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

Summary

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.

Conditions

• Oligospermia
• Azoospermia, Nonobstructive
• Infertility

Interventions

DRUG

isotretinoin

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.

DRUG

Human chorionic gonadotrophin (hCG)

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.

Sponsors & Collaborators

• University of Nebraska

  lead OTHER

Principal Investigators

• Chris Deibert, MD, MPH · University of Nebraska

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

19 Years

Max Age

50 Years

Sex

MALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2026-04-13

Primary Completion

2027-06-30

Completion

2027-12-31

FDA Drug

Yes

Countries

• United States

Study Locations