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Journal of the Academy of Hospital Administration

Statement of Specific Principles for Assisted Reproductive Technologies

Author(s): Editor

Vol. 15, No. 2 (2003-07 - 2003-12)

Key Messages:

  • This is the last and concluding part of the ongoing series, which deal with specific principles for Assisted Reproductive Technology.
    Editor

Introduction

The special programme by WHO on human reproduction has estimated that here are 60 to 80 million infertile couples worldwide. It has also been variously estimated that between 6-10% of the couple are infertile. The advent of Assisted Reproductive Technologies (ART) have not only enhanced the possibility of pregnancy but have also made women conceive in situations which would not have been possible 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. In order to ensure quality of care it is imperative that a proper accreditation procedure is followed in establishment of ART Centres, which should follow standardize protocols and guidelines. A national registry pertaining to all centers that are accredited by the licensing authority should be maintained and should contain records of treatment cycles and outcome.

Definition

Assisted Reproduction is defined as "manipulating the gametes outside the body and the transfer of gametes or embryos into the body".

All protocols used in the laboratory for Assisted Reproduction (AR) procedures must be documented and available as manuals. These manuals should be revised periodically. Log books for the maintenance and periodic overhauling of all equipments should be maintained. The entire procedure from the ovarian stimulation protocol to the oocyte retrieval and oocyte and sperm preparation including evaluation of the morphology of the gametes, their number, timing of insemination, date of embryo transfer, number of embryos or gametes transferred and the fate of the gametes must be documented. Abnormal pre-embryos such as polyploid embryos should not be transferred. Cryopreserved material must be labeled 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 their receipt entered on the box containing them. Asepsis should be maintained at all const. Each couple undergoing treatment should undergo a minimal screening for HIV and Hepatitis. The laboratory personnel should be adequately protected which include screening and vaccinations.

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.

General Principles

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

Informed Consent:

After duly counseling the couple / ocolyte/semen donor, an informed and written consent should be taken from both the spouses as well as the 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, and invasive procedures like laparoscopy, aspiration of ovum etc. They should also be explained the possibility of multiple pregnancies, entopic gestation, increased rate of spontaneous abortion, premature births, higher perinatal and infant mortality as well as growth and developmental problems. They should also be explained that there is no guarantee on the success / failure of the procedure.

Selection of Donor:

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

  • Complete physical examination of the donor should be done to ascertain the good health of the donors of semen, oocyte or embryo.
  • The donor should be healthy with reasonable expectation of 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 within a week of obtaining the seminal fluid.
  • It is essential that donated semen is cryo-preserved and used only after 6 months as this would enable the centre to retest the donor after 6 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 donor in order to avoid identification and 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 the donor is married, the written consent of the spouse should be taken, if possible.
  • It is also desirable to restrict the use of semen from the same donor to a maximum of 10 pregnancies to avoid the possibility of an incestuous relationship occurring among the offspring at a later date.
  • In case of the oocyte donor, incurring any health problems related to the process of donation, the costs of the subsequent health care should be borne by potential recipient couple irrespective of whether they receive oocyte donation as planned or not.
  • In case of unused surplus / spare 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. The ownership rights of such embryos rest with the couple concerned.

Specific Principles

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 the spouses with all the attendant rights of parentage, supports and inheritance. Sperm/oocyte donor should have no parental right or duties in relation to the child and their anonymity should be protected.

IVF-ET (in-vitro fertilization and embryo-transfer) and Surrogate Motherhood: There are no medico-legal problems posed by IVF-ET with egg and sperm of married couple. Donation of either egg or sperm is governed on the same lines as those for Artificial Insemination Donor with the married partner as the natural or biological mother. IVF-ET with donated egg or sperm or womb leasing will created two to three sets of parents, genetic, biological and natural. The following consensus has emerged universally with respect to surrogate motherhood:

  1. It should be resorted to only when it is coupled with authorized adoption wherever applicable.
  2. It should be rebuttably presumed that a woman who carries the child and gives birth to 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 resorted to only if medically certified as the only solution to infertility or any other medical bar on pregnancy, by the intending mother.
  5. A qualified consultant should supervise to enforce adequate genetic screening.
  6. The contract for surrogacy despite reasonable payment of compensation on completion of adoption would be valid subject to surrogate's right to retain the baby if she so desires.
  7. The only remedy for the genetic parent would be to claim for custody on the grounds of the best interest of the child.
  8. Abortion under the Abortion Law on the medical ground should be inviolate right of the surrogate and the adopting parents have no claim over the amounts already paid.
  9. All expenses related to medical management during pregnancy, delivery, and immediate postpartum period till adoption should be born by the intending couple.

Preservation, utilization and destruction of embryos:

  • Research is prohibited on embryos of more than 14 days after fertilization excluding the period during which the embryo was frozen with maximum storage period of 10 years and a 5 yearly review of semen and embryo deposits as practiced in other countries eg. U. K.

Spare embryos:

  • Embryo-splitting may be resorted to in selected cases for overcoming the paucity of suitable during ART in a couple. Child born of cryo-preserved embryos after divorce is deemed to be illegitimate.

Right of children / Parents

Children born from use of donor gametes and their social/adopted parents have the right to know whatever medical or genetic information about the genetic parents that may by relevant to the child's health.

Pre-conceptional or per-implantion sex selection is prohibited except for detecting specific sex-linked genetic disorders.

Bibliography

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  • The Indian Majority Act, 1875
  • The Medical Council of India Act, 1956
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  • The Medical Termination of Pregnancy Act, 1971
  • The (Extract of) Mental Health Act, 1987
  • The Pre-natal Diagnostic Techniques (Regulation and Prevention of Misuse) Act, 1994
  • The Transplantation of Human Organs Act, 1994
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