes and embryos.
60. Compliance and Quality Assurance: Ensuring compliance with ethical, legal, and quality
    standards related to ART services. Implementing quality control measures, audits, and
    continuous improvement initiatives to maintain high standards of care.
61. Coordination and Collaboration: Facilitating communication and collaboration among
    different departments within the centre, promoting teamwork, and ensuring seamless
    coordination for efficient service delivery.
62. Patient and Stakeholder Relations: Maintaining positive relations with patients,
    stakeholders, regulatory bodies, and other external parties. Addressing patient
    concerns, ensuring satisfaction, and fostering a positive reputation for the centre.
    PART 2: ART CENTRE
    Facilities:
63. Theatre: Dedicated for procedures such as Oocyte Retrieval, Embryo Transfer, and other
    ART-related surgical procedures.
64. Recovery Area: Space allocated for post-procedure recovery and patient monitoring.
65. Embryology Laboratory: Specialized lab for handling and processing embryos and
    gametes.
66. Andrology Laboratory: Laboratory specifically equipped for assessing and handling male
    reproductive samples and procedures.
67. Sperm Sample Collection Area: Designated space for collecting and processing sperm
    samples.
68. Consultation Area: Rooms or areas for patient consultations and discussions.
69. Administrative Office: Space for administrative and managerial tasks.
    Staffing:
70. Qualified Specialists: Board-certified specialists in reproductive medicine or
    gynaecology/obstetrics with expertise in ART. (Refer Part A)
71. Embryologists: Trained professionals responsible for handling embryos and gametes in the
    laboratory. (Refer Part A)
72. Andrologist: Expertise in male reproductive health and responsible for andrology lab
    procedures. (Refer Part A)
73. Support Medical Officers: Medical officers providing medical support and assistance. (Refer
    Part A)
74. Nursing Staff: Nurses providing patient care, medication administration, and support. (Refer
    Part A)
75. Counselling Services: Qualified counselling staff offering emotional support and guidance to
    patients. (Refer Part A)
    11
    Services:
76. Patient Consultation: Offering initial consultations, discussions, and assessments related to
    fertility concerns and ART procedures.
77. Investigations: Conducting diagnostic tests and assessments to evaluate fertility issues.
78. Medication for ART Stimulation: Availability and administration of medications for ovarian
    stimulation.
79. Procedures: Facilities and expertise for Oocyte Retrieval, IVF/ICSI, Embryo/Gamete Freezing,
    and Embryo Transfer.
80. Counselling Services: Providing counselling and emotional support services to patients when
    needed.
    Confidentiality
    All individuals associated with the ART centre should strictly adhere to below mention
    confidentiality commitments to ensure the protection of patient information at all times.
81. Confidentiality of Activities and Patient Identities:
    a. All activities conducted within the licensed ART centre and the identities of patients should
    be treated with strict confidentiality.
    b. Maintaining the privacy of patients’ information, medical records, and any details related to their treatment procedures is imperative.
82. Written Undertaking for Confidentiality:
    a. All individuals employed or associated with the ART centre must provide a written
    undertaking to uphold and maintain strict confidentiality.
    b. This written commitment to confidentiality remains valid during their tenure at the centre
    and extends even after the period of service.
83. Commitment to Confidentiality: Employees, including medical professionals, administrative
    staff, nursing staff, counsellors, and any other personnel associated with the centre, should
    adhere to ethical standards and legal obligations regarding patient confidentiality.
84. Protection of Patient Information: Implementing measures to safeguard patient information
    from unauthorized access, disclosure, or misuse, ensuring that it remains secure and
    protected.
85. Ethical and Legal Compliance: Abiding by ethical guidelines, professional codes of conduct,
    and relevant laws regarding patient confidentiality and privacy rights.
    All individuals associated with the ART centre should adhere to these confidentiality
    commitments to ensure the protection of patient information at all times.
    Managing ART related Complications
    Ensuring the availability of emergency clinical facilities and preparedness to manage unforeseen
    situations such as surgical complications is crucial to safeguard patient safety and mitigate risks
    during ART procedures. This includes having the necessary resources, protocols, and trained
    personnel readily accessible to handle any emergency that may arise within the scope of assisted reproductive treatments.
86. Backup and Emergency Clinical Facilities:
    a. The ART centre should have adequate backup and emergency clinical facilities
    available for each technique practiced within the centre.
    b. These emergency facilities should be equivalent in standard to those commonly
    found in other medical specialties, considering the degree of risk associated with
    ART procedures.
87. Local Availability of Emergency Facilities:
    a. It’s mandatory that emergency facilities are readily accessible and available within
    the vicinity of the ART centre.
    b. These facilities should be capable of addressing and managing all foreseeable
    emergency situations that might arise during ART procedures or patient care.
88. Preparedness for Emergencies: The centre should have protocols in place for handling
    surgical emergencies related to ART procedures, ensuring prompt and effective responses to
    unforeseen events or complications.
