Artificial Insemination - In Vitro Fertilization and challenges caused to Legal System

Assisted Reproductive Technology

Any medical technique that attempts to obtain a pregnancy by means other than by intercourse is defined as Assisted Reproductive Technology. ART helps to solve the problem of childlessness. In other words these techniques manipulates the sperms and ooctes outside the body and the gamete of embryos are transferred into the uterus; ART includes Artificial Insemination (AI), In Vitro fertilization embryo transfer (IVF, ET), etc.
Scientific societies around the world, such as the ASRM, ESHRE and IFFS, have drawn up guidelines for the safe and ethical practice of ART. The European Union and the Governments of several countries such as Australia, the UK and the USA have taken steps to accredit and supervise the performance of infertility clinics. At present here are neither guidelines nor a legislation in regard to the practice of ART in India.

AI- Artificial Insemination

AI is the introduction of semen into the vagina or cervix of a female by any method other than sexual intercourse. There is evidence that people have been using artificial insemination to induce pregnancy in animals for centuries, and in recent times this procedure has become so simplified that it can be performed without the aid of a doctor or fertility specialist. It can be used to overcome both female infertility problems (where the cervix or fallopian tubes pose barriers to normal insemination). In human AI has become a useful to impregnate women who are physically capable of conceiving and bearing a child but who cannot do so through sexual intercourse, usually because there husband is sterile or impotent. Fresh semen is obtained from the husband or from some other male donor and is introduced by syringe into the women's vagina or cervix during her menstrual period. The semen can also have been previously stored in a sperm bank. This technique is reasonable successful in achieving conception and pregnancy. There are different types of artificial insemination.

1. A.I.H. Artificial insemination with semen obtained from the husband.
2. A.I.D. - Artificial insemination with semen obtained from a donor.

An AIH child raises no question of surrogate parenthood being a product of its own parent's seeds. It can be regarded as legitimate, and process of impregnation both justifiable and unobjectionable. In the case of AID, fertilization takes place inside the woman's body with two possible variations. An AID child is, thus, genetically linked to a parent outside its own family.

Earlier, a popular form of artificial insemination was AIC, in which the sperm of the husband and a donor were mixed. The advantage of this procedure was that it could not be conclusively stated that the husband was not the father of the child. This was important in an age where artificial insemination was considered to be immoral and tantamount to adultery, with the resulting child being considered as illegitimate and having no inheritance rights. With the acceptance of artificial insemination in society, the popularity of AIC diminished.

History of AI
Many people think of artificial insemination as a modern technology but it has a long history. Thus, apparently artificial insemination was attempted on Juana, wife of King Henry IV of Castile. In 1677 the Dutch scientist Anton van Leeuwenhoek saw spermatozoa through the newly invented microscope. Efforts to develop practical methods for AI were started in Russia in 1899. Papers on artificial insemination in horses had been published by 1922. By the mid 1940's artificial insemination

had become an established industry. In 1949 improved methods of freezing and thawing sperm were developed. The idea for adding antibiotics to the sperm solution came in 1950 from Cornell. Improved methods of sperm collection were developed in the 1970's and 1980's. Research to improve methods of artificial insemination continues and is usually studied under animal science curriculums.

AI is typically recommended for the treatment of infertility due to:
1. Mild to moderate male factor infertility
2. "Unexplained" infertility
3. Cervical mucus insufficiency
4. Hostile cervical mucus
5. Various structural abnormalities in the woman

AI And Challenges To Legal System

In India there is no legislation regarding artificial insemination. But the doctor has to follow general principal of law. A child born as a result of artificial insemination is considered as legitimate, provided the child was born during lawful wedlock.

Conception of the wife by AI does not amount to consummation of marriage; if there was no successful sexual act due to the impotence of the husband. The marriage can be declared null and void and in that case the child will illegitimate.

"AID" does not amount to adultery, even if it was done without the consent of the husband. For adultery to be committed both the parties should be physically present and engage in sexual act and sexual union should take place. AI is not equivalent to sexual intercourse (AIR 373-1984) AI does not contravene ethical principles of medical practice. The doctor while doing an insemination has to observe the following.
1. Doctor should obtain signed request from the wife and husband and wife
2. Should obtain a written informed consent from both the husband and wife.
3. Should keep detailed clinical records
4. The details of the donor should be kept as a secret in the case of A.I.D.
5. A female attainder nurse should be present at the time of insemination;
6. It is better to obtain the consent of the donor and his wife.
7. Should observe reasonable skill and care and prevent complications.

