DRAFT: CONSULTATIVE DOCUMENT ON ETHICAL GUIDELINES ON BIOMEDICAL RESEARCH INVOLVING HUMAN SUBJECTS
( By Indian Council of Medical Research New Delhi )

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Assisted Reproductive Technologies

I. TECHNICAL AND SCIENTIFIC ASPECTS/font>

1. INTRODUCTION

The special programme by WHO on human reproduction has estimated that there are 60 to 80 million infertile couples worldwide. It has also been variously estimated that between 6 - 10% of the couple are infertile. In India, the stable family structure and the desire for children is the norm; there is also a social stigma associated with infertility. As a result of these two there is an ever increasing demand for dignostic and therapeutic interventions in infertile couple. The advent of technologies of Assisted Reproduction have not only enhanced the possibility of pregnancy but have also made women conceive in situations which would have not have been possible a decade ago.However many of these technologies require enormous technical expertise and infrastructure, carry a success rate below 30% even in the best of hands, are expensive, and tax the couple's endurance physically, emotionally and economically. There is an urgent need to draw up necessary guidelines, so that optimum benefit of these newer technologies are made available to appropriate persons by skilled team of experts, at affordable health and economic cost, at identified facilities for Assisted Reproductive Technology in our country.


2. HISTORICAL PERSPECTIVE


The first report of successful extracorporeal fertilization and cleavage of the human egg is that of Rock and Menkin in 1944. Thirty years later the successful extracorporel fertilisation and cleavage of a donor egg and transfer into a recepient uterus was reported. It was only in 1978 that the first "test-tube baby" was born due to the efforts of Edwards and Steptoe. An earlier attempt had resulted in an ectopic pregnancy. In 1979 Schettles reported the intratubal transfer of freshly aspirated oocytes at the time of tubal anastomosis. This had been preceded the following day by cervical insemination. The patient delivered normally at term. In 1983 Tesarik reported the first pregnancy after tubal microsurgery and transfer of oocyte and sperm into the fallopian tube in the same sitting. Asch and workers reported a pregnancy and birth following laparoscopic placement of sperm-oocyte mixture in 1984. Devroey reported the first pregnancy and birth by the technique of Zygote Intrafallopian Transfer in 1986. With increased success rates of ovarian stimulation, oocyte retrieval and invitro fertilization and development, the problem of dealing with excess oocytes and embryos has been tackled effectively by cryopreservation. Trounson reported the first human pregnancy following thawing of frozen embryos in 1983. Cryopreservation is also of use in cases of oocyte donation. Micromanipulation of gametes has been utilised for those situations with severe male factor, in the presence of previous failed fertilization and in the presence of antibodies impeding sperm-oocyte interaction. The first pregnancy was reported by this technique in 1988.



3. OBJECTIVE OF THE DOCUMENT


The objective of this document is to standardise and regularise the use of these technologies in our country. Since these technologies are aimed at alleviating the problems of the infertile couple, proper use of this technology is vital.


4. DEFINITION AND SCOPE


Assisted Reproduction is defined as "manipulating the oocyte outside the body and then transfer of gametes or embryos again into the body". The technology covers the following procedures :



  • In vitro fertilisation and embryo transfer (IVF-ET)
  • Gamete Intrafalloppian transfer (GIFT)
  • Zygote intrafalloppian Transfer (ZIFT)/Preembryo Transfer/Pronuclear Stage Embryo Transfer (PROST)
  • Transfer of gamate/embryo and surrogate motherhood.
  • Micromanipulation of gametes

Although strictly speaking only the above categories fit the description of Assisted Reproductive Technologies, other allied techniques are also to be considered because these are often used as a part of management of infertile couples before they are considered for ART. These allied techniques include :



  • Intrauterine insemination
  • Sperm Intrafallopian Transfer
  • Sperm Intraovarian Transfer
  • Intraperitoneal Sperm Transfer

5. SCREENING OF INFERTILE COUPLE


In India most couples marry young. As and when a couple anxious to conceive seek medical help, a simple examination of both the husband and wife should be done irrespective of preceding period of infertility. If menstrual history, sexual history, physical examination findings of the couple and semen analysis report are normal the couple may be reassured, counselled and requested to report back if there is no conception within 2 years of cohabitation ( if the age of woman is more than thirty years, then take the period as 1 year of cohabitation. This advise is given mainly to avoid unneccessary investigations and invasive procedures.