89. Staff Training and Preparedness: Staff members should be adequately trained, prepared,
    and equipped to handle emergency situations that may occur during ART procedures or
    patient care.
90. Risk Mitigation Measures: Implementing measures to mitigate risks associated with ART
    procedures and ensuring that emergency facilities and resources are proportionate to the
    potential risks involved in these procedures.
    Privacy
    Ensuring comfort and privacy in ART centres is crucial to respecting the dignity and autonomy of individuals seeking fertility treatments or considering donation. Establishing an environment that upholds confidentiality and offers a supportive space contributes significantly to the overall wellbeing and experience of clients undergoing assisted reproductive treatments.
91. Comfort and Privacy for Patients:
    a. ART centres should prioritize the comfort and privacy of individuals seeking treatment,
    undergoing procedures, or considering donation within the facility.
    b. Creating an environment that respects and safeguards the privacy of patients is essential
    to ensure their emotional well-being and comfort during what can be a sensitive and
    personal journey.
    c. Facilities Acceptable to Clients:
    a. Taking reasonable steps to ensure that the facilities and settings within the ART
    centre are designed and organized to meet the privacy expectations of clients.
    b. Facilities should be arranged in a manner that provides private spaces for
    consultations, procedures, and discussions, ensuring confidentiality and comfort for
    individuals undergoing treatment or seeking services.
92. Respecting Individual Choices:
    a. Respecting the choices and preferences of individuals regarding privacy during
    consultations, procedures, or discussions related to fertility treatments or donations.
    b. Allowing individuals to have control over the disclosure of their personal information
    and ensuring that their confidentiality is maintained.
    
93. Confidentiality Measures: Implementing policies and procedures to maintain strict
    confidentiality regarding patient information, medical records, and any discussions or
    treatments within the ART centre.
94. Sensitive and Supportive Environment: Creating a supportive and empathetic environment
    within the centre, where individuals feel comfortable discussing their fertility concerns or
    undergoing treatments without fear of judgment or breach of privacy.
    In-Service Training
    Centres should arrange relevant training for all staff taking part in scientific, clinical, nursing or
    counselling activities for which the existing formal qualifications are not entirely sufficient.
    Providing in-service training opportunities is crucial for continuous professional development,
    ensuring staff members are well-prepared, competent, and capable of delivering optimal care and
    services in the dynamic and specialized field of assisted reproductive treatments.
95. Enhancing Skills beyond Formal Qualifications: In-service training is essential for staff
    members engaged in scientific, clinical, nursing, or counselling roles where formal
    qualifications might not entirely cover the specialized skills required in the field of
    assisted reproductive treatments.
96. Updating Knowledge and Techniques: Providing on-going training helps staff members
    stay updated with the latest advancements, techniques, and best practices in ART,
    ensuring they are equipped to provide high-quality care and services to patients.
97. Fostering Continuous Professional Development: In-service training programs facilitate
    continuous learning and professional development for staff, allowing them to expand
    their expertise, refine their skills, and adapt to changes in the field of reproductive
    medicine.
98. Addressing Specific Needs and Challenges: Tailoring training programs to address
    specific needs or challenges encountered in ART procedures, patient care, counselling,
    or laboratory practices within the centre.
99. Improving Patient Care and Safety: Well-trained staff are better equipped to provide
    efficient, safe, and effective care to patients undergoing fertility treatments, ensuring
    higher standards of patient safety and satisfaction.
100. Supporting Staff Confidence and Competence: In-service training boosts staff confidence
     and competence in performing their roles, which ultimately contributes to improved
     patient outcomes and experiences.
101. Compliance with Evolving Standards: Keeping staff informed and educated about
     evolving standards, guidelines, and regulatory requirements in ART practice, ensuring
     compliance with ethical, legal, and quality assurance standards.
     Clinical Facilities
     Laboratory Facilities and cryopreservation.
102. Good Laboratory Practice: Centres should adhere to Good Laboratory Practice standards,
     whether the laboratories are used for research or clinical services. This ensures adherence to
     quality standards, precision, and accuracy in all laboratory procedures.
     
103. Microbiological Hazards and Control of Substances Hazardous to Health (COSHH)
     Regulations: Awareness and compliance with COSHH regulations are essential, particularly in
     handling gametes and embryos, to minimize microbiological hazards and ensure a safe
     working environment.
104. Pre-testing of Blood Products: Blood products, other than those belonging to the patient
     undergoing treatment, that may come into contact with gametes or embryos should be pretested for HIV, hepatitis B, hepatitis C, and any other specified infections.
105. Proximity of Operating Theatre and Laboratory: The operating theatre used for egg retrieval
     in IVF procedures should be situated as close as practically possible to the laboratory where
     fertilization procedures, such as IVF or ICSI, are conducted. This proximity helps preserve the
     viability of collected gametes.
106. Dedicated Cryopreservation Facilities: Customized, secure, and dedicated cryopreservation
     facilities for gametes and embryos should be available within the ART centre. These facilities
     should match the volume and specific needs of the centre’s cryopreservation activities.
