SCREENING

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

  1. Each candidate completes a medical history questionnaire (MHQ).*
    He will answer detailed questions about his health status and provide family medical history. **
  2. The candidate provides a semen sample for analysis.
    We assess sperm count, volume, motility and additional factors to determine quality of the donation.
  3. The 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. The 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.

A donor’s privacy is very important to us. Donor and patient agreements protect and release donors from any obligations or rights to a child that results from participation in our donor program. No identifying information is released to patients or offspring without donor’s prior consent.

TESTING

As part of our commitment to provide families with the highest quality sperm, Xytex conducts laboratory testing and physical exams on all of our donors to assess their overall health.

Initial lab testing includes:

  • Complete blood count
  • Blood typing
  • HIV 1/2 + O antibody testing
  • HIV/HCV/HBV NAT
  • Hepatitis B surface antigen
  • Hepatitis B core antibody testing
  • Hepatitis C antibody testing
  • Cytomegalovirus antibody testing (total). If total is positive, then IgG & IgM are tested ***
  • Syphilis serology (treponemal-specific testing)
  • HTLV I & II antibody screening
  • Full genital culture which includes testing for gonorrhea
  • Urine PCR testing for chlamydia and/or gonorrhea
  • West Nile Virus (NAT) Assay

GENETIC TESTING

We conduct genetic testing on all of our donors to help you confidently choose for your family.

We test our donors for carrier status of more than three dozen common genetic conditions:

  • Abetalipoproteinemia (MTTP)
  • Alport Syndrome (COL4A3)
  • Arthrogryposis, Mental Retardation and Seizures (AMRS)
  • Bardet-Biedl Syndrome (BBS2-related)
  • Bloom Syndrome (BLM)
  • Canavan Disease (ASPA)
  • Carnitine Palmitoyltransferase II Deficiency (CPT2)
  • Congenital Amegakaryocytic Thrombocytopenia (MPL)
  • Cystic Fibrosis (CFTR)
  • Dihydrolipoamide Dehydrogenase Deficiency (DLD), also known as Maple Syrup Urine Disease Type 3
  • Ehlers-Danlos Syndrome Type VIIC (ADAMTS2)
  • Familial Dysautonomia (IKBKAP)
  • Familial Hyperinsulinism, ABCC8-Related (ABCC8)
  • Fanconi Anemia Group C (FANCC)
  • Galactosemia, GALT-Related
  • Gaucher Disease (GBA)
  • Glycogen Storage Disease Type Ia (G6PC)
  • Joubert Syndrome 2 (TMEM216)
  • Maple Syrup Urine Disease Type 1A (BCKDHA)
  • Maple Syrup Urine Disease Type 1B (BCKDHB)
  • Mucolipidosis Type IV (MCOLN1)
  • Multiple Sulphatase Deficiency (SUMF1)
  • Nemaline Myopathy, NEB-Related (NEB)
  • Niemann-Pick Disease Type A (SMPD1)
  • Niemann-Pick Disease Type B (SMPD1)
  • Phosphoglycerate Dehydrogenase Deficiency, PHGDH-Related (PHGDH)
  • Polycystic Kidney Disease, Autosomal Recessive (PKHD1)
  • Retinitis Pigmentosa 59 (DHDDS)
  • Smith-Lemli-Opitz Syndrome (DHCR7)
  • Spinal Muscular Atrophy (SMN1)
  • Tay-Sachs Disease (HEXA)
  • Tyrosinemia Type 1 (FAH)
  • Usher Syndrome Type IF (PCDH15)
  • Usher Syndrome Type III (CLRN1)
  • Walker-Warburg Syndrome, FKTN-Related (FKTN)
  • Wilson Disease (ATP7B)
  • Zellweger Spectrum Disorder, PEX2-Related (PEX2)

We also screen the following conditions:

  • Alpha-Thalassemia
  • Beta-Thalassemia
  • Chromosomal Abnormalities
  • Sickle Cell Disease

Each donor’s profile includes a list of genetic conditions for which he has been tested, if there is a change in status, the donor’s profile is updated with the new information.****

XYGENE DONORS

Our xyGene donors are an option for women who have been tested and found to be carriers of conditions for which most sperm donors are not tested.

Each xyGene donor undergoes expanded carrier testing of more than 170 genetic conditions.

Additional tests include, but are not limited to:

  • 21-Hydroxylase-Deficient Congenital Adrenal Hyperplasia
  • (CYP21A2)
  • Alpha-1 Antitrypsin Deficiency (SERPINA1)
  • Alpha-Thalassemia (HBA1/HBA2)
  • Beta-Thalassemia (HBB)
  • Familial Mediterranean Fever (MEFV)
  • Galactosemia (GALT)
  • Krabbe Disease (GALC)
  • MCAD Deficiency (ACADM)
  • Phenylalanine Hydroxylase Deficiency (PAH)
  • Polycystic Kidney Disease, Autosomal Recessive (PKHD1)
  • Pompe Disease (GAA)
  • Smith-Lemli-Opitz Syndrome (DHCR7)
  • Very Long Chain Acyl-CoA Dehydrogenase Deficiency (ACADVL)
  • Wilson Disease (ATP7B)
  • Zellweger Spectrum Disorder, PEX1-Related (PEX1)

*Questions developed by the U.S. Centers for Disease Control and Prevention (CDC), are also included. Any affirmative answer to a CDC question automatically disqualifies a potential donor. All questionnaires are reviewed and must be accepted 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.

***We test all donors for Cytomegalovirus (CMV), an extremely common virus that nearly every adult has at one time or another. Although dormant after the initial infection, CMV stays in the body’s system for life. We accept samples from a donor with an IgG positive result, which indicates a non-active CMV infection. An IgM positive result indicates an active CMV infection and the donor is considered unacceptable. If you have any questions or concerns, we suggest you discuss the CMV status of a donor with your doctor prior to purchasing units. You will note the appropriate icon beside each donor to reflect his CMV IgG status. Whether the icon indicates positive or negative does not qualify or disqualify the donor.

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.