Detailed investigations without waiting any further and if required, referral to centres carrying out IVF could be carried out immediately under the following conditions:



  • wife is healthy and is more than 35 years of age
  • severe endometriosis
  • genital tuberculosis
  • irreparable damage to or absence of Fallopian tubes
  • frozen pelvis
  • absence of ovary
  • primary ovarian failure - azoospermia, severe oligo, asthe no or teratozoospermia, in the husband
  • absense of uterus

Preliminary investigations and management for infertile couple can readily be carried out at District Hospitals, Urban Clinics, Medical Colleges and appropriately equipped Private Clinics. The following minimal investigations need to be carried out to ascertain the cause of infertility.


Husband: (In 40% of infertile couples male factor is a cause of infertility)



  • Physical examination both systemic and local to detect any problem that might be the cause of infertility or modify the management of infertility.
  • Semen analysis including both morphological and functional tests should be carried out ; if any abnormality detected repeat tests may be done after suitable intervals. Abnormal finding on repeated semen examination warrants full scale investigation by appropriate specialist to ascertain the cause and institute necessary treatment.
  • Screening for infections including Syphilis, Hepatitis B and HIV and appropriate management.
  • If needed appropriate endocrinological investigations and therapy.

Wife :



  • Physical examination both systemic and local to detect any problem that might be the cause of infertility or modify the management of infertility.
  • Detection and timing of ovulation by BBT, cervical mucus study, ultrasonography, premenstrual endometrial biopsy and histopathological examination.
  • Assessment of tubal patency by appropriate investigations including Hysterosalpingography, Diagnostic ultrasound, laparoscopy or hysteroscopy if required to find out/ rule out specific problems and to assess response to therapy.
  • Screening for local factors including cervical mucus related problems and lower genital tract infections and instituting appropriate therapy.
  • Screening for reproductive tract infections including Syphilis, Chlamydia, Tuberculosis, Hepatitis B and HIV and appropriate management.
  • If needed appropriate endocrinological investigations and therapy.

Preliminary screening and management of infertile couple are to be carried out at hospitals/clinics where trained and interested Gynaecologists/Andrologists/Endocrinologists and investigation facilities are available. Once the cause of infertility had been identified, simple management procedure can be taken up by trained Gynaecologist/Andrologist. First line management with appropriate therapy including ovulation induction with or without artificial insemination using husband's semen (repeated atleast upto 6 cycles) should be attempted in such centers and only those couples who are not responding, may then be referred to AR Centres.


6. SELECTION CRITERIA FOR ART


i) Selection Criteria for In Vitro Fertilization and Embryo Transfer (IVF-ET) :



  1. Tubal Disease
  2. Emdometriosis
  3. Unexplained infertility
  4. Immunological factors
  5. Cervical factor
  6. Male factor
  7. Ovarian disorders
  8. Uterine disorders
  9. In association with donor eggs and donor embryos

1. Tubal Disease


I.V.F./E.T. can be offered where microsurgical techniques for tubal and peritoneal disease have failed or are unlikely to benefit the patient. The choice between I.V.F. and Microsurgery would be dictated by the presence of peritubal adhesions, condition of the tubal wall, condition of the ciliary epithelium and degree of fimbrial damage. Patients who have already undergone tuboplasty and those with inaccessible ovaries would be more suitable for I.V.F. In cases of history of ectopic pregnancy, I.V.F. would be a better option.


2. Endometriosis


I.V.F. is a suitable option for women with moderate to severe endometriosis and in those where medical and surgical therapy have failed and sometimes is even offered for mild to moderate endometriosis in the presence of other factors contributing to infertility.


3. Unexplained infertility


Couples who have prolonged unexplained infertility would benefit from I.V.F. as many factors such as subtle ovulation defects, defects in ovum pick-up, gamete transport, tubal environment, sperm abnormality, oocyte abnormality may come to light when I.V.F. is used.


4. Immunological factor


I.V.F. can be considered when there are antisperm antibodies in the male or the famale and when other techniques such as immunosuppression, use of condoms, intrauterine insemination and other therapeutic measures have failed.


5. Cervical factor


I.V.F. can be offered for cervical factor only if repeated attempts (6 to 8 cycles) of intrauterine insemination have failed and other therapies have not resulted in pregnancy.