107. Emergency Procedures for Storage Systems: Implementation of appropriate emergency
     procedures to address failures or damages to storage vessels and systems used for
     cryopreservation. This ensures the safety and integrity of stored gametes and embryos.
108. Equipment Maintenance and Calibration: Regular maintenance, calibration, and validation of
     laboratory equipment used for ART procedures are crucial. Daily, monthly, and annual
     procedures for maintenance and calibration help ensure accurate and reliable results in
     laboratory processes.
     Freezing and thawing procedures.
     Adhering to below guidelines and procedures is crucial to maintaining the integrity, security, and
     ethical handling of frozen/thawed samples in ART centres, ultimately ensuring the safety and
     confidentiality of patients’ genetic material and contributing to the overall quality of assisted
     reproductive treatments.
109. Special Inventory System for Frozen/Thawed Samples: Implementing a specialized inventory
     system that records detailed information about frozen/thawed embryos or sperm. This
     includes identification/reference details, location, duration of storage, and specific
     information about the storage tanks holding each sample.
     
110. Secure Storage for Gametes and Embryos: Providing secure storage facilities for gametes
     and embryos where access is strictly controlled, ensuring that only authorized personnel
     have access to stored samples. This helps maintain confidentiality and security.
111. Handling of Contaminated Samples: Establishing protocols (Annex)for handling
     contaminated samples to minimize risks. Contaminated samples should be handled
     according to specific guidelines, with proper disposal procedures to prevent crosscontamination and potential risks to other samples or personnel.
112. Embryo/Sperm Disposal Procedures: Implementing proper procedures for the disposal of
     embryos or sperm that are no longer viable or required. This includes adherence to ethical
     guidelines and legal regulations for the disposal of biological materials, ensuring appropriate
     and respectful disposal.
113. The client should be informed about the procedure of discarding the embryos
114. Documentation and Record-Keeping: Maintaining meticulous records of all procedures
     related to freezing, thawing, storage, handling of samples, and disposal. Detailed
     documentation ensures traceability and accountability of each sample’s history and
     disposition.
115. Quality Control and Monitoring: Regular quality control checks, monitoring, and audits of
     storage conditions and inventory systems to ensure accuracy, reliability, and compliance
     with established protocols.
116. Staff Training and Protocols: Providing staff training on proper handling, storage, and
     disposal procedures for gametes and embryos. Ensuring that all personnel are familiar with
     protocols for maintaining sample integrity and safety.
     Counselling Centre/facilities
     Creating a dedicated and comfortable counselling environment within ART centres is crucial to ensure that individuals or couples receive the necessary information, support, and guidance to make informed decisions about their fertility treatments and reproductive choices.
117. Mandatory Counselling Opportunity: Individuals seeking licensed treatments like in vitro
     fertilization (IVF) or treatments involving donated gametes, as well as those consenting to
     the use or storage of embryos or donation/storage of gametes, should be offered suitable
     opportunities for proper counselling.
118. Private and Comfortable Counselling Rooms:
     a. Providing a dedicated, private, and comfortable room specifically designated for
     counselling purposes within the ART centre.
     b. Ensuring that the counselling room offers privacy and a tranquil environment, allowing
     individuals or couples to engage in discussions undisturbed.
119. Suitable Environment for Discussion: Creating a conducive environment where patients can
     openly discuss their concerns, queries, or decisions regarding fertility treatments, donation,
     or storage of reproductive material.
120. Trained Counselling Staff: Employing qualified and trained counselling staff who are skilled in
     providing emotional support, guidance, and information about the various aspects of
     assisted reproduction, including the emotional, ethical, and legal implications.
121. Respecting Confidentiality and Sensitivity: Upholding strict confidentiality and sensitivity
     during counselling sessions, ensuring that the information shared by patients remains
     private and that their emotional needs are respected and addressed.
     
122. Comprehensive Information and Support: Offering comprehensive information and support
     during counselling sessions, covering various aspects such as treatment options, procedures,
     potential risks, success rates, emotional implications, and legal aspects.
123. Respecting Patient Choices: Allowing individuals or couples the space and time to make
     informed decisions regarding their fertility treatments or decisions involving the use or
     storage of reproductive materials, without pressure or coercion.
     Reporting
     Having a robust reporting mechanism and monitoring system is crucial for ART centres to maintain
     transparency, identify areas for improvement, address issues promptly, and ensure the delivery of
     high-quality, ethical, and safe services to patients undergoing assisted reproductive treatments.
124. Annual Reporting to the ART Authority: ART centres are advised to submit comprehensive
     annual reports to the designated ART Authority. These reports should detail the centre’s
     activities, including the treatments provided, outcomes, any notable achievements, and
     serious problems encountered during the reporting period.
125. Immediate Reporting of Breaches or Serious Problems: In case of any breach of the Code of
     Practice or encountering serious problems within the centre, prompt reporting to the “ART
     Authority” (and PHSRC where relevant) is mandatory. Centres should inform the authority as
     soon as possible to address and rectify the issue.
