Identifying Genome Variants in Non-Obstructive Azoospermia (NOA) or Primary Ovarian Insufficiency (POI)

Part of paid clinical trials in Bethesda, Maryland.

Sponsor
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Study ID
NCT07357701
Status
Recruiting
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Conditions

  • Azoospermia
  • Oligospermia
  • Primary Ovarian Insufficiency

Eligibility Criteria

Sex
ALL
Age
18 Years - 100 Years
Healthy Volunteers
Not accepted

Study Details

Background: Infertility affects 1 in 6 people. Often, the causes of infertility are unknown. Treatments are successful in only about 50% of cases. Infertility caused by non obstructive azoospermia in males and primary ovarian insufficiency in females can have genetic causes. Researchers want to learn more about these genes. Objective: To identify genes that may cause infertility. Eligibility: Adult men and women with non-obstructive azoospermia (NOA) or primary ovarian insufficiency (POI) of unknown cause. Design: Participants will provide a saliva sample. A kit will be sent to their home. The kit will contain a collection tube and a cotton swab. They will swirl the swab inside their mouth and then seal it in the tube. They will mail the tube back to the researchers. Male participants who are having a procedure done to collect tissue from their testes may opt to have leftover tissue provided to study researchers. This tissue would otherwise have been discarded. No new procedures will be performed just for this study. Data may be collected from participants medical records.

Key Dates

Start date
Mar 11, 2026
Status verified
Mar 2026
Primary completion
Jan 1, 2031
Completion
Jan 1, 2031

Study Design

Enrollment
500 participants (estimated)

Arms

  • Arm: Non obstructive azoospermia
    Men aged 18 and older who have no semen in the ejaculate with no evidence of pathologic transport of sperm
  • Arm: Oligospermia
    Men aged 18 or older who have a concentration less than 5 million/mL in ejaculate with no other known cause of oligospermia.
  • Arm: Primary ovarian insufficiency
    Women who have been diagnosed with primary ovarian insufficiency

Primary Outcome Measure

Genetic associations with infertility (primary ovarian insufficiency, oligospermia, non obstructive azoospermia) [ Time Frame: 5 years ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
National Institutes of Health Clinical Center (Remote and In-Person)BethesdaMaryland20892-
Shady Grove FertilityRockvilleMaryland20850-

Find similar trials in Bethesda, MD

By research site
National Institutes of Health Clinical Center (Remote and In-Person)· Bethesda, MDShady Grove Fertility· Rockville, MD

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