A Phase 2 interventional study of 13-cis retinoic acid in Male Infertility, Azoospermia, sponsored by University of Washington. Completed at 1 site in United States. Open to male participants aged 21 Years to 60 Years. Per ClinicalTrials.gov, last updated 2021-10-26.
Sponsored by University of Washington · Phase 2, Interventional, and Treatment
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.
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.
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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20 mg 13-cis retinoic acid twice daily (BID) with means for 32 weeks
Drug: 13-cis retinoic acid
Accutane is used for the treatment of severe acne
Also known as: Accutane, Isotretinoin
Total Motile Sperm
Number of participants with undetectable or detectable sperm in their ejaculates.
Time frame: up to 32 weeks
Total Sperm and Percentage of These Sperm That Were Motile
Number of total sperm in ejaculate and percentage of these sperm that were motile
Time frame: 32 weeks
Serious and Non-Serious Adverse Effects
Number of participants with Serious and Non-Serious Adverse effects associated with treatment with 13-cis retinoic acid
Time frame: 32 weeks
| Milestone | 13-cis Retinoic Acid |
|---|---|
| Started | 10 |
| Completed | 10 |
| Not completed | 0 |
Number of participants with undetectable or detectable sperm in their ejaculates.
| Participants | Accutane-13-cis Retinoic Acid |
|---|---|
| undetectable | 8 |
| detectable motile sperm | 1 |
Number of total sperm in ejaculate and percentage of these sperm that were motile
| Percent of sperm that were motile | 13-cis Retinoic Acid |
|---|---|
| Total Sperm and Percentage of These Sperm That Were Motile | 20 |
Number of participants with Serious and Non-Serious Adverse effects associated with treatment with 13-cis retinoic acid
| Participants | Accutane-13-cis Retinoic Acid |
|---|---|
| Serious and Non-Serious Adverse Effects | 1 |
Collected over 32 weeks. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Accutane-13-cis Retinoic Acid | 0/10 (0%) | 1/10 (10%) | 1/10 (10%) |
| Event | Accutane-13-cis Retinoic Acid |
|---|---|
| nephrotic syndromeGastrointestinal disorders | 1/10 |
| Event | Accutane-13-cis Retinoic Acid |
|---|---|
| crampsMusculoskeletal and connective tissue disorders | 1/10 |
Men with infertility due to azoospermia
| Age, Categorical(Participants) | 13-cis Retinoic Acid |
|---|---|
| <=18 years | 0 |
| Between 18 and 65 years | 10 |
| >=65 years | 0 |
| Age, Continuous(years) | 13-cis Retinoic Acid |
|---|---|
| Median | 36 (31 to 42) |
| Sex: Female, Male(Participants) | 13-cis Retinoic Acid |
|---|---|
| Female | 0 |
| Male | 10 |
| Ethnicity (NIH/OMB)(Participants) | 13-cis Retinoic Acid |
|---|---|
| Hispanic or Latino | 2 |
| Not Hispanic or Latino | 8 |
| Unknown or Not Reported | 0 |
| Race (NIH/OMB)(Participants) | 13-cis Retinoic Acid |
|---|---|
| American Indian or Alaska Native | 0 |
| Asian | 2 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 0 |
| White | 8 |
| More than one race | 0 |
| Unknown or Not Reported | 0 |
| Region of Enrollment(participants) | 13-cis Retinoic Acid |
|---|---|
| United States | 10 |
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