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Gestational Surrogacy Program

Gestational Surrogacy is a type of 3rd party reproduction where a woman carries a baby for another couple that is genetically unrelated to her. This is distinct from Traditional Surrogacy where a woman uses her own egg and then gives up the baby. The Assisted Reproductive Technology (ART) procedures used in Gestational Surrogacy are no different than standard IVF or Egg Donation.

The complexity of Gestational Surrogacy involves the legal issues regarding giving birth to a child unrelated to the mother and the fact that laws vary from state to state regarding surrogacy. Some states forbid surrogacy and some seem to embrace it. We have found that Indiana, while declaring surrogate contracts unenforceable, does not forbid the act of surrogacy. Attorneys have crafted contracts that have worked well for both the Gestational Surrogate and Intended Parents. Attorneys can petition the courts for birth orders and have the Intended Parents named on the birth certificate. We can refer patients to very reputable Attorneys in order better understand the legal issues and help with birth orders and other important issues.

In addition to the legal concerns, it is imperative to address the psychosocial aspects of the procedure with a mental health professional. We have a certified counselor on-staff to help with this process and aid the patients through this process.

Lastly, the FDA considers Gestational Surrogacy a tissue donation. There are specific infectious disease blood tests that must be done at particular times in order for the program to be compliant with FDA regulations.

Indications for Gestational Surrogacy

There are several situations where a couple may consider using a Gestational Surrogate some of which are listed below:

  1. Absent uterus (congenital or surgical)
  2. Abnormal uterus
  3. Medical condition where pregnancy could be harmful to the mother
  4. Failed IVF
  5. Recurrent pregnancy loss
  6. Intra-uterine scar tissue
  7. Same-sex male couple

The FDA Regulations and Gestational Surrogacy

The FDA regulates Assisted Reproductive Technology laboratories and is primarily concerned with disease transmission, and appropriate screening and testing of patients. The crucial issue with testing is the distinction between anonymous donors and known or ‘directed’ donors. Full screening and testing is required for anonymous donors and not for directed donors. According to FDA, ‘directed reproductive donor’ means a donor of reproductive cells or tissue (including semen, oocytes, and embryos to which the donor contributed the spermatozoa or oocyte) to a specific recipient, and who knows and is known by the recipient before donation.

The FDA does not define what constitutes ‘who knows and is known by’ and leaves this up to the clinic. Whether the FDA will clarify this definition in the future is not known. The intent is clearly that one would not knowingly infect a known person like a family member, friend or close acquaintance, so screening and testing would not be required. It is within the FDA regulations to satisfy the definition of ‘known’ by merely meeting in the clinic office or local coffee shop. The purpose of this meeting in most cases is to make the donation a ‘directed donation’ which would be excluded from the testing required of anonymous gamete donors.

We feel that it is the best interest of the Intended Parents and Gestational Carrier to have complete testing as is done with anonymous donors. The FDA does not require gestational carriers to be screened and tested, however this is a requirement of Family Beginnings for the safety of all involved. It is difficult to see why anyone would not want thorough testing of the person carrying the baby. While this places a six-month quarantine on the sperm, the Gestational Carrier and Intended Parents will, during that time, complete psychological testing, legal consultation and medical evaluation.

The stimulation protocol may begin around month 4½ for an estimated embryo transfer shortly after the 6 months quarantine period.

Additionally, health insurance for the Gestational Carrier requires 3 months of coverage before pregnancy can be a covered benefit. A donor who would be ineligible for anonymous donation based upon sexual history in the screening process (i.e., gay male having had sex with another man in the previous 5 years) would be acceptable as a donor for a directed donation as noted above, as long as appropriate labeling is performed in the laboratory and the physician is notified. By adding the 6 months quarantine and treating the testing as an anonymous donation, Family Beginnings is holding our practice to a higher standard than what is required by the FDA and ensuring minimal risk of disease transmission to the GC.

Please call our office to discuss the program.

See Estimated Cost for Gestational Carrier.
 

 

 

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Phone:  317-865-0411 and 317-595-3665
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