About Kosher IVF

What Australian Clinics say about Kosher IVF

Halachic (Jewish legal) Supervision for Infertility Treatments

By Rabbi Yehoram Ulman 

Introduction

 

The area of Fertility Treatment is not devoid of concerns and issues. Not least of which is the mixing up of genetic material, be it intentional or accidental.

Over the decades of infertility treatments, there has been a not-insignificant amount of cases in which doctors or lab workers from various countries have deceitfully switched the genetic material of other people.[1] While the motivations may vary, the resultant outcome is no less devastating.

Similarly, working with such fine material, in many instance undiscernible to the naked eye, and with laboratories managing increasing numbers of cases simultaneously, the risks of human error are not insignificant. Indeed, an entire ancillary industry has sprouted, designing technological methods to avoid accidental mix ups. While much progress has been made in this regard, the possibility of human error or malice cannot be entirely ruled out. 

A critical component of the Halachic (Jewish Legal) permissibility for use of such treatment, revolves around ensuring that no such mistakes occur. 

To achieve this, highly trained Mashgichot, supervisors, are present throughout the process of the treatment of a given couple. From pick-up to embryo transfer and everything in between, a supervisor is present in the laboratories confirming that only the couple’s genetic material is being used and no mix up occurs. All of which will be explained later in greater detail.

It is important to note that the requirement for such supervision is imperative regardless of the personal trust the couple has to the medical and embryological staff. 

Halacha has always had foresight and predated the issues it seeks to address and from the earliest of authorities these issues were addressed. The need for supervision of such treatment, is discussed already in the 1950’s.[2] The strict protocol of artificial insemination supervision that was approved by the Lubavitcher Rebbe for is listed in the footnote.[3]

Notwithstanding the integrity of the laboratory, its workers and the systems it employs, according to Halacha one cannot rely on this trust alone, and all clinics would and cases would require Rabbinical supervision.

Qualifications to supervise infertility treatments

On matters pertaining to religious law, only Torah observant Jews are able to serve as halachic witnesses and supervisors. Apart from personal observance of Jewish law, when supervising fertility cases, the supervisor also needs to have a good understanding of the medical process enabling her/him to notice any irregularity or error, and pick it up before the tragic mix up or error occurs with devastating consequences.

Regardless of the faith of the embryologist or doctor, even a Jewish Orthodox-run laboratory, would require an independent G-d fearing, Torah observant supervisor to oversee the process for the process to be acceptable according to Halacha.[4]

 

Rabbinic Supervisor for an ART Procedure

As a general rule in Halacha, two kosher male witnesses are required in order to verify a matter as is recorded in Devarim 19:15 “…By the mouth of two witnesses, or by the mouth of three witnesses, shall the matter be confirmed.”

However, the Talmud (Gittin 2b) brings another rule that “one witness is believed on testifying on forbidden matters.”[5]

Additionally, the codifiers bring a plethora of sources regarding the admissibility of women as witnesses in relation to establish certainty over a matter.

 

The Rambam (Hilchos Eidus 5:3) writes: “any place where one witness is enough, a woman or ineligible witness may also testify.”

Thus although it is required to have hashgacha (rabbinical supervision) for an ART procedure, nonetheless, it would suffice to have even one G-d fearing trained supervisor, male or female.

Moreover, with regard to halachic supervision on infertility treatments the accepted custom is to use specifically women to be mashgichos (halachic supervisors).[6] This is due to the sensitivity and tznius, laws of modesty, which relate to these matters.[7]

 

The Ratz Katzvi (Even Haezer pg. 421) suggests that a woman mashgicha is tantamount to the concept of a chaya (mid-wife) who has the ability to label the yichus (Jewish status) of a child.[8]

 

The Rashba[9] explains that the reason a midwife is believed was enacted by the Sages “for it is impossible otherwise, for men do not deliver babies…”

 

Based on the above, it is self-evident that Jewish Law has complete confidence in the eligibility of women to provide evidence, and oversight, in areas uniquely pertaining to women and such sensitive areas of human experience.

Using a Mashgicha that is not employed by the Hospital or Clinic 

The question is raised, can a medical facility employ their own staff mashgichos to supervise the infertility treatments done in their lab?

It is the view of the author that only an outside agency can supervise infertility treatments and not the mashgicha appointed directly by the medical facility. This is to avoid all conflicts of interest.[10] This is analogous to the rule in kashrus supervision over food, specifically requiring an outside agency provide supervision over the establishment.

A.R.T Procedure where there was no Kosher Supervision

If a couple had already gone through an A.R.T. procedure such as an IUI or IVF or ICSI without any Halachic supervision, if there is any concern genetic material may have been switched a Rabbinic authority may require for a D.N.A. test be administered in order to ascertain that the baby is indeed the genuine baby of both parents.[11]

Conclusion:

Thankfully in most Jewish communities around the world couples can undergo fertility treatments without compromising halacha. It is imperative that even when a couple is using the services of a reliable hashgacha agency within the clinic the couple needs to seek guidance from a trusted halachik authority every step of the process.

