CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 20 enrolled
Drug / intervention
13-cis retinoic acid +1 moredrug
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/NCT02061384
NCT02061384Phase 2Completed

A Pilot Trial of 13-cis Retinoic Acid (Isotretinoin) for the Treatment of Men With Oligoasthenoteratozoospermia

University of Washington·interventional·Posted Feb 12, 2014·Updated Aug 2, 2021

In Brief

A Phase 2 clinical trial evaluating 13-cis retinoic acid and Calcitriol for Male Infertility and 2 related conditions. Completed, enrolled 20 participants across 1 site.

Detailed Summary

Men with infertility and normal hormone levels have few options for fertility treatment. Previous research work has suggested that men with infertility may have low levels of the active form of Vitamin A, called retinoic acid, in their testes. We think that giving men with low sperm counts retinoic acid may increase their sperm counts and improve their chances of fathering a pregnancy. We want to see if retinoic acid administration over twenty weeks can increase sperm production and help infertile men become fathers without the need for In vitro fertilization (IVF) and/or intracytoplasmic sperm injection (ICSI). We also want to see if adding calcitriol with retinoic acid will improve sperm motility in a sub-set of subjects.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

Phase 2CompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedFeb 12, 2014
Enrollment StartAug 1, 2014
Primary CompletionDec 1, 2018
TodayJul 2, 2026
Enrollment to primary: 4.3 yearsPosted 12.4 years ago

Interventions

13-cis retinoic aciddrug

Accutane is used for the treatment of severe acne

Calcitrioldrug

Calcitriol is a form of vitamin D given twice daily (BID)