126. Monitoring and Assessment Systems: Implementation of effective monitoring and
     assessment systems within the ART centre is essential. These systems should encompass
     laboratory, clinical, and counselling practices.
127. Ensuring Satisfactory Procedures and Outcomes: The monitoring and assessment systems
     should ensure that procedures and outcomes meet satisfactory standards set by
     professional colleagues.
128. Continuous Improvement and Quality Assurance: The monitoring system should facilitate
     continuous improvement, aiming for high-quality care and adherence to professional
     standards. This includes identifying areas for improvement and taking corrective actions
     when needed.
129. Transparency and Accountability: Maintaining transparency and accountability in reporting
     and addressing any concerns raised through the monitoring systems. It helps in maintaining
     public trust and confidence in the centre’s practices.
130. Compliance with Ethical and Professional Standards: Ensuring compliance with ethical, legal,
     and professional standards in the provision of ART services, reflecting a commitment to
     patient safety, quality care, and ethical practices.
131. The institution is bound and mandatory to report all twin, triplet and higher order multiple
     pregnancies to the designated ART authority/DGHS within the first trimester it self
132. The institution is bound to report all serious complications to its patients including OHSS and
     injuries during procedures to the designated ART authority/DGHS within 72 hours of the
     occurrence.
     Advertising
     Centres may wish to circulate information about the kinds of treatment that they provide. All
     publicity material should conform to the general principles in the guidelines of the “ART Authority”.
     
     ART centres must ensure that their advertising practices are responsible, ethical, and provide
     accurate information to individuals seeking fertility treatments, maintaining transparency and
     integrity in their communication with the public, in strict adherence to established following
     guidelines.
133. Dissemination of Information: must circulate information regarding the types of treatment
     they offer to raise awareness among the public about available services.
134. Conformity to “ART Authority” Guidelines: All advertising or publicity material disseminated
     by ART centres should adhere to the general principles outlined in the guidelines provided
     by the “ART Authority”.
135. Ethical and Accurate Information: Advertisements and promotional material should be
     ethical, accurate, and not misleading. They should provide factual information about the
     services, treatments, success rates (if mentioned), and available options without creating
     false expectations or promises.
136. Transparent and Clear Communication: Communication in advertising should be transparent
     and clear, avoiding any language or content that might create confusion or mislead
     individuals seeking fertility treatments.
137. Respect for Patient Dignity and Privacy: Respecting patient dignity and privacy in advertising
     practices by avoiding the use of identifiable patient information or any content that might
     compromise patient confidentiality.
138. Avoidance of Sensationalism or Unrealistic Claims: Avoiding sensationalism or exaggerated
     claims about success rates or treatment outcomes. Advertising should steer clear of making
     unrealistic promises that could mislead or exploit potential patients.
139. Compliance with Legal and Regulatory Standards: Ensuring compliance with legal and
     regulatory standards governing advertising practices in the healthcare sector, including
     guidelines set forth by the “ART Authority” and relevant governing bodies.
140. Professional Conduct and Accountability: Maintaining professional conduct and
     accountability in all advertising practices, reflecting the centre’s commitment to ethical
     healthcare provision and patient-cantered care.
     PART 3: ART cycle
     These guidelines aim to establish eligibility criteria for individuals seeking IVF treatment, ensuring responsible and ethical practices within ART centres in Sri Lanka.
141. Age Limitation for IVF Treatment: Females seeking IVF treatment should not exceed 50 years
     of age. This age restriction is in place considering the potential impact on maternal health
     and the well-being of the unborn child. This limitation aims to ensure the safety and health
     of both the mother and the child during and after pregnancy.
142. Legal Marriage Requirement for Sri Lankan Citizens:
     a. For citizens of Sri Lanka undergoing IVF treatment, it is mandatory that they are legally
     married.
     b. The ART centre should collect and maintain marriage certificates and identity documents
     of the couple seeking treatment. True copies of these documents should be included in
     the patient records as part of the verification process.
     c. Foreign citizens who are Legally Married or in a civil partnership can be offered IVF
     treatment
     18
143. The Body Mass Index (BMI) of the female partner should be within 18.5 and 35 for them to
     be eligible to be treated.
144. Wellbeing of the Unborn Child
     a. Clinician in charge should be satisfied about the ‘Wellbeing of the Unborn Child’
     before the commencement the IVF treatment.
     b. This is a mandatory requirement and should be recorded.
     c. If not satisfied (egg: Couple with Physical and/or Psychological and/ or social issues),
     the relevant stakeholders (e.g.: Medical professionals, Counsellors or any other
     relevant stakeholder) should be consulted in order to reach a conclusion on fitness
     of the couple to raise a child. These referrals and feedbacks should be
     comprehensively recorded.
     d. In the event the clinician is still unsatisfactory the ART authority should be consulted
     for opinion.
     Consents
     Ensure that both partners are well-informed and actively participate in decision-making throughout the ART procedures, maintaining transparency, and respecting individual choices and autonomy.