 

This is because hashgacha is only part of the halachic parameters of the process and the challenges of infertility. 

Protocol for IVF supervision[12]

  1. If there are no medical reasons for infertility, the couple must receive a “heter” (consent) from a Rabbinic authority to undergo treatment. Moreover, even if a medical cause has been found, a heter must be sought authorising the particular treatment being advocated by the Medical professional. While a more aggressive form of treatment may guarantee quicker success, it may not be justified Halachically at that point in time, and more conservative treatments can be endeavoured at the outset. Since each case has its own unique challenges and practicalities, a competent Posek (Halachic authority) should be consulted throughout the process.

  2. Ideally, the egg retrieval (pickup) takes place after the wife has concluded her cycle (minimal 5 days ), waited 7 days and immersed in the “mikve” (ritual pool) which will enable the couple to resume marital relations which are required to produce the sperm sample. (If a women was unable to go to Mikve before, the cycle could become compromised. In some cases, the eggs can be retrieved and frozen, for insemination at a later date. However, this is not always a possibility. It is therefore recommended that, when the laboratory seeks to test for male factor infertility, the sample should be produced in the Halachically sanctioned manner. The sample is to be tested and frozen under supervision. This would allow its use at the time of pick-up if the women was unable to go to Mikve as mentioned. Furthermore, it is not uncommon for the man to struggle to produce a sample under such pressure. It is also not uncommon that the sample on the day is of a poor quality. The integrity of the cycle can thus be maintained by having a frozen backup sample available. 

  3. The sperm is to be collected during marital relations with a special condom approved by the clinic (often referred to as a “male factor pack”).[13]

  4. Every step of the process has to be supervised by either the Rabbi or by supervisors appointed by him. Egg retrieval and embryo transfer must be supervised by a female supervisor and sperm retrieval (such as TESE) by a male. (The Rabbi should be consulted as to the technique used for sperm retrieval.)

  5. The supervision begins with the culture media preparation. The Rabbi knows in advance the makeup of the media used in the clinic and all the ingredients (he should be informed of any changes in the media or the ingredients). The supervisor is present when fresh bottles are opened, witnesses the preparation and seals with special seals all the containers, incubators etc. where the media used for this particular couple is stored and signs the seals.

  6. The supervisor is present at all times of the process – media preparation, sperm preparation, egg pickup, insemination, embryo checking, cell separation for PGD (removed blastomere does not require supervision), transfer, freezing, thawing etc. The supervisor must stand next to and have a full view of any retrieval or transfer. Any time that the supervisor is not present all genetic material as well as media used for the supervised cycle must be sealed in the containers, incubators, in the liquid nitrogen tanks (there the straws containing the genetic material whether sperm, eggs or embryos are sealed in a tube/s used in the clinic for this purpose). The genetic materials needs to be double sealed by the mashgicha with a special seal which cannot be tampered with.[14]

 

Only the supervisor can break or supervise the breaking of the seal. Even in case of emergency (i.e. overheating of the incubator) the Rabbi (or in his absence a member of his team) should be called even in the middle of the night and a supervisor will come to supervise the breaking of the seal and/or any other activity, sealing the genetic material before leaving.  At no time can the seal be broken without supervision.

  7. The supervisors, whether male or female cannot be the couple undergoing the cycle or anyone working for the clinic.

  8. While the embryologists / andrologists etc. are working on the supervised cycle, no other genetic material from another couple may be present on the counter at that time.

  9.All instruments used for the supervised cycle are to be freshly opened (as is the standard procedure in all clinics anyway) in front of the supervisor.

  10. All genetic material must be disposed of while the supervisor is watching. In the case of sperm and eggs (not the embryo) some solution (liquid soap for example) should be mixed in the material before discarding.  Sperm testing and discarding after the tests in IVF labs should also be supervised.

  11. When sperm and eggs are retrieved and frozen not for the purpose of an immediate cycle but to allow the couple to have children in the future ( i.e. before chemo therapy) or when a single person freezes eggs/sperm to allow them to have children after they get married, supervision and sealing must take place.

  12. Before the transfer, when the embryo/s is taken out of the incubator, the supervisor looks at the embryo/s through the microscope and seals the rest (if there are more) in the incubator. After the transfer she is shown that the catheter is empty before everything is discarded. Generally the supervisors look in the microscope at different stages of the process (after egg retrieval, embryo checks etc.).  