6. Male factor


I.V.F.-E.T. is logical therapy in the presence of low concentrations of sperm (less than 10 million/ml.), low motility (less than 30%) and in the presence of abnormal morphology (greater than 60% of abnormal forms as per Yovich). In severe male factor, assisted fertilization by means of Micromanipulation and sperm injection can be offered even in obstructive and non-obstructive cases. No universally accepted minimal sperm concentration for IVF success exists. In severe oligospermia,teratospermia, cryptospermia, azoospermia (obstructive/nonobstructive) intracytoplasmic sperm injection can be employed using either ejaculated or epididiymal sperm.


7. Ovarian disorders


I.V.F. - E.T. can benefit patients with hypogonadotropic anovulation, oligoovulation, and luteal phase deficiency, although IVF is rarely indicated when these disorders exist as isolated conditions. IVF - ET can be used for women with luteinized unruptured follicle syndrome in polycystic ovarian disease.


8. Uterine disorders


Patients with mullerian agenesis, congenital uterine anomalies, and women with severe intrauterine adhesions refractory to surgical lysis of the adhesions as well as hysterectomized patients can, through IVF, transfer their embryos to a surrogate mother.


9. In association with donor eggs and donor embryos


Women who have undergone either premature menopause or timely menopause and women in the perimenopausal age group who do not show proper recruitment of follicles and who have other existing causes of infertility can avail of the option of donor eggs and donor embryos. Also women with genetic disorders, those who have undergone radiation therapy and with ovaries which are not accessible by ultrasound due to severe adhesions can avail of donor eggs.


ii) Selection Criteria for Gamete Intrafallopian Transfer(GIFT):



The experimental background for gamete intrafallopian transfer is the ability of the fallopian tube to serve as the site for capacitation and fertilization in human beings. Earlier experiments by GIFT were carried out on monkeys who had undergone tubal resection and ligation. In 1979 Shettles reported pregnancy after intratubal transfer of freshly aspirated oocytes at the time of tubal reanastomosis combined with cervical insemination. Asch and colleagues reported the first pregnancy and birth using laparoscopic GIFT. Indications are almost similar to that of IVF-ET.


iii) Choosing between IVF - ET & GIFT



Deciding on which technique to utilise must be individualised for each patient. The advantages of IVF over GIFT are documentation of fertilization, less trauma and anaesthetic risk. There is no exposure to excess quantities of carbon dioxide in IVF as happens during laparoscopic insufflation with GIFT. It has been suggested that GIFT is more natural as fertilisation occurs in the tubal ampulla, the gametes are minimally exposed in vitro and early embryo development occurs in a natural environment.


iv) Zygote Intra Fallopian Transfer (ZIFT)



This is an offshoot of the IVF and GIFT procedures where the first pregnancy was reported by Devroey. This procedure entails the transfer of preembryos into the falloppian tube either laparoscopically or by transvaginal retrograde cannulation of the fallopian tubes either by ultrasound or by hysteroscopic guidance.


v) Microassisted Fertilisation



Subzonal insemination (SUZI), Intracytoplasmic Sperm injection (ICSI) and Assisted hatching need micromanupulation of gametes. SUZI involves sperm injection directly into the oocyte outside the body, this is replaced by ICSI which involves injection of sperm into the cytoplasm of the oocyte under certain conditions such as aging ova, in elderly women, repeated failure of implantation at IVF and in male factor infertility. Assisted hatching of embryo by drilling a hole in the zona pelucuda is resorted prior to embryo transfer for improving implantation rates.

Finally, the choice of the procedure used eg. IVF-ET, GIFT, ZIFT, PROST etc. is made depending upon the needs of the couple, availability of facilities, experience and expertise of the gynaecologist/embryologist.


7. COMPLICATIONS


AR procedures carry a small risk both to the mother and the offspring . It is essential that these risks are defined and explained to the couple and appropriate counsellng done. AR procedures are to be initiated only after they understand these and still want to undergo AR. Some of the most commonly encountered problems include :


1. Multiple Gestation



The reported incidence of multiple gestation range from 20- 30 %. Incidence of twin in the range of 10- 20 % may have to be accepted as inevitable but specific efforts are to be made to reduce the incidence of triplets and multple births of higher order. Most of the AR practitioners do not tranfer more than three oocytes for GIFT and more than three embryos for IVF-ET at one sitting ; the remaining embryos, if any, are cryopreserved and if required tranferred at a later cycle.