145. Consent for Stimulation: Informed written consent from both partners is necessary for
     ovarian stimulation, whether using their own gametes or donor gametes.
146. Consent for Oocyte Retrieval: Both partners must provide informed written consent
     specifically for the process of oocyte (egg) retrieval.
147. Consent for Fertilization (IVF/ICSI): Prior written consent is required from both partners for
     the fertilization process, whether through IVF or ICSI.
148. Consent for Embryo/Gamete Freezing and Storage Duration: Both partners need to provide
     consent for the freezing and storage of embryos or gametes. This consent should include the
     duration for which the storage is agreed upon.
149. Consent for Embryo Research: If applicable, explicit consent is required from both partners if
     embryos are to be used for research purposes.
150. Consent for Embryo Donation: In cases where embryo donation is involved, consent from
     both partners is mandatory for donating embryos.
151. Consent for Gamete Donation: If gamete donation is part of the treatment, both partners
     need to provide consent for the use of donated gametes.
152. Consent for Embryo Biopsy: If embryo biopsy is part of the procedure, explicit consent is
     required from both partners for this process.
153. Consent for Discarding Embryos: Both partners must consent to the discarding or disposal of
     embryos when necessary.
     Screening
     Screening tests and investigations are crucial in assessing the health status of the individuals
     involved and identifying any potential factors that might impact the success of ART procedures,
     ensuring better outcomes and minimizing risks during the treatment process.
154. Infections Screening: Mandatory screening for infections such as syphilis, hepatitis B and C,
     HIV, and other potential microorganisms to ensure the safety of the individuals undergoing
     ART procedures.
155. Immunological Investigations: Appropriate investigations should be conducted, especially
     when indicated, to exclude any immunological factors in the couple that might interfere with
     the success of ART procedures.
156. Karyotyping: Karyotyping, which involves examining an individual’s chromosomes, is
     recommended in specific situations:
     a. Family history of chromosomal disorders
     b. Recurrent pregnancy loss
     c. Recurrent implantation failures
     d. Persistent severe oligozoospermia (low sperm count), asthenozoospermia (poor sperm
     motility), or teratozoospermia (abnormal sperm morphology) in the male partner.
     Collection of Sperm
     The primary goal is to uphold suitable standards and transparency throughout the collection ndutilization of sperm for assisted reproduction procedures, accommodating exceptional situations,
     ensuring meticulous documentation, and adhering to ethical considerations as outlined below.
157. Production of Sperm in a Licensed Centre: Generally, it is preferable that sperm production
     for assisted reproduction procedures takes place within a licensed ART centre to ensure
     proper handling and quality control.
158. Exceptional Circumstances for External Sperm Production: In exceptional cases, when
     attempts at sperm production within the centre have failed, the centre may allow a man to
     produce sperm at home or elsewhere outside the centre. This should only occur under
     specific circumstances and following proper documentation of failed attempts within the
     centre.
159. Counselling and Declaration Requirement: In cases where sperm is produced outside the
     centre, counselling of both the husband and wife is essential. Both partners should submit a
     signed declaration confirming that the sample obtained from the husband is genuine and
     obtained under appropriate conditions.
160. Consideration for Embryo Donation: If embryos are created using partner sperm produced
     outside the licensed centre and there’s a consideration for donation of excess embryos, it is
     important to note and record that the sperm was not produced at a licensed centre. This
     information should be duly documented and taken into account if excess embryos are
     considered for donation.
     ART Stimulation
     This section outlines the consultant’s role in patient consultations, treatment planning,
     ensuring safety during ART stimulation, and handling potential complications like OHSS, ensuring
     high standards of care and patient safety throughout the IVF stimulation process.
161. Patient Consultation and Assessment: The consultant is responsible for conducting
     patient consultations and assessing both partners comprehensively through appropriate
     investigations.
162. Planning IVF Stimulation:
     a. Primary responsibility lies with the consultant in charge for planning IVF stimulation.
     b. Responsibilities include:
     
     ▪ Counselling the couple about the treatment plan.
     ▪ Providing guidance on the potential need for using donor eggs, sperm, or
     embryos if necessary.
     ▪ Counselling on the potential need for genetic assessment of embryos (PIGS), if
     available at the centre.
     ▪ Note: If PIGS facilities are unavailable, the responsibility falls on the Fertility
     Specialist to counsel the couple regarding PIGS and its advantages during the
     consultation.
163. Treatment Protocol and Management: The consultant decides on the treatment
     protocol, including determining the strength of stimulation, overseeing follicular
     tracking, and managing the triggering process.
164. Ensuring Patient Safety during Stimulation: Ensuring patient safety is paramount; the
     consultant is accountable for providing adequate IVF stimulation without compromising
     patient safety.
165. Management of Ovarian Hyperstimulation Syndrome (OHSS):
     a. The consultant should possess competence in managing OHSS should it occur during
     the stimulation process.
     b. Reporting severe or critical OHSS cases to the supervising authority within 24 hours
     is mandatory.