  13. No work connected to supervised cycle takes place on the Shabbos (begins before sunset on Fridays and ends an hour after sunset on Saturdays) or on Jewish Holy Days. There are a couple of periods with a few Holy Days one after another and therefore there should be consultation with the Rabbi before commencing a cycle.[15]

  14. It is possible that some points were missed out in this protocol and if/when noticed will be included.

 

FOOTNOTES 

[1] Some of the notorious doctors who deceitfully fathered multiple children with their own sperm include: Cecil Jacobson, Jan Karbaat, Bertold Weisner, Norman Barwin, etc…

[2] See Kovetz Noem (vol. 1 pg. 157) from Rabbi Shlomo Zalman Auerbach. See also Tzitz Eliezer (vol. 9 Siman 51 Perek 4). See also Yabia Omer (vol. 2 Even Haezer Siman 1). In Nishmas Avraham (vol. 3 pg. 20) it brings in the name of Rabbi Shlomo Zalman Auerbach that it is enough to have one trustworthy Jewish Orthodox doctor, however it is much more proper that everything should be done in front of two trustworthy individuals.

[3] In Assia (61-62) pg. 55 it brings that Rabbi Feigelstock (Rav of Chabad community of Buenos Aires) on the 12th of Nissan 5752 wrote a Psak Din consisting of eight conditions for an allowance of artificial insemination which the Rebbe gave his agreement to. The eight conditions are the following:

1) The treatment should take place in Tahara days after immersion in a mikvah.

2) The production of semen should be like the way of the land, i.e. marital relations with the husband wearing a special condom (with no spermicide in it) which can protect the semen.

3) Careful supervision of the semen through a religious Jew who also understands in medical issues who could not be tricked.

4) All the vessels where the semen will be placed should be checked that they are absolutely clean. After the semen is removed there should not remain any remnants of semen so they cannot possibly be used for someone else. Any remaining semen should effectively be destroyed though adding water to the remnants in the container.

5) That the supervision of the semen should be done by a woman.

6) That the husband should not watch over his semen, for he is emotionally connected and easily flustered as a result.

7) The woman watching the semen should ensure that no other biological material else was added in the semen.

8) This supervision needs to be from beginning until the absolute end literally, (which is when the semen in fully injected in the uterus). Any lack of supervision can ruin and forbid the entire process.

[4] It is told over that the venerable Posek, Rabbi Yosef Shalom Elyashiv told Rabbi Menachem Bornstein (the director of PUAH) that even if he (Rabbi Elyashiv) were to be a doctor performing the A.R.T. procedure, nonetheless one would need to place a mashgiach. This is since one needs absolute knowledge on matters that reflect Yuchsin (Jewish genealogy) and not just good faith.

[5] Rashi (ibid) explains that one witness is believed to testify on forbidden matters just as one is believed to say that they separated Terumah or that they did a proper shchita (ritual slaughter). Whereas Tosfos (ibid) explains that one witness is believed as we find by the Niddah (menstruating woman) “that she counts (the days)” – by herself.

[6] A female supervisor is also known as a mashgicha.

[7] Also due to the fact that the lab workers are usually women and also that one might encounter the mother to be, therefore to avoid tznius issues or yichud situations the supervisor is a woman.

[8] See Kidushin 73b.

[9] Shu”t HaRashba vol. 2 Siman 182.

[10] Infertility treatments are extremely costly and therefore the supervisor should have no conflict of interests.

[11] The consensus of the Poskim is that one may not allow fertility treatments without halachic supervision even post-facto by “following the majority” or relying on a chazaka (status quo) of “a professional will not ruin his reputation” since the consequences in a mix-up case  are so severe. Additionally, the fact is there have been numerous recorded cases in which mix ups took place proves one cannot rely on these factors. And all this is in order to protect the sanctity of the Yichus (genealogy), knowing with certainty who both the father and the mother in fact are. See also Ratz Katzvi (Even Haezer pg. 437) which brings that by Yuchsin (family issues) one needs to take extra precautions (see Kesubos 14b) which is more stringent than other fields in Halacha. See also Ratz Katzvi pg. 444 from a letter from Rabbi Yukesiel Farkash of Jerusalem.

[12] This protocol is based on the protocols written by Rabbi Feigelstock in 5751 with the approval of the Lubavitcher Rebbe. This protocol was written by Rabbi Yehoram Ulman as a more expanded version. This is also standard protocol by many Rabbonim.

[13] The condom will not be laced with spermicide. There is usually some sort of hole in the condom that technically could allow potentially some sperm to enter into the vagina. This would not be done in cases of treatment undertaken to avoid genetic diseases.

[14] The Talmud Avoda Zara 39a rules that various items and foods that do not have an identification sign are forbidden if not watched unless they are double sealed.

There is a dispute among the Rishonim as to the reason various items require two seals. Rashi explains that valuable items require two seals so as to prevent a one from switching it with something less valuable. However the Rashba holds that the Talmudic rule that requires two seals applies to all Biblically forbidden items if they were to be mixed up. See Tur to Yoreh Deah 118.

