Donor Screening Process

Evaluation

The Food and Drug Administration (FDA) and other regulatory entities require a multi-step process to determine if an individual is eligible to become a sperm donor and to continue donating.  The first step involves reviewing the donor’s personal and family medical history.  The second step involves laboratory testing for relevant infectious diseases.  The third step involves a brief, targeted physical examination that focuses on clinical findings of and risk factors for infectious diseases.  After the initial evaluation, these steps are repeated at least once every 6 months to ensure that the donor remains eligible to continue donating.

In addition to FDA-required screening, Xytex performs advanced genetic testing on all donors, including hereditary cancer genetic testing, hemoglobin analysis, carrier screening for hundreds of inherited conditions, and chromosome analysis (karyotyping). 

*Prior to 2017, carrier testing of donors included a smaller number of conditions. Donor profiles list all conditions included in carrier testing. Xytex recommends downloading the actual test reports from donor profiles for careful review, as the reports contain important detailed information.

Screening

The process of becoming a sperm donor begins with in-depth screening. The health and medical history of our donors are of utmost importance. While each donor is different, they all go through the same thorough screening process.*

  1. Candidates complete a medical history questionnaire (MHQ), including detailed questions about personal health and family medical history.  
  2. A semen sample is collected for analysis to assess sperm count, volume, motility, and other factors that determine suitability for donation.  
  3. A Donor Coordinator conducts an in-depth interview covering personal and family medical history, along with a background check and education verification.  
  4. A psychological assessment is completed, including behavioral, psychosocial, and risk evaluations conducted by a clinical social worker and licensed clinical psychologist.  
  5. A brief, targeted physical exam is performed. 

At Xytex, the health and medical history of our donors is of utmost importance. While each donor is different, they all go through the same thorough screening process.

  1. Each candidate completes a medical history questionnaire (MHQ).
    Detailed questions will be asked about his health status and provide family medical history.
  2. Each candidate provides a semen sample for analysis.
    We assess sperm count, volume, motility and additional factors to determine the quality of the donation.
  3. Each candidate is appropriately vetted.
    A Donor Coordinator interviews the candidate about his personal and family medical history. During this step, the donor also undergoes a background check and education verification process.
  4. Each candidate undergoes psychological assessment.
    This process includes a complete behavioral analysis and psychosocial and risk assessments, completed by a clinical social worker and a clinical psychologist.
  5. Each candidate undergoes laboratory testing and a physical exam.
    Following the semen sample evaluation, blood and urine samples are taken during pre-screening and are periodically screened throughout continued sperm donation. Xytex screens all donors for possible Zika virus exposure.

Once a candidate has completed and passed all screenings, he is officially cleared to be a Xytex donor!

During active participation in the program, donors undergo a physical exam and a blood draw every six months.


*All donors entering the program after 2017

Donor privacy is very important to us. Donor and client agreements protect and release donors from any obligations or rights to a child that results from use of donor sperm. No identifying information is released to clients or offspring without the donor’s prior consent.

Questions developed by the FDA and U.S. Centers for Disease Control and Prevention (CDC) are included. Any affirmative answer to a required question disqualifies the candidate. All questionnaires are reviewed by and must be approved by our Medical Director for a candidate to continue through our screening process. FDA-mandated screening and testing also ensures our donors are in continued good health.

Please note that medical history provided by the donor is not validated by reviewing the donor’s or his family’s personal medical records.

 

Lab Testing

As part of our commitment to quality and safety, Xytex conducts laboratory testing and physical exams on all donors to assess overall health and ensure compliance with industry standards.

 

We test all donors for Cytomegalovirus (CMV), a common virus that most adults have been exposed to at some point in their lives. After the initial infection, CMV remains dormant in the body.

Donors with an IgG positive result, which indicates a non-active CMV infection, may still be accepted into the program. Donors with an IgM positive result, indicating an active infection, are not accepted.

If you have questions about a donor’s CMV status, we recommend discussing it with your physician before purchasing vials. Each donor profile includes an icon indicating CMV status. A positive or negative CMV result does not automatically qualify or disqualify a donor.

Genetic Testing

Comprehensive genetic testing is standard at Xytex. All donors joining our program undergo expanded carrier screening for hundreds of inherited conditions, and each donor profile includes a list of the specific conditions for which he has been tested. 

If there is a change in a donor’s genetic status, the donor profile is updated accordingly. 

Xytex also offers comprehensive hereditary cancer risk assessment using Natera’s 80+ gene Empower panel, providing intended parents with deeper insight into hereditary cancer risks and supporting more informed donor selection.

Additional Resources

Help, My Sperm Donor Is A Carrier Of A Genetic Disease
Video by Jamie K. Dokson, ScM, LCGC(Licensed Certified Genetic Counselor)

 

xyGene Donors

Each xyGene donor undergoes expanded carrier testing of over 100 genetic conditions. *

* Donors entering the program after January, 2019 have been screened for more than 280 carrier conditions:  Sema4

Negative genetic testing only reduces the possibility that a donor is a carrier of a particular condition.

Genetic testing changes over time and some donors may have been tested for fewer conditions. Donors who joined our program prior to 2012 may not have been tested for all conditions listed above.

While we do accept donors who are found to be carriers of genetic conditions, to purchase sperm of a donor known to carry a genetic condition, a client must provide proof that she does not carry the condition and has received genetic counseling. If a female is a known carrier of a specific genetic condition, we will provide a copy of the donor’s test reports to the physician and genetic counselor