2. Ectopic Pregnancies



Ectopic pregnancy rates range from 0 to 8% for AR procedures; choice of apppropriate procedure especially in persons with tubal disease may reduce the ectopic pregnancy rates.


3. Spontaneous Abortions



Spontaneous abortion rates range from 20 to 35%. Abortion rates rise with increasing age of the mother and in multiple pregnancies especially presence of three or more foetuses.In cases where more than three foetuses are present many AR experts advise selective embryo reduction.It is essential that the advantages of embryo reduction (better chances of the survival of the other foetuses and the fact that they are likely to be born nearer term, with better birth weight) and disadvantages (the possibility that there might be an increased risk of abortion following the procedure) have to be explained to the couple and then informed consent taken before embryo reduction is attempted.


4. Preterm Births



There is a higher risk of premature/ low birth weight delivery following AR especially in the presence of multiple foetuses.


5. Ovarian Hyperstimulation Syndrome



The use of superovulation for Assisted Reproductive Technology entails the risk of Hyperstimulation for some women (0.2 -8.0%). This is determined by the hormonal profile of the woman, the Estradial values (greater than 2000- pg./ml.), the dose for the trigger of ovulation, the ability to aspirate all the follicles at the time of oocyte retrieval and a host of other factors. The Programme Director should be fully aware of the means of avoiding hyperstimulation and also of treating it. Careful monitoring and management will reduce the risk of this, as well as the morbidity associated with hyperstimulation.

In addition to these specific complications of AR, the persons undergoing various AR procedures incur the risks associated with the operative and anaesthestic procedures involved in AR.


8. FACILITIES


Assisted Reproduction requires the availability of



  1. Manpower with expertise and qualifications.
  2. Infrastructure such as Equipment/Supplies/Space.

i) Manpower - Expertise and qualifications The organisation and implementation of an ART programme calls for significant teamwork with close collaboration, coordination and cooperation between concerned and commited clinicians, endocrinologists, ultrasonographists, embryologists and a team of supportive paramedical and laboratory workers. All members of the team should have a commitment to the programme which often calls for irregular working hours and hard work. It is essential that right from the inception of the programme there is clear cut documentation on the responsibilities of each of the team members. The following personnel form an ideal team.

a) Clinical Director (Clinical Science) : The Director is the Team Leader and is overall incharge of the clinical as well as the laboratory aspects of Assisted Reproduction Technology. He or she could be a gynaecologist with adequate training in endoscopy, oocyte retrieval, administration and laboratory and would be required to liaison with the clinical faculty, laboratory faculty, secretary, nurse, anaesthetists, RIA laboratory, psychiatrist and operating room staff. The director should be competent to tackle any emergency arising from clinical situations and in the laboratory. He should be fully aware of use of hazardous material eg. liquid nitrogen. The Director has the following major responsibilities :



  • obtaining informed consent for all procedures,
  • selection of patients for various Assisted Reproduction procedures,
  • the decision to repeat/ change over to other methods/advise termination of further attempts at AR procedures,
  • to tackle any emergency arising from clinical situations and in the laboratory,
  • maintanance of records and ensuring confidentiality,
  • periodic analysis of data and review of the activities and appropriate corrective measures as and when necessary,
  • laison with the state/central govt agencies,
  • submission of appropriate data e.g. the pregnancy rates to the Accreditation authority or licensing authority or Registry.

b) Laboratory Director (Basic Science) : Post-graduate in reproductive biology with adequate training and experience in the Andrology and Embryology laboratory, quality control, media preparation, semen examination and cryopreservation. His administrative duties would include purchase of equipment and supplies, hiring of laboratory personnel and formulate all laboratory policies. His qualifications would be a M.Sc., preferably a Ph.D. and M.D. desirable.

c) Technologists (Lab) : Laboratory personnel trained in media preparation and quality control, serum collection and preparation, maintenance of equipment and supplies, maintenance of log books, performance of quality control, and ability to identify oocytes, fertilization and cleavage (sperm-egg interaction) and semen analysis and preparation procedures. They should be Science graduates with the above skills and also have basic understanding of cultural conditions. The laboratory staff should have adequate protection from blood products and semen. All couples entering the IVF programme should be pre-tested for HIV and Hepatitis-B in order to protect the laboratory personnel.

