Back to resultsRA-4: 13-cis Retinoic Acid for Treatment of Men With Azoospermia
Primary Purpose
Male Infertility, Azoospermia
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
13-cis retinoic acid
Sponsored by
About this trial
This is an interventional treatment trial for Male Infertility, Azoospermia focused on measuring Infertility
Eligibility Criteria
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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Sites / Locations
- University of Washington Medical Center
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
13-cis retinoic acid
Arm Description
20 mg 13-cis retinoic acid twice daily (BID) with means for 32 weeks
Outcomes
Primary Outcome Measures
Total Motile Sperm
Number of participants with undetectable or detectable sperm in their ejaculates.
Total Sperm and Percentage of These Sperm That Were Motile
Number of total sperm in ejaculate and percentage of these sperm that were motile
Secondary Outcome Measures
Serious and Non-Serious Adverse Effects
Number of participants with Serious and Non-Serious Adverse effects associated with treatment with 13-cis retinoic acid
Full Information
NCT ID
NCT03323801
First Posted
October 24, 2017
Last Updated
September 27, 2021
Sponsor
University of Washington
Collaborators
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
1. Study Identification
Unique Protocol Identification Number
NCT03323801
Brief Title
RA-4: 13-cis Retinoic Acid for Treatment of Men With Azoospermia
Official Title
A Pilot Trial of 13-cis Retinoic Acid (Isotretinoin) for the Treatment of Men With Azoospermia
Study Type
Interventional
2. Study Status
Record Verification Date
September 2021
Overall Recruitment Status
Completed
Study Start Date
July 25, 2017 (Actual)
Primary Completion Date
May 16, 2019 (Actual)
Study Completion Date
May 31, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Washington
Collaborators
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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, 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.
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 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Male Infertility, Azoospermia
Keywords
Infertility
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Model Description
20 mg 13-cis retinoic acid twice daily (BID) with meals for 32 weeks
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Actual)
8. Arms, Groups, and Interventions
Arm Title
13-cis retinoic acid
Arm Type
Experimental
Arm Description
20 mg 13-cis retinoic acid twice daily (BID) with means for 32 weeks
Intervention Type