     Oocyte retrieval
     Delineate the roles and responsibilities of medical professionals involved in Oocyte Retrieval,
     ensuring proper patient care, documentation, and handling of retrieved oocytes for further ART procedures.
166. Performing Oocyte Retrieval: Oocyte retrieval should ideally be performed by a Consultant
     in Subfertility. If not available, a competent Consultant Gynaecologist with Expertise in ART
     should conduct the procedure.
167. Patient Consent and Explanation: The procedure and possible complications should be
     thoroughly explained to the patient by the Consultant, before starting the Oocyte Retrieval,
     and informed written consent should be obtained.
168. Documentation and Reporting: Notes regarding the Oocyte Retrieval should be documented
     by the performing Consultant in Subfertility or a competent VOG. These notes should be
     signed and dated.
169. Anaesthesia and Sedation: A consultant anaesthetist should provide adequate anaesthesia
     or sedation during the procedure and is responsible for relevant documentation related to
     this aspect.
170. Post-Retrieval Responsibilities: After the procedure, the consultant who performed the
     Oocyte Retrieval is responsible for informing the patient about the number of oocytes
     retrieved and any complications encountered during the process.
171. Responsibility of the Embryology Team: The embryology team is responsible for handling the
     retrieved oocytes, performing procedures like IVF/ICSI, monitoring embryo growth, and
     overseeing embryo freezing processes.
172. Embryology team is responsible for storing the frozen embryos and gametes maintaining the
     traceability of origin.
173. Quality Assurance and Facility Maintenance: The embryology team is also accountable for
     ensuring that the facilities for embryo freezing meet the required standards. They should
     
     take necessary steps to maintain these standards and promptly inform the clinical and
     administrative teams if any issues arise.
     Fertilization
     This section underscores the importance of a well-justified and medically appropriate selection of
     fertilization procedures in assisted reproduction, ensuring the best possible outcomes for patients
     while considering their individual fertility profiles and medical conditions.
174. Justifiable Reasons for Fertilization Procedures: The choice between different fertilization
     procedures (e.g., Conventional IVF, ICSI, or other advanced technologies) should be based on
     justifiable and medically sound reasons.
175. Individualized Selection: The decision-making process for selecting a specific fertilization
     method should consider individual patient factors, the couple’s fertility history, and any
     underlying medical conditions that may impact the success of the procedure.
176. Medical Necessity and Optimal Outcome: The chosen fertilization method should aim to
     maximize the chances of successful fertilization and subsequent embryo development,
     taking into account the unique circumstances and needs of each individual or couple
     undergoing assisted reproduction.
177. Expert Evaluation and Recommendations: Fertility specialists or reproductive medicine
     consultants should conduct a thorough evaluation and provide expert recommendations,
     ensuring that the chosen fertilization procedure is appropriate and aligns with the patient’s
     specific needs and circumstances.
     Donor eggs/Sperms/Embryos
     Aiming to regulate and ensure the responsible usage of donor sperm in assisted reproduction,
     considering both the health aspects and confidentiality of the donor, as well as establishing limits to prevent excessive offspring from a single donor.
     All donors of Embryos, oocytes and Sperms should be registered at the ART Authority.
     All ART centres should have a separate register on donors Embryos, oocytes and Sperms and submitted to the ART Authority to maintain a Master registry of all types of donors.
     All donors should be comprehensively assessed and investigated by a qualified Clinician before registering as a donor. (Significant Medical or Genetic conditions and Infectious screening)
     All centres should promptly inform the ART authority before performing a donor cycle from a
     particular donor to ensure that the respective donor treatment cycle falls within the ART Authority guidelines.
     Similarly, all centres performing donor treatments should promptly inform the ART Authority about the outcome of the donor treatment cycle. (e.g.: Positive Pregnancy test, Live Birth)
     All centres should promptly inform the ART Authority if a donor treatment cycle results in foetal anomalies/ congenital anomalies in such instances the suitability of the donor should be reassessed.
     
     Until such time samples from the respective donor/donors should be withheld. The samples from the investigated donor can be used for treatment cycles only after clearance by ART Authority.
     Donor Sperms
178. Limitation on number of Donations: Donors providing sperm can father a maximum of 10
     children through sperm donation cycles and thereafter should be taken off from the
     Registry. This limit aims to prevent excessive proliferation of offspring from a single donor
     and mitigate potential genetic relationships between half-siblings.
179. Routine Screening for STIs: Donors must undergo routine screening for sexually transmitted
     infections (STIs) such as HIV 1 and 2, Hepatitis B and C, and syphilis. These tests should show negative results within the last three months before donation.
180. Disclosure of Blood Group: The blood group of the sperm donor should be disclosed to the
     recipient and adequately explained.
181. Confidentiality of Donor Identity: The identity of the sperm donor must be maintained with
     strict confidentiality. It should never be disclosed to the recipients unless mandated by legal
     provisions.
182. Age Criteria for Donors: The recommended age for sperm donors is between 20 and 45
     years. However, in exceptional circumstances where a suitable young donor is not available,
     an older person may be considered for sperm donation, after careful assessment and
     relevant Implication Counselling ensuring careful evaluation and assessment.
