Male Infertility, Azoospermia Clinical Trial
Official title:
A Pilot Trial of 13-cis Retinoic Acid (Isotretinoin) for the Treatment of Men With Azoospermia
| Verified date | September 2021 |
| Source | University of Washington |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 10 |
| Est. completion date | May 31, 2019 |
| Est. primary completion date | May 16, 2019 |
| Accepts healthy volunteers | No |
| Gender | Male |
| Age group | 21 Years to 60 Years |
| Eligibility | 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 - |
| Country | Name | City | State |
|---|---|---|---|
| United States | University of Washington Medical Center | Seattle | Washington |
| Lead Sponsor | Collaborator |
|---|---|
| University of Washington | Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) |
United States,
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| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Total Motile Sperm | Number of participants with undetectable or detectable sperm in their ejaculates. | up to 32 weeks | |
| Primary | Total Sperm and Percentage of These Sperm That Were Motile | Number of total sperm in ejaculate and percentage of these sperm that were motile | 32 weeks | |
| Secondary | Serious and Non-Serious Adverse Effects | Number of participants with Serious and Non-Serious Adverse effects associated with treatment with 13-cis retinoic acid | 32 weeks |