d) Nurse Coordinator : A qualified Nurse with experience in Gynaecology and Infertility fields. She would be responsible for daily blood collection, obtaining endocrine assay reports, maintenance of equipment in the operation theatre, scheduling of appointments and sonography examinations and assisting in oocyte retrieval and embryo transfer.

e) Counsellor : The role of the counsellor is well acknowledged in the treatment of infertility as clinical research suggests that the infertile couple is at risk for sexual dysfunction, psychiatric co-morbidity and marital conflict. Psychological evaluation and intervention should be offered to couples and should be available on request. The counsellar should be a person with thorough understanding of ART procedures and benefits and problems associated with them. He should be able to give a clear picture about the centre, services offered, cost and present pregnancy rate.

In developed countries specially trained counsellors are usually available and counselling is taken as an essential pre-requisite for couple seeking ART. In the Indian context especially in smaller centres which have just been opened, specific trained counsellor may not be readily available; in such a situation, the Gynaecologist, Andrologist and Embryologist or the Para medical personnel who had the know- ledge, time, skill, and interest in counselling can be entrusted with the task of counselling the couple. It is essential that every effort should be made to explain the procedures that are going to be used and their consequences to the couple, assess their response and needs before ART procedures are initiated.

f) Secretary : The secretary would be responsible for patient appointments, answering inquiries and letters and administrative duties.

g) Ancillary Services : These would include



  • Anaesthetist,
  • Radio immunoassay Laboratory and
  • Technical staff in the Operation theatre and Laboratory.

The entire programme of ART stresses on the importance of team effort. The individuals have to work dynamically in groups. Professional burnout can occur in this highly and intensely personal technololgy and hence the leader or director of the group has responsibility and privilage of holding the group together.

ii) Equipments , Supplies and Space


a) Space :


The space requirements for isolation of Embryology, Andrology Laboratories and Operation Theatre should be met. These areas should be supplied by clean, filtered, air-conditioned air. Ideally speaking the laboratory should be under a positive pressure environment and should be walled off from other areas. Other rooms would include Interview rooms, Examination room, Sonography room, Recovery room, Patient waiting area, Toilet areas, Waste collection areas, Autoclave room and Semen collection room. The walls in the Operation Theatre and the Laboratory should be easily washable and disinfected. Carpeting is not permitted. Aerosols and pest control should not be used in the Laboratory.


b) Equipments :


The following equipments are mandatory for ART Programme :



  1. Horizontal laminar flow hood.
  2. Stereo microscope.
  3. Inverted microscope.
  4. Phase contrast microscope.
  5. Water jacketed CO2 incubator with CO2 regulator and at least 3 CO2 cylinders.
  6. Osmometer.
  7. pH meter.
  8. Centrifuge and ultracentrifuge.
  9. Water bath.
  10. Analytical balance.
  11. Refrigerator.
  12. Millipore water purification system.
  13. Stage warmer.
  14. A Makler Chamber for semen analysis or haematocytometer.

To set up ART lab, cryogenic unit and micromanupulation equipments are desirable.


c) Supplies :





  1. Semen containers.
  2. Tissue culture flasks.
  3. Disposable pipettes.
  4. Culture tubes and Embryo transfer catheters.
  5. Oocyte retrieval needles and tubes.
  6. Culture dishes.
  7. Organ culture dishes.
  8. Ultrapore filters.
  9. Microscope slides and cover slips.
  10. Rubber bulbs.
  11. pH buffer.
  12. Osmometer fluid.
  13. Pipette tips.
  14. Disposable syringes (Liverlock), 1ml, 2ml, 5ml, disposable needles.
  15. Cryopreservation vials and straws.
  16. Spirit lamp.
  17. Cartridges for water purification system.
  18. Tissue culture medium and chemicals associated with preparation of tissue culture media.

Note - All material used in the ART Laboratory should not be toxic to sperm and embryo.



 


9. COORDINATION, COLLABORATION AND COOPERATION


Assisted Repropductive technology is highly specialised and needs financial, technical and clinical backup. After setting up the facility, its smooth functioning calls for proper liason, understanding and trouble shooting alongwith coordination and cooperation from all areas.