The Shulchan Aruch rules of the requirement for double seals for various foods and wine. See Shulchan Aruch (Yoreh Deah 118:1).

It is obligatory that genetic material kept in a laboratory have double seal so as to prove that they were not tampered with. If one is concerned with various foods that they require double sealing certainly the same should apply with regards to genetic materials. 

It is also imperative that the mashgicha not leave the genetic materials (which are not double sealed) unattended even for a smallest amount of time for the concern that it be switched. See Shulchan Aruch (Yoreh Deah 63).

[15] Every precaution should be done in order to prevent procedures from taking place on Shabbos and Yom Tov for two reasons: 1) the procedures are Shabbos violations and 2) the mashgicha would need to be present and this is impossible for her come on Shabbos. 

In many places the agreement between the Rabbinic agency providing the supervision and the clinic is no work may be done on Shabbos whatsoever. In a situation that a clinic does a procedure under extraordinary circumstances the Rabbinic authority would give guidelines of all Shabbos hashgacha (supervision) and for the medical and embryogical staff.

In extenuating circumstances it could be that a procedure such as egg retrieval would need to take place just prior or after Shabbos. All issues would need to be verified with a Rav expert in this field.

In such a case, a mashgicha would need to be there to supervise the entire procedure.

A Jewish View of Infertility and its Treatment

Infertility is not a recent phenomenon. On the contrary, three of the four biblical matriarchs suffered from infertility. The Torah, or Old Testament, documents in Genesis the suffering of Sarah, Rebecca and Rachel due to infertility. The narrative details much of the human drama in the relationships between the matriarchs and their husbands, and the matriarchs and God.

Jewish law and assisted reproduction

In the 21st century, most rabbis agree that the commandment to populate the world is so important that many technological developments for assisting infertile couples are permitted by Jewish law. They say that in case natural reproduction does not succeed, it gives a tacit approval for assisted reproduction. The implied flexibility of the Torah regarding assisted reproduction is not surprising. After all, the three matriarchs dealt in different ways with their tragic circumstances. Sarah bitterly resigned herself to not having children, and even laughed cynically when presented with the possibility of conception at an advanced age. Rebecca was more positive. She asked Isaac to intervene on her behalf and Isaac’s prayers were answered. Rachel, on the other hand, used herbs called dudaim. This form of assisted reproduction achieved its goal. Rachel was finally remembered by God, and she conceived and bore Joseph.
 

Kosher IVF

Nowadays couples have access to a range of treatment options, depending on their circumstances. Under Jewish law, medical intervention including IVF is permitted and encouraged when needed. The primary concern is correct identification of sperm, eggs and embryos. Any gap in tracing these would raise serious halachic implications for the identity of the child. Kosher IVF involves the verification of samples and integrity of the procedures by having a Rabbi or his or her delegate witness each step of the process. They supervise all procedures to ensure that there is continuity of people and their samples. At Genea, embryos have their own incubators, and the Rabbi places a special seal on canisters for frozen embryos.
 

Status of the pre-implantation embryo

Judaism could be unique in its view on the status of the pre-implantation embryo. Until 40 days, most rabbis consider an embryo to be "mere water". A foetus prior to 40 days gestation is not considered to be an actual person and, extrapolating, the destruction of such a foetus is not forbidden by Jewish law. If the pre-embryo may be destroyed, it certainly may be used for research purposes and other life-saving work, including stem cell research and saviour siblings. Nevertheless, it is important to realise that this conclusion is not accepted unanimously.

 

Disclaimer: Please note that this is a Genea Group blog and as such information may not be relevant for all clinics. We advise that you consult clinics directly for further information

Posted 23 Sep 2014 by Genea Fertility 

Respecting your beliefs

At IVFAustralia, we understand that you may have specific concerns about fertility treatment, based on your religious beliefs or cultural background. So, we have specialists available to ensure we can provide you with a treatment plan that is acceptable to your faith or situation, ensuring assisted conception is accessible to all.

Jewish community

If you require supervised IVF that adheres to Halacha, IVFAustralia has fertility specialists experienced in treating patients of the Jewish faith.

Throughout this process, a Rabbi and qualified female supervisors witness every step of the IVF process, including laboratory and day surgery procedures. Your treatment is also co-ordinated to ensure that no laboratory or treatment processes take place on a Saturday.

IVFAustralia has fostered a strong collaborative relationship with Rabbi Ulman, one of Sydney's most respected Jewish authorities on halachically acceptable fertility treatment.

Adapted from www.ivf.com.au

The Above text was prepared as a chapter in a book to be published by Dr Isaac Benjamin Fhima - Caracas, Venezuela.

 Dr Fhima's clinic is under Rabbi Ulman's Hashgacha