An AID child is practically divorced from the spiritual, mental emotional, and physical lives of the adoptive parents thus, besides the question of morality and human values involved in it, AID could give rise to the socio-legal issues listed below:
Before or after delivery-
Does AID amount to consummation of marriage? Does AID amount to adultery? Can the non-consenting spouse claim divorce, on the ground of adultery or non-consummation of marriage? Can the stranger donor of the male or female seed, claim to be the spouse of the accepting donee?

Post- Delivery:
Is the child of AID, a legitimate child? If so, to whom is the paternity or maternity of the child to be attribute? Is the woman's
non-consenting husband liable to maintain such a child as its father? What are the custodial or visitation rights of a surrogate father or mother? What would be the nature of relation of the AID child with a natural or adopted child, of the same family? Would the rule of prohibited degrees be operative on a child of AID? If so, when, how and with whom? How and from whom the child of AID would be entitled to inherit? Can it also be subject to rules of inheritance vis a vis consenting or not consenting relatives? Would the doctor be liable in law, following the birth of a defective child or failure of the process of AID?

Lamaritata v. Lucas (823 So.2d 316 (2002)) The donor and the recipient entered into a contract whereby the donor provided sperm to the recipient with the expectation that she would become pregnant through artificial insemination. The agreement provided that if childbirth resulted, the donor would have no parental rights and obligations associated with the child. The donor, in an attempt gain parental rights of the twin boys who were born to Ms. Lamaritata argued that he was not a sperm donor but instead the biological father, and thus should be afforded parental rights. Issue is does a sperm donor have any legal parental rights. Court held that In an attempt to avoid the enforcement of the contract, Mr. Lucas argued that he was not a sperm donor. Instead, he argued that he was part of a commissioning couple with the mother. A commissioning couple is defined as the intended mother and father of a child who will be conceived by means of assisted reproductive technology using the eggs or sperm of at least one of the intended parents. There were no facts to establish this, and the intent of the parties was established by contract. A person who provides sperm for a woman to conceive a child by artificial insemination is not a parent. Thus, the sperm donor here has no legal parental rights.

In Vitro Fertilization (Ivf) And Embryo Transfer (Et):

Commonly known as 'Test Tube Baby' IVF involves fertilization of an ovum outside the body and consequently transfer of embryo into the uterus of the woman. "In vitro" is Latin word mean "in glass", which referred as the test tubes, however neither glass nor test tubes are being used; the term is used generically for laboratory procedures. IVF is probably the most widely practiced assisted conception procedure in the world. The procedure does not need admission at any step and is conducted on an out patient basis. The success rate for each in vitro fertilization cycle is around 20-30%. Many factors affect success rates, including patient age, sperm and egg quality, reproductive health, duration of the infertility, and medical expertise. Because multiple embryos are often transferred, the risk of multiple births is the major complication in IVF.

History of IVF

The technique was developed in the United Kingdom by Doctors Patrick Steptoe and Robert Edwards. The first so-called "test-tube baby", Louise Brown, was born as a result on July 25, 1978 amid intense controversy over the safety and morality of the procedure.

The first in-vitro fertilization, to produce test tube baby "Durga" in India and second in the world was performed by a Calcutta based doctor Dr.Subhash Mukhopadhyay on October 3, 1978. Both these events caused public debate, criticism and even social professional ostracism of those involved in initiating life outside the body. Besides these obstacles the techniques of IVF has survived as a method of choice for treating some type of infertility.

The first successful IVF treatment in the USA (producing Elizabeth Carr) took place in 1981 under the direction of Drs Howard and Georgeanna Seegar Jones in Norfolk, Virginia. Since then IVF has exploded in popularity, with as many as 1% of all births now being conceived in-vitro, with over 115,000 born in the USA to date.

IVF is done in the following cases:
1. Women with blocked fallopian tubes
2. Ovulation problems.
3. Mild degree of seminal problems for the man.
4. Unexplained infertility cases.
5. Presence of seminal antibodies in the woman's body.

Steps involved in IVF Procedure

1. Ovarian stimulation by hormonal injections to produce multiple eggs
2. Monitoring of the response by ultrasound scans and blood tests
3. Egg retrieval with the help of a needle under local / general anesthesia
4. Fertilization of the eggs in laboratory
5. Transfer of the resulting embryo(s) into the uterus of the woman Blood test performed 15 days after embryo transfer, to assess the establishment of pregnancy. If the treatment procedure is successful, one or more of the embryos will implant in the uterus and pregnancy will result, just as it happens in the natural process of conception.

Another aspect of IVF, cryopreservation has in recent times gained popularity. Cryopreservation is the process of cooling and dehydrating an embryo to allow it to be stored for a long period of time. This process has gained popularity because it allows a woman undergoing IVF procedures to use possibly all of her retrieved and fertilized eggs. Cryopreservation eliminates the need to implant all of a woman?s resulting embryos at once, which something results in multiple pregnancies. In addition, the process reduces the number of time a woman may have to undergo egg retrieval if the first IVF attempts are unsuccessful in producing a pregnancy.