In many metropolitan cities of India the expertise and facilities needed are available in different institutions situated a few kilometers apart and they may be able to work together even though they are all not working under the same roof in the same institution.

The Institutions where the experts from different specialities work, have all the necessary expensive sophisticated equipments. In the existing situation of economic constraints it might be worthwhile to set up AR clinics in an area where an operation theatre and embryology laboratory are present in the close proximity in the same institution. The infrastructure available in the neigbouring institutions can be utilised optimally for diagnositc procedures needed for AR. This may be the most efficient and cost effective manner in which ART programme may be initiated in India. This arrangement however requires personal commitment of the individuals concerned and the commitment from the respective Institutions that the facilities will be made available on a continuous basis to the couple seeking AR. In such situation, the In-charge shall be Co-ordinator of the Institute, (Director or Dean or person designated as Head)


10. ESTABLISHMENT OF PROTOCOLS AND MAINTENANCE OF RECORDS


All protocols used in the laboratory for I.V.F. and related procedures must be documented and available as manuals. These manuals should be revised periodically. Log books for the maintenance and periodic overhauling of all equipment should be maintained. The entire procedure from the ovarian stimulation protocol to the oocyte retrieval and oocyte and sperm preparation including evaluation of the morpholgy of the gametes, their number, timing of insemination, date of embryo transfer, number of embryos or gametes transfered and the fate of the gametes must be documented. Abnormal pre-embryos such as polyploid embryos should not be transfered. Cryopreserved material must be labelled indexed and stored properly. The laboratory personnel should be well-versed with the techniques of cryopreservation. Batches of culture media must be identified. All agents used in the Laboratory must be entered in a Register and the date of receipt of the reagents entered on the box containing the reagents. Asepsis should be maintained at all times. Each couple undergoing treatment should have a minimal screen for HIV and Hepatitis. Sera of patients used for embryo culture should not be interchanged. The Laboratory personnel should be offered vaccinations for Hepatitis B. Gloves should be worn at all times. Clothes specific for use in the laboratory should be provided. Regular shoes should not be taken into the Laboratory. Preparation of culture media should be done in dedicated containers using ultrapure water and dedicated reagents. The media should be checked for pH and osmolarity. Facilities for proper refrigeration and freezing should be available, back-up of electrical supply and voltage stabilisers should be available in areas prone to electrical failures.

Mouth pipetting is not permissible and only mechanical pipetting is allowed. Eating, drinking, smoking within the precints of the Laboratory should be prohibited. Contaminated material should be disposed off in the proper fashion. Biological material should be handled with care and disposed off after sealing.

It is essential that all documentation regarding every patient treated in the centre is maintained meticulously and all precautions are taken to ensure that confidentiality is maintained. It is preferable that a networking of the centres involved in ART Programmes are attempted right now when only a few centres are doing ART, so that as more and more centres take up the programme the net work will grow and the Regional and National data on the ART programme will automatically become available.


11. ACCREDITATION


It is estimated that at the moment there are about 50 centres offering AR in India. Some have been well established and have been functioning for some years. Others are in various stages of being established.

In order to ensure quality of care it is imperative that a proper accreditation procedure is followed in establishement of AR centres. All AR centres should follow standardised protocols and guidelines. There should be a strict internal and external quality control programme for all AR centres. A team consisting of gynaecologists, embryologists, andrologists, legal and ethical experts along with the social scientists may be included in the accreditation committee.Representatives of various professional bodies in the specialities connected with AR procedures such as the Federation of Obstetric and Gynaecological Societies of India (FOGSI) and Indian Society for Assisted Reproduction (ISAR) may also be included in the accreditation committee. In addition the opinion of these professional bodies and organisations such as Indian Council of Medical Research (ICMR) and Drug Controller of India (DCI) should be saught on the recommendations of the accreditation committee.


The aim of the accreditation procedure is to ensure that :



  • the institutions providing AR do maintain the quality of care expected
  • infertile couple get good quality care and are not exploited
  • the institutions offering AR do get the needed support especially in terms of streamlined procedures for import of needed drugs, reagents and equipment.

