Status:
COMPLETED
RA-4: 13-cis Retinoic Acid for Treatment of Men With Azoospermia
Lead Sponsor:
University of Washington
Collaborating Sponsors:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Conditions:
Male Infertility, Azoospermia
Eligibility:
MALE
21-60 years
Phase:
PHASE2
Brief Summary
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, calle...
Detailed Description
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...
Eligibility Criteria
Inclusion
- 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
- 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
- \-
Key Trial Info
Start Date :
July 25 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 31 2019
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT03323801
Start Date
July 25 2017
End Date
May 31 2019
Last Update
October 26 2021
Active Locations (1)
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1
University of Washington Medical Center
Seattle, Washington, United States, 98195