Male Donor Eligibility Qualification

The path to parenthood is unique for every couple, and sometimes, the journey may involve a gestational carrier or surrogate.  There are a multitude of reasons that we discussed in a recent blog. A few definitions and an overview of the process follows.

We purposely differentiate a gestational carrier from a surrogate.  A surrogate, often referred to as a traditional surrogate, is a woman who shares a genetic link to the child, while a gestational carrier is a woman who agrees to carry and deliver a child for another couple or individual. The gestational carrier does not have any biological connection to the child.

An embryo is created by fertilizing an oocyte (egg) from the female donor and sperm from the male donor. The embryo is then placed in the uterus of the gestational carrier/surrogate. The male and female donors often are sexually intimate partners and know the gestational carrier/surrogate. They are therefore considered to be Directed Donors by the regulatory authorities. Directed donors must undergo required testing and their eligibility as a donor must be certified by a Physician licensed by the NY State DOH to perform donor eligibility determination before the embryo can be implanted into the gestational carrier/surrogate. This process is regulated by both the FDA  and the NY State Department of Health.

Qualifying the Male Directed Donor involves THREE STEPS:

1. CONTACT US BY EMAIL, PHONE OR ONLINE. We will ask you for some basic information, send you forms to complete, and schedule a virtual consultation.

2. TELEMEDICINE CONSULTATION WITH OUR MEDICAL DIRECTOR
    1. A written informed consent from the male directed donor is obtained after our Medical Director has explained the procedures for collection, storage, retrieval, dispensing of specimens, and use of blood, urine, and semen screening rationale and techniques, details, of privacy and responsibilities of both the Directed Donor and the Recipient. The discussion will include:
    2. Discussion of the process of Donor qualification.
    3. Informing the donor that his name and address will be kept on file, and the restrictions on releasing donor-identifying information as specified in NY State Department of Health section 52-8.9 .
    4. The required donor testing, a review of the Donor’s history, a physical examination, semen analysis, and genetic and infectious disease marker testing.
    5. Informing the Donor that his medical history information and testing results will be released to his physicians and the gestational carrier/surrogate in compliance with NY State requirements for disclosing this medical information.
    6. Informing the Donor that Eligibility Determination will be made by the Medical Director.
    7. Informing the Donor that prior to the release of Specimens, a Summary of Records will be forwarded to the Recipient’s inseminating physician for review and confirmation of release.
    8. A complete medical history, both individual and family, including first-degree and second-degree relatives, will be reviewed together with genetic and psychological screenings that might have been performed.

3. IN-OFFICE APPOINTMENT
    1. A physical examination will be performed.
    2. Blood testing for sexually transmissible diseases and other required blood testing.
    3. Review of genetic testing for major genetic disorders and consultation with a NY State licensed genetic counselor approved by NY Cryo.
    4. Review of psychological evaluation and counseling by a NY State licensed specialist approved by NY Cryo to assess psychological risks and evaluate for financial and emotional factors.
    5. Evaluation, processing, and cryopreservation of a semen specimen
    6. Additional specimens can be collected. Repeat blood testing is required six (6) months after the date of collection of each specimen.  Each specimen must have blood tests drawn within 7 days of specimen collection.
    7. Specimens are quarantined as required by NY State regulations.

Based on the questionnaires you completed, laboratory testing, and consultations, our Medical Director will make an Eligibility Determination and notify you and your partner’s Physician. The specimens will either be found to be eligible or ineligible for use in creating an embryo for implantation in a gestational carrier/surrogate.

Eligible specimens (or the embryos created from them) are then quarantined for six months, after which the donor is re-tested for the required infectious disease prior to release for implantation. NY State allows for a waiver of the six-month quarantine if the waiver is signed by the recipient of the donor tissue and agreed to by the implantation facility.

Ineligible semen samples are those that do not meet the eligibility criteria set by the U.S. Food and Drug Administration (FDA). A shared decision process decides the use of ineligible samples between the recipient of the donor tissue and the implantation physician after discussing the risks and often after an informed consent is signed.

Fees for Male Donor Eligibility Determination can be found here.

Please call us at 516-487-2700 ext 105  or email info@nycryo.com