Regulatory events
In many countries t regulate many aspects of IVF practice. In such settings regulations may dictate:
� The number of oocyte that can be fertilized.
� The number of embryos that can be transferred.
� The use of cryopreservation.
� The use of third party reproduction.
� The ability to perform tests or interventions on the embryo.

Some problems of IVF
1. Eggs and Embryos have been stolen from women and given to other or to researchers.
2. Fertility drugs have been sold illegally.
3. Medical records have gone amiss.
4. Women recruited as surrogate mother have refused to part with the newborn baby that they have conceived to assist couples to bear a child.

5. India has been known to play host to visiting foreign IVF fertility experts to carry out such procedures that have been banned in the home country o9f visiting experts the case of injecting round spermatic into the egg cytoplasm is a good example of such misdemeanor.

6. Sale of eggs and embryos are subtly advertised over the internet by some IVF clinics in India. IVF costs approximately $10,000 per cycle, and it takes an average of four cycles to achieve a successful pregnancy

General Principles Related To Art
Informed Consent:
After duly counseling the couple / oocyte/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, ectopic 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 colours of the skin, eyes and hair, height and build, religious and ethnic background, the educational level and ABO blood type.

� 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 center 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 oocyte 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's 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 the potential recipient couple irrespective of whether they receive oocyte donation as planned or not.

Specific Principles

Legitimacy of the child born through ART:

A child born through ART shall be presumed to be the legitimate child of the couple, born within wedlock and with consent of both the spouses and with all the attendant rights of parentage, support and inheritance. Sperm/oocyte donors shall have no parental right or duties in relation to the child and their anonymity shall be protected. A child can be given status of legitimacy also by adoption. In Strand v. Strand. The husband had been given visitation rights in a divorce petition, but the wife later tried to have these rights rescinded in the ground that her child was illegitimate. She, however, admitted that she had undergone AID with her husband's consent. The court held that the husband should retain his right and because he had consented for AID the child was not illegitimate. According to the decision of the court the child had been ?potentially adopted or semi-adopted? by the husband, thus, he was entitled to the same rights as those acquired by a foster parents, who has formally adopted a child.

In Doombos v. Doombos (139, N.E.,2d 844 (1956))on a wife's petition for divorce and custody of the child born to her consequent to AID, consented to by the husband, one of the questions before the court was: whether such a child is legitimate and belongs to the mother only? The Court held that a child so conceived was not a child born in wedlock and therefore illegitimate. As such it was the child of the mother alone and the husband had no rights or interest in the child, not even that of visitation.

In another case Gursky v Gursky ((1963)242 N.Y.S. 2d 406) the Supreme Court of New York ruled that a child on the basis of an implied contract on his part or the doctrine of equitable-estoppel.

Anonymous v. Anonymous.((1964)246N.Y.S. 2d. 835) a husband had consented to his wife's therapeutic impregnation. On the wife's claim for alimony the husband pleaded that the child was illegitimate. Rejecting his plea, the court awarded the alimony on the ground that consents in writing carried with it an implied promise to furnish support for the resulting progeny.

In People v. Sorenson (1967) 62 Cal. Rep. 462 ) a man from California was, convicted of criminal non-support, sentenced to jail for one year on probation with an order to make support payments for a child born to his wife consequent to AID after his written consent during the wedlock. On appeal however, the court held that for the purposes if the criminal statute the husband was not the child's father.

Adultery in case of ART

ART 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.
The question whether recourse to AID in the absence of husband's consent amounts to adultery was probably raised for the first time before a Canadian court on Oxford v. Oxford(58 O.L.R. 251 (1921)). The husband petitioned for divorce on the ground of the wife's adultery. The wife asserted that the child born to her was the result of AID. The court disbelieved the wife and emphatically stated that such a woman commits adultery. However, no definite answer was given.

The court observed that
sexual intercourse is adulterous because in the case of the woman it involves the possibility of the introducing into the family of the husband a false strain of blood. Any act on the part of the wife which does that would, therefore, be adulterous.

In case of Doombos v. Doombos in January, 1956, before the superior court of Cook country, Illinois, the wife petitioned for declaration, inter alia, as to whether AID constituted adultery and whether it is contrary to public power. The trial court held that-
Heterologous artificial insemination with or without the consent of the husband is contrary to public policy and good morals and constitutes adultery on the part of the mother.

