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Isotretinoin vs hCG for Male Infertility Due to Low or Absent Sperm

StatusEnrolling by Invitation
PhasePhase 2
Started
View on ClinicalTrials.gov ↗

Record History

  1. Primary completion pushed from Nov 30, 2026 to Jun 30, 2027 Trial status changed: Not Yet Recruiting → Enrolling by Invitation · Completion pushed from Dec 31, 2026 to Dec 31, 2027 · Start date changed from estimate of Mar 1, 2026 to Apr 13, 2026 · 1 morev2 Show 4 more changesShow less
    • Trial status changed: Not Yet Recruiting → Enrolling by Invitation
    • Completion pushed from Dec 31, 2026 to Dec 31, 2027
    • Start date changed from estimate of Mar 1, 2026 to Apr 13, 2026
    • Site contact updated
  2. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
This study compares two medical treatments to see how well they improve sperm production in men with infertility due to low sperm counts (oligospermia) or no sperm in the semen due to non-obstructive causes (nonobstructive azoospermia). Some men with these conditions have limited nonsurgical treatment options, and current therapies do not work for everyone. Participants in this study will be adult men ages 19 to 50 who have been diagnosed with oligospermia or nonobstructive azoospermia and do not have a correctable cause for infertility. Eligible participants will be randomly assigned to receive one of two treatments for three months: oral isotretinoin taken twice daily, or human chorionic gonadotropin (hCG) injections given three times per week. hCG is a standard hormonal therapy used in certain types of male infertility, while isotretinoin is being studied for its potential role in stimulating sperm production. At the start of the study, participants will have blood tests to measure reproductive hormone levels and a semen analysis. Blood tests will be repeated at one month and three months, and a repeat semen analysis will be performed at three months, which corresponds to a full cycle of sperm development. The main goal of the study is to determine whether motile (moving) sperm appear in the semen after treatment. Additional goals include measuring changes in sperm count and hormone levels, as well as monitoring medication side effects. Both study medications are FDA-approved and have known side effect profiles. Participants may or may not experience improvement in sperm production. The results of this study may help guide future treatment options for men with infertility due to low or absent sperm production.
Trial Details
NCT Number NCT07481370
Lead Sponsor University of Nebraska
Conditions Oligospermia, Azoospermia, Nonobstructive, Infertility
Enrollment 100 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov