Phase 2 N=10 Treatment

RA-4: 13-cis Retinoic Acid for Treatment of Men With Azoospermia

Male Infertility, Azoospermia

Bottom Line

View on ClinicalTrials.gov: NCT03323801 ↗

Enrolled (actual)

Serious AEs

10.0%

Results posted

Oct 2021

Primary outcome: Primary: Total Motile Sperm — 8; 1 Participants

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: 13-cis retinoic acid (Drug)
Age: Adult · 21+ yrs
Sex: Male
Sponsor: University of Washington
Primary completion: May 2019

Outcome Measures

Outcome	Result	p-value
PRIMARY Total Motile Sperm	8; 1	—
PRIMARY Total Sperm and Percentage of These Sperm That Were Motile	20	—
SECONDARY Serious and Non-Serious Adverse Effects	1	—

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.

Eligibility Criteria

Inclusion Criteria: Infertile men with azoospermia on at least two semen analyses separated by at least one week, and no pregnancy with partner with normal cycles and normal hysterosalpingogram despite >1 year of unprotected intercourse. - Exclusion Criteria: hypogonadotropic hypogonadism (that might respond to gonadotropin injections); use of anabolic steroids,illicit drugs, or consumption of more than 4 alcoholic beverages daily; current therapy with retinoic acid (eg Accutane) or vitamin A- of use of isotretinoin within eight weeks of start of dosing;phenytoin, or medication containing tetracycline; personal history of serious psychiatric disorders, score of greater than 15 on the PHQ9 (mood) questionnaire; elevated serum serum triglycerides or other abnormal serum chemistry values; history of inflammatory bowel disease or bone disease; not living within catchment area; participation in another clinical trial -

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Data sourced from ClinicalTrials.gov (NCT03323801). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.