In Maclennan v Maclennan (1958 S.L.T. 12 ) wherein the scoattish trial court judge Lord Wheatly adhering to the traditional view laid down the following propositions from the English law.
� For adultery to be committed there must be the two parties physically present and engaging in the sexual act at the same time.
� To constitute the sexual act there must be act of union involving some degrees of penetration of the female organ by the male organ.
� It is not a necessary concomitant of adultery that male seen should be deposited in the female's ovum
� The placing of the male seeds in the female ovum need not necessarily result from the sexual act and if it does not, but is placed there by some other means (like AID), there is no sexual intercourse.

Supporting this view the Judge further clarified that:
Just as AI extracts procreation entirely from the nexus of human relationship on or outside the marriage, so does the extraction of the nexus of human relationship from the act of procreation remove AI from the classification of sexual intercourse. If the view is correct that AI by a donor without the consent of the husband is not adultery as the law interprets that term.

The question of adultery, as a result of AID, in India does not arise because under Section 497 of the IPC 1860, sexual intercourse must be present. Therefore, neither the recipient nor the donor of the seed would be guilty of adultery because there is no physical union in the form of coitus. Under the Indian law, but for the consent or connivance of her husband, commission of sexual intercours3e with a woman by a man, having knowledge or reason to believe that she is another's wife, makes him alone guilty of the offence of adultery. To such intercourse, penetration, irrespective of ejaculation, is an essential constituent.

Consummation of marriage and AID

A marriage is, actually, said to be consummated only when the parties have sexual intercourse, with full or at least partial penetration, after its solemnization. However, if a wife is inseminated artificially with the husband's seed and give birth to a child, does the conception or birth of the child constitute consummation of marriage? In an English case where the wife had become pregnant by AI with the husband's seed, it was argued that it was a voluntary act of the wife that led t conception and so the marriage should be treated as approbated

In R.E.L v. E.L,(1949 Probate Division 211)a psychologically impotent husband's wife took recourse to AIH and one year thereafter left the husband, without being aware of the fact that she had become pregnant. Subsequently, she gave birth to a child. After some time. She filed a petition for annulment of her marriage on the ground of husband's inability to consummate it. The question before the court was whether wife's willing recourse to AIH and subsequent birth of the child amounted to sufficient approbation of marriage so as to prevent her from seeking its annulment.

Rejecting this argument, the court granted the decree of nullity of marriage and observed:
If the child should be made illegitimate it is most regrettable, but the stigmas of birth are of less effect that they were, and the sons are not now judged by the errors of their parents.

In India the question whether AI amounts to consummation of marriage will be answered according to the personal law context in which it is raised. Thus under the Parsi Marriage and Divorce Act, 1936, non-consummation within one year of marriage owing to willful refusal of the respondent is a ground for divorce on the same ground, with no specific time limit either party can sue for a decree of annulment of marriage under the Special Marriage Act,1955 only the wife can seek annulment of marriage on non consummation of marriage due to the impotence of the husband.

Right of an unmarried woman to AID

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

Conclusion And Suggestion
With the increased use of advanced technology in assisted pregnancies, more and more families will be able to realize their dream of parenthood. Families must consider the legal consequences of the medical choices they are making. They should plan for the legal process by which the infant born to them will be legally acknowledged as their child. The birth of this long awaited child should not be clouded by anxiety or legal uncertainty.

In conclusion, it can be stated that in formulating an Indian law on Artificial Insemination and In Vitro Fertilization the following
fundamental issues will need to be necessarily tackled by policy makers:
� The ethical and moral consequences of AI and IVF.
� The primacy to be accorded to the biological need to bear a child.
� The repercussions of AI and IVF on the stability of family life.
� The socio-economic advantages, of adoption vis a vis AI
� The effect of AI and IVF on population control policy of the country.

Pending legislation doctors who perform AID on childless couples should observe the following precautions:
o Before performing the operation, the doctor should insist upon the knowledge and full consent of both the adoptive parents.

o To avoid the chances of any inconsistent claim the identity of the donor of the seed to the recipient-couple and vice versa should not be disclosed nor the donor should know the result of AID.

o To avoid the possibility of transmission of any genetic defect on to a child, the donor and the surrogate parent should be, free from all physical and mental defects.

o To avoid any kind of legal dispute, the consent in writing of the spouse of the donor or surrogate parent, for donation of seed or surrogacy as the case may be, should also be obtained by the doctor.

o To avoid the chances of prosecution of the doctor for any sexual or other offences, the presence of a nurse or a medical assistant should be compulsory when AI is performed embryo is transferred or seed is procured by the donor.

However, as already stated to have a proper sanction for all such propositions and to deal effectively with many other aspects of the medical practice of artificial insemination and in vitro fertilization, an independent and comprehensive legislation on the subject is required.

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