183. Absence of Significant Medical and Inherited Illnesses: Sperm donors should not have any
     known significant medical conditions or inherited illnesses that could pose potential risks or
     complications to the recipient or the offspring
     Donor eggs
184. Limitation on number of Donations: Donors providing Oocytes can mother a maximum of 10
     children through Oocyte donation cycles and thereafter should be taken off from the
     Registry. This limit aims to prevent excessive proliferation of offspring from a single donor
     and mitigate potential genetic relationships between half-siblings.
185. Minimum Gap Between Donation Cycles: There should be a minimum gap of six months
     between consecutive egg donation cycles by a single donor. This time frame allows for
     sufficient recovery and reduces potential risks associated with multiple donations.
186. Routine Screening for Infections: Donors must undergo routine screening for infectious
     diseases such as HIV 1 and 2, syphilis, Hepatitis B, and C. These tests should indicate
     negative results within the last three months before donation.
187. Confidentiality of Donor Identity: The identity of the egg donor should be strictly confidential
     and not disclosed to the recipients unless required by legal provisions.
     Other Criteria of eligibility
     Additional criteria aim to ensure the suitability and health of egg donors, considering factors such as age, previous reproductive history, and absence of significant medical or inherited conditions, thus contributing to safer and more successful assisted reproduction procedures.
188. Age Range: Ideal age range for egg donors is generally less than 35 years and above 20 years old. However, under exceptional circumstances where a suitable young donor is not
     available, consideration may be given to older individuals.
     
189. Preferable to Have a Living Child: It is preferable for an egg donor to have at least one living
     child of her own. This criterion may vary based on individual clinic policies and preferences.
190. Absence of Significant Medical and Inherited Illnesses: Egg donors should not have any
     known significant medical conditions or inherited illnesses that could pose potential risks or
     complications to the recipient or the offspring.
     Egg Sharing
     Egg sharing arrangements in assisted reproduction, allowing women to donate eggs while
     undergoing IVF treatment themselves, maintaining confidentiality, and ensuring that recipients cover the associated costs for the donor’s IVF treatment up to the egg retrieval stage.
191. Age Criteria: Women participating in egg sharing programs should generally be below 35
     years old.
192. Childbearing Status: Egg donors in sharing programs may be women with or without living
     children.
193. Simultaneous IVF Treatment: Women participating in egg sharing programs might undergo
     IVF treatment simultaneously, allowing them to donate eggs while receiving IVF treatment
     themselves.
194. Confidentiality of Donor/Recipient Identities: The identities of both the egg donor and
     recipient should be kept strictly confidential. Disclosure to recipients should only occur when
     mandated by legal provisions.
195. Financial Responsibility: Recipients participating in egg sharing should cover the costs of the
     IVF treatment for the donor, up to the point of egg retrieval.
     Donor Embryos
     Aiming to regulate the usage of donor embryos in assisted reproduction, emphasizing the necessity of consent from biological parents, ensuring no financial gains for the centre from recipients, and maintaining traceability of embryos for accountability and proper record-keeping.
196. Consent of Biological Parents: Obtaining the consent of the biological parents of the embryo
     is mandatory before utilizing donor embryos. This consent should be documented and
     recorded.
197. Financial Transactions The centre should not derive any financial benefit from the recipient
     for providing surplus donor embryos. This practice ensures that the usage of embryos is not
     driven by financial gain for the centre.
198. Traceability of Embryos: All surplus or frozen embryos used in assisted reproduction
     procedures should be traceable back to their biological parents or to the target couple. This
     traceability ensures accountability and proper records regarding the origin and usage of
     embryos.
     Sex Selection of Embryos
     Aiming to restrict the use of sex selection in assisted reproduction to only medically justified
     reasons, ensuring that the practice is employed solely for addressing specific genetic or medical concerns rather than for non-medical or social preferences.
199. Prohibition of Social Reasons: Treatment centres should refrain from selecting the sex of
     embryos for non-medical or social reasons. This means that sex selection solely for family
     balancing or personal preferences unrelated to medical concerns is not permissible.
200. Medical Justification for Sex Selection: Sex selection of embryos may be offered only when
     there are specific medical reasons. These could include cases where there is a risk of
     inheriting genetic disorders that are linked to a particular sex chromosome (e.g., Y
     chromosome linked genetic disorders, X-linked dominant diseases).
     Embryo Transfer
     Regulate and standardize the procedures and circumstances surrounding embryo transfer in assisted reproduction, ensuring appropriate techniques, cycle choices, and ethical considerations during the transfer process.
201. Performing Embryo Transfer: Embryo transfer should ideally be performed by a consultant in
     subfertility or a Consultant Gynaecologist (VOG) with Expertise in ART. Types of Transfers: Embryo transfer can be conducted as either a fresh embryo transfer or a
     frozen embryo transfer (FET). Options for Frozen Embryo Transfer (FET): Frozen embryo transfer (FET) can occur in different cycles: natural cycle, modified natural cycle, or medicated cycle.
