RA-4: 13-cis Retinoic Acid for Treatment of Men With Azoospermia
| Status: | Recruiting |
|---|---|
| Conditions: | Women's Studies |
| Therapuetic Areas: | Reproductive |
| Healthy: | No |
| Age Range: | 21 - 60 |
| Updated: | 10/14/2018 |
| Start Date: | July 25, 2017 |
| End Date: | December 31, 2019 |
| Contact: | Iris Nielsen |
| Email: | nielseni@uw.edu |
| Phone: | 206-221-5473 |
A Pilot Trial of 13-cis Retinoic Acid (Isotretinoin) for the 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.
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.
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.
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
hysterosalpinogogram 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 tetracyline; 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
We found this trial at
1
site
1959 NE Pacific St
Seattle, Washington 98195
Seattle, Washington 98195
(206) 598-3300
Principal Investigator: John K Amory, MD, MPH
Phone: 206-221-5473
University of Washington Medical Center University of Washington Medical Center is one of the nation's...
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