NCT07481370
Isotretinoin vs hCG for Male Infertility Due to Low or Absent Sperm
Enrolling by Invitation
PHASE2Ages 19–50InterventionalTreatmentUniversity of NebraskaInvestigator-initiated
~100 participants
Updated 2026-04-20 on ClinicalTrials.gov
What's tested:isotretinoinHuman chorionic gonadotrophin (hCG)
At a glance
Recruiting sites
0 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Presence of Motile Sperm in the Ejaculate
Measured over 3 months
Conditions
Where it's being run
1 sites across 1 statesNebraska1
Study leadership
- Chris Deibert, MD, MPH · PRINCIPAL_INVESTIGATOR · University of Nebraska
Who to contact
This trial hasn't published a contact. View it on ClinicalTrials.gov
Do you actually qualify for this trial?
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Eligibility criteria
Inclusion
Male participants aged 19 to 50 years
Confirmed diagnosis of oligospermia (sperm concentration \<15 million/mL), nonobstructive azoospermia, or hypogonadotropic hypogonadism (defined by low or normal FSH with low testosterone)
Normal genetic evaluation if diagnosed with azoospermia
No other identified and correctable cause of infertility
Considered appropriate candidates for medical therapy for infertility in the clinical judgment of the investigators
Willing and able to comply with study procedures, including laboratory testing, semen analyses, and follow-up visits
Able to provide informed consent
Exclusion
Obstructive azoospermia (including vasal obstruction, ejaculatory duct obstruction, or prior vasectomy)
Prior successful medical therapy for infertility
Current or recent use of medications known to impair spermatogenesis, including exogenous testosterone or anabolic steroids, unless discontinued with adequate washout
Current use of isotretinoin for any indication
Contraindications to isotretinoin (including significant liver disease or uncontrolled hyperlipidemia)
Contraindications to human chorionic gonadotropin (including hormone-sensitive malignancy)
Significant medical or psychiatric conditions that, in the opinion of the investigators, would interfere with safe participation
Inability to provide semen samples
Inability to provide informed consent
What this trial measures
- Presence of Motile Sperm in the Ejaculate3 months
Assessment of whether motile (moving) sperm are present in the ejaculate following treatment with isotretinoin or human chorionic gonadotropin (hCG), as determined by standard semen analysis