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Completed

NCT Number: NCT03323801

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

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.

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Key information

Conditions

Male Infertility, Azoospermia Azoospermia Genital Diseases Genital Diseases, Male Infertility Infertility, Male Male Urogenital Diseases Urogenital Diseases

Age range

21 year–60 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 2

Primary location

University of Washington Medical Center

Seattle, Washington, 98195, United States

About this study

Twenty men with infertility, aged 21 - 60, due to azoospermia (no apparent sperm in the ejaculate on two separate occasions) will be enrolled in a single-arm pilot trial of daily oral therapy of 20 mg twice daily of 13-cis retinoic acid for 32 weeks. The impact of treatment on the appearance of sperm in the ejaculate will be determined by monthly semen analyses.

Note: The outcome measure of serum and seminal plasma 13-cis-retinoic acid concentrations was entered in error and not intended to be reported for this study. Information on these levels is available in our earlier study of 13-cis-retinoic acid in men with sub-fertility. Amory et al. Andrology 2017 5:1115-1123.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

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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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Treatment and study plan

13-cis retinoic acid

Drug

Accutane is used for the treatment of severe acne

Other names: Accutane, Isotretinoin

Primary outcomes

  1. Total Motile Sperm

    Time frame: up to 32 weeks

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

  2. Total Sperm and Percentage of These Sperm That Were Motile

    Time frame: 32 weeks

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

Secondary outcomes

  1. Serious and Non-Serious Adverse Effects

    Time frame: 32 weeks

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

Sponsors and collaborators

Lead sponsor

University of Washington

Other

Collaborators

  • Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Oct 27, 2017
Registry last updated
Oct 26, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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