CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 10 enrolled
Drug / intervention
13-cis retinoic aciddrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03323801
NCT03323801Phase 2Completed
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A Pilot Trial of 13-cis Retinoic Acid (Isotretinoin) for the Treatment of Men With Azoospermia

University of Washington·interventional·Posted Oct 27, 2017·Updated Oct 26, 2021

In Brief

A Phase 2 clinical trial evaluating 13-cis retinoic acid for Male Infertility, Azoospermia. Completed, enrolled 10 participants across 1 site.

Detailed Summary

Men with infertility and normal hormone levels have few options for fertility treatment. Previous research suggests that men with infertility may have low levels of the active form of Vitamin A, called retinoic acid, in their testes. In a pilot study of 20 men with low numbers of sperm (\<10 million motile sperm), roughly half the men showed improvement in sperm production. Thus, we want to see if retinoic acid administration to men with azoospermia (no sperm present) can initiate sperm production.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMale Infertility, Azoospermia
CountriesUnited States
CollaboratorsEunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Timeline

Phase 2CompletedFinished
201820192020202120222023202420252026
First PostedOct 27, 2017
Enrollment StartJul 25, 2017
Primary CompletionMay 16, 2019
Study CompletionMay 31, 2019
TodayJul 2, 2026
Enrollment to primary: 1.8 yearsPosted 8.7 years ago

Interventions

13-cis retinoic aciddrug

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