NCT03323801

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

Completed Phase 2 Results posted Last updated 26 October 2021

What this trial tests

Phase 2 trial testing 13-cis retinoic acid in Male Infertility, Azoospermia in 10 participants. Completed in 31 May 2019.

Timeline

25 July 2017

Primary endpoint
16 May 2019

31 May 2019

Quick facts

Lead sponsor	University of Washington
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	10
Start date	25 July 2017
Primary completion	16 May 2019
Estimated completion	31 May 2019
Sites	1 location across United States

Drugs / interventions tested

• 13-cis retinoic acid — full drug profile →

Conditions studied

• Male Infertility, Azoospermia — all drugs for Male Infertility, Azoospermia →

Sponsor

University of Washington

Who can join

Adults 21 to 60, male only, with Male Infertility, Azoospermia. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Total Motile Sperm Primary · up to 32 weeks

Number of participants with undetectable or detectable sperm in their ejaculates.

undetectable

Group	Value	95% CI
Accutane-13-cis Retinoic Acid	8

detectable motile sperm

Group	Value	95% CI
Accutane-13-cis Retinoic Acid	1

Total Sperm and Percentage of These Sperm That Were Motile Primary · 32 weeks

Number of total sperm in ejaculate and percentage of these sperm that were motile

Group	Value	95% CI
13-cis Retinoic Acid	20

Serious and Non-Serious Adverse Effects Secondary · 32 weeks

Number of participants with Serious and Non-Serious Adverse effects associated with treatment with 13-cis retinoic acid

Group	Value	95% CI
Accutane-13-cis Retinoic Acid	1

Adverse events — posted to ClinicalTrials.gov

Time frame: 32 weeks. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Accutane-13-cis Retinoic Acid

Serious: 1/10 (10%)

Deaths: 0/10

Serious adverse events (1 terms)

Reaction	System	Accutane-13-cis Retinoic A…
nephrotic syndrome	Gastrointestinal disorders	—

Other adverse events (1 terms — click to expand)

Reaction	System	Accutane-13-cis Retinoic A…
cramps	Musculoskeletal and connective tissue disorders	—

Most-reported serious reactions: nephrotic syndrome.

Data from ClinicalTrials.gov NCT03323801 adverse events section.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Retinoids as Chemo-Preventive and Molecular-Targeted Anti-Cancer Therapies.
   Hunsu VO, Facey COB, Fields JZ, Boman BM. · · 2021 · cited 62× · PMID 34299349 · DOI 10.3390/ijms22147731