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

Part of paid clinical trials in Omaha, Nebraska.

Sponsor
University of Nebraska
Study ID
NCT07481370
Phase
PHASE2
Status
Enrolling By Invitation

Conditions

  • Azoospermia, Nonobstructive
  • Infertility
  • Oligospermia

Eligibility Criteria

Sex
MALE
Age
19 Years - 50 Years
Healthy Volunteers
Not accepted

Interventions

  • isotretinoin — DRUG
    Oral isotretinoin administered at a dose of 20 mg twice daily for 3 months as part of a randomized treatment arm evaluating effects on sperm production and reproductive hormone levels.
  • Human chorionic gonadotrophin (hCG) — DRUG
    Human chorionic gonadotropin (hCG) administered by subcutaneous injection at a dose of 2,000 units three times weekly for 3 months as part of a randomized treatment arm evaluating effects on sperm production and reproductive hormone levels.

Study Details

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.

Key Dates

Start date
Apr 13, 2026
Status verified
Apr 2026
Primary completion
Jun 30, 2027
Completion
Dec 31, 2027

Study Design

Enrollment
100 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Isotretinoin Treatment Arm
    Participants in this arm will receive oral isotretinoin 20 mg twice daily for 3 months. Reproductive hormone testing will be performed at baseline, 1 month, and 3 months, and a semen analysis will be repeated at 3 months to assess treatment response.
  • Active Comparator: hCG Treatment Arm
    Participants in this arm will receive human chorionic gonadotropin (hCG) injections at a dose of 2,000 units three times weekly for 3 months. Reproductive hormone testing will be performed at baseline, 1 month, and 3 months, and a semen analysis will be repeated at 3 months to assess treatment response

Primary Outcome Measure

Presence of Motile Sperm in the Ejaculate [ Time Frame: 3 months ]

Locations (1)

FacilityCityStateZIPSite coordinators
University of Nebraska Medical CenterOmahaNebraska68198-

Find similar trials in Omaha, NE

By research site
University of Nebraska Medical Center· Omaha, NE

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