Appropriate expert panel would inspect the AR centres as a part of accreditation procedure before the centre is operationalised and also periodically after it starts functioning. The accreditation committee will review the existing infrastructure and facilities, the track record of the centre, the upkeep of the records, security arrangements for gamete, embryo storage and maintanance of the confidentiality and make their recommendations to the appropriate authorities. Appropriate legal/executive procedures for providing accreditation to these centres will have to be evolved and implementing agencies identified. AR Centres require ready access to reagents, drugs and equipment many of which have to be imported in order to provide patient care. Steps may have to be evolved to assist accreditted ART centres by streamlining the procedures that these centres have to adapt for import, so that their requirements are met without undue delay and additional expenses.

Some of the accreditted centres can be utilised for training postgraduates or interested specialists from the related specialities so that in a phased manner AR facility becomes more widely available in the country. Some of the accreditted ART centres could also take up research studies on specific aspects of AR based on approved protocols.


12. REGISTRY


A national registry pertaining to all centres who are accredited by the licensing authority should be maintained and should contain records of treatment cycles and outcome.


II. ETHICAL AND LEGAL ASPECTS OF ASSISTED REPRODUCTIVE TECHNOLOGIES


1. GENERAL ETHICAL AND LEGAL ASPECTS



There is a certain element of risk associated with AR procedures. It is therefore necessary to ascertain the therapeutic value of the AR procedure in each case.


1.1 Informed Consent



After duly counselling the couple/oocyte/semen donor, an informed and written consent should be taken from both the spouses as well as the oocyte donor, as the case may be. They should be explained the various risk factors associated with the procedures in simple language and the words that they can understand. These include risks associated with ovarian hyperstimulation, anaesthestic procedures, invasive procedures like laparoscopy, aspiration of ovum. They should also be explained the possibility of multiple pregnancies, ectopic gestation, increased rate of spontaneous abortion, premature births, higher perinatal and infant mortality as well as growth and developmental problems.


1.2 Selection of Donor



The doctor assumes the responsibility in selection of the suitable donor in terms of following:



  • Complete physical examination of the donor should bedone to ascertain the good health of the donors of semen, oocyte or embryo.
  • The donor should be healthy with a good quality eggs or sperms and preferably with proven fertility record.
  • The physical characteristic and mental make-up of the donor should match as closely as possible to that of the spouse of the recipient, specially with reference to colour of the skin, eyes and hair, height and build, religious and ethnic background, the educational level and ABO blood type.
  • Blood group of the proposed donor and donee should be tested with respect to Rh compatibility.
  • No person suffering from any sexually transmitted disease (e.g. syphilis, gonorrhea, chlamydia, herpes, HIV etc.), infectious disease (e.g. hepatitis - B, HIV) or genetically transmissible disease should be used as donor.
  • Sexually transmitted diseases should be ruled out not more than one week before the seminal fluid is obtained. It is preferable that donated semen is cryo-preserved and used only after 6 months as this would enable the centre to retest the donor after 3 months for HIV and eliminate the potential risk of HIV transmission in the 'window' period of HIV infection.
  • Identity of the donor as well as the recipient should be protected from each other. However all the records of the donor must be preserved in order to trace him/her in case of any eventuality and should be confidential.
  • Confidentiality of the entire procedure and its outcome is advisable and therefore no relative should be accepted as a sperm donor besides avoiding the claims of parenthood and inheritance rights.
  • Written consent of the donor should be taken towards unrestricted use of sperms or oocytes for AR, as well as an undertaking from him/her that he/she will not attempt to seek the identity of the recipient. In case of the donor is married, to take the written consent of the spouse, if possible.
  • It is also desirable to restrict the use of semen from the same donor to 10 pregnancies to avoid the possibil ity of an incestuous relationship occurring among the offsprings at a later date.
  • In case of the oocyte donor, incurring any health problems during the process of donation, the costs of the subsequent health care should be borne by the potential recipient couple irrespective of whether they receive oocyte donation as planned or not.
  • In case of unused surplus embryos, consent of the concerned couple should be obtained to cryopreserve such embryos for donation to other needy couples. Such embryo donations should be kept anonymous.

2. SPECIFIC ETHICAL AND LEGAL ISSUES INVOLVED IN ART


2.1 Legitimacy of the Child born through ART



A child born through AR is presumed to be the legitimate child of the couple having been born within the wedlock and with consent of both the spouses with all the attendant rights of parentage, support and inheritance. Sperm/oocyte donor should have no parental right or duties in relation to the child and their anonymity should be protected.


2.2 IVF-ET and Surrogate Motherhood



There are no medicolegal problems posed by IVF-ET with egg and sperm of married couple. With either egg or sperm donated, it is governed on the same lines as AID with the married partner being the natural or biological mother. IVF-ET with donated egg or sperm or womb leasing will create two to three sets of parents, genetic, biological and natural. Following consensus has emerged universally with respect to surrogate motherhood:



  1. Surrogate motherhood should be legal only when it is coupled with authorized adoption.
  2. It should be rebuttably presumed that a woman who carries the child and gives birth to it is its mother.
  3. The intending parents should have a preferential right to adopt the child subject to six week's postpartum delay for necessary maternal consent.
  4. It should be legal only if medically certified as the only solution to infertility or any other medical bar on pregnancy, by the intending mother.
  5. It should be supervised by a qualified consultant to enforce adequate genetic screening.
  6. The contract for surrogacy despite reasonable payment of compensation on completion of adoption would be validsubject to surrogate's right to retain the baby if she so desires. The only remedy for the genetic father then would be to claim for custody on the grounds of the best interest of the child.
  7. Abortion under the Abortion Law on the medical ground should be an inviolate right of the surrogate and the adopting parents have no claim over the amounts already paid.

2.3 Adultery in case of AID



AID in a married woman with the consent of the husband does not amount to adultery on part of the wife or the donor, as there is no sexual intercourse involved. AID without the husband's consent can be ground for divorce or judicial separation.


2.4 Consummation of Marriage in case of AIH



Conception of the wife through AIH does not necessarily amount to consummation of marriage and a decree of nullity would still be granted in favour of the wife on the ground of impotency of the husband or his willful refusal to consummate the marriage. However, such a decree could be excluded on the grounds of approbation.


2.5 Rights of An Unmarried Woman to AID



There is no legal bar on an unmarried woman going for AID. However, universally it is recommended that AID should be performed only on married women and that too with the written consent of her husband, two parent family being always better for the child whose interests will always outweigh all other interests. Besides, child born to a single woman through AID is deemed to be illegitimate.


2.6 Posthumous AIH through Sperm Bank



Though the Indian Evidence Act, 1872 says that a child born within 280 days after dissolution of marriage (by death or divorce) is a legitimate child since that is considered to be the gestation period, it is pertinent to note that this Act was enacted as far back as 1872 when one could not even visualise ART. The law needs to take note of these advancements. A child born to a single woman is already not in a very happy position, in our society specially; why doubly damn him by branding him as illegitimate? Considered opinion is that a child born to a woman with the sperms of her deceased husband artificially inseminated should be considered to be a legitimate child notwithstanding the existing law of presumptions under our Evidence Act. The law needs to move alongwith medical advancements and suitably amended so that it does not give rise to dilemnic or harsh situations.


2.7 Preservation, Utilisation and Destruction of Embryos



While passing The Human Fertilisation and Embryology Act 1990, the British Parliament accepted the Warnock Committee recommendations prohibiting research on or keeping alive any live embryo over 14 days after fertilisation, excluding the period during which the embryo was frozen with maximum storage period of 10 years and a 5 yearly review of semen and embryos deposits. Under this law, early this month nearly 3000 frozen embryos were destroyed in the UK after the expiry of 5 year statutory limit and no consent coming forth from the parents to extend the limit by further 5 years.

In a case of dispute arising between the couple since divorced, after the preservation of embryos, over the right of the woman to conceive the child and seeking custody of the embryos, a recent judgement has gone in favour of the woman, the husband having consented to the conception at the time of fertilisation. However, the child born in such a case would be deemed to be an illegitimate child.


Resource Material



  • - Guidelines for Human Embryology and Andrology Laboratories. Fertility & Sterility.October 1992, Supplement 1, vol.58, No.4 (1S & 11S).
  • - Guidelines for Gamete Donation. Fertility & Sterility February, 1993, vol.59, No.2 (1S & 5S).
  • - Human Fertilisation and Embryology Authority : Code of Ethics, London, 1993.
  • - Ontario Law Reform Commission's Report on Human Artificial Reproduction - Related Matters of Canada.
  • - American Fertility Society's Ethics Committee Report "Ethical Considerations of the New Reproductive Technologies" 1986 and 87.

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