202. Recommendation for Medicated FET: Medicated FET is recommended for patients with
     conditions such as Endometriosis or Adenomyosis, or in cases where menstrual cycles are
     highly irregular.
203. Avoidance of Mixing Gametes or Embryos: Women should not be treated with gametes or
     embryos derived from the gametes of more than one man or one woman during any
     treatment cycle. This includes practices like embryo mixing or sperm mixing.
     Number of Embryos Will regulate the number of embryos transferred during assisted reproduction, emphasizing the preference for single embryo transfer to mitigate the risks associated with multiple pregnancies, while considering individual patient factors and history of previous treatments.
204. Factors Influencing Number of Embryos: The decision on the number of embryos to transfer
     should consider the patient’s age, embryo quality, and outcomes of previous embryo
     transfers.
205. Preference for Single Embryo Transfer (SET): Single embryo transfer (SET) is considered the
     optimal choice as it minimizes the risks associated with multiple pregnancies while
     maintaining the chance of a successful pregnancy.
206. Limitation on Number of Embryos: Transfer of more than two embryos is generally not
     recommended due to the higher likelihood of multiple pregnancies.
207. Rare Consideration for Triple Embryo Transfer: In exceptional cases, a clinician may consider
     a triple embryo transfer for older patients with poor-quality embryos and a history of
     multiple unsuccessful Frozen Embryo Transfers (FETs). This decision is rare and made under
     specific circumstances.
208. Prevention of Multiple Pregnancies: It is crucial to minimize the risk of multiple pregnancies
     by using the minimum number of embryos necessary for a successful pregnancy.
209. Reporting and Investigation of Higher Order Pregnancies: Any triplet or higher-order
     pregnancies resulting from assisted reproduction should be reported to the relevant
     authority. Investigation by the authority is necessary to provide recommendations or
     appropriate actions.
     Transfer of Gametes and Embryos
     Transfer of gametes and embryos between licensed treatment centres must be done in accordance with the directions made by the Authority.
     This will ensure that the transfer of gametes and embryos between licensed treatment centres in assisted reproduction follows strict directives laid down by the supervising authority, maintaining regulatory compliance and standardized procedures to safeguard the integrity and safety of these biological materials during transportation.
210. Compliance with Authority’s Directions: The transfer of gametes (sperm or eggs) and
     embryos between licensed treatment centres should strictly adhere to the directions
     provided by the supervising or regulatory authority overseeing assisted reproduction
     practices.
211. Regulatory Compliance: Any movement or transfer of gametes or embryos between centres
     must comply with the specific guidelines, regulations, and protocols set forth by the
     governing regulatory body responsible for overseeing assisted reproductive treatments.
     Disposal of Embryos
     Ensure that the decision-making process and procedure for the disposal of embryos in assisted reproduction are handled sensitively, ethically, and in accordance with established guidelines, promoting transparency and proper communication with the involved parties.
212. Decision-making for Disposal: In cases where an embryo is no longer required for treatment
     or storage, the treatment centre is responsible for determining the method and procedure
     for allowing the embryo to perish.
213. Sensitive Procedure Development: The procedure for disposal should be sensitively
     developed and clearly described by the centre. It should take into account ethical
     considerations and be communicated to the individuals or parties for whom the embryo was
     originally being stored.
214. Reference to SLMC Code of Practice: The disposal process should align with the guidelines
     and directives outlined in the SLMC Code of Practice, ensuring adherence to ethical
     standards and proper protocols for handling perished embryos.
     Embryo Research
     This ensures that any embryo research conducted in the field of assisted reproduction is subject to rigorous oversight and ethical considerations, requiring explicit approval from the regulatory authority and its Ethics Committee while referencing established guidelines related to embryo donation.
215. Need for Authority Approval: Embryo research is only permitted upon receiving explicit
     approval from the ART Authority overseeing assisted reproduction, along with the
     involvement and consideration of its Ethics Committee.
216. Decision-Making Process: The ART Authority, with inputs from its Ethics Committee, will
     evaluate and consider all relevant details before granting approval for any proposed embryo
     research activities.
     
217. Reference to Embryo Donation Guidelines: Specific guidelines or procedures for obtaining
     embryos for research purposes should align with the section dedicated to embryo donation.
     This section likely contains further details on the process of acquiring embryos for research
     purposes.
     Gestational Surrogacy
     Gestational surrogacy is only utilized/allowed for medical reasons, and the legal ownership of the baby follows a defined procedure, acknowledging the birth mother’s initial ownership while allowing for subsequent transfer to the biological parents through legal procedures.
218. Medical Indication: Gestational surrogacy should be permitted only in cases where there are
     clear medical indications necessitating the use of a surrogate mother for pregnancy.
219. Ownership of Baby: The mother who physically delivers the baby through gestational
     surrogacy is considered the rightful owner of the child initially. However, legal procedures in
     the country allow for the transfer of ownership to the biological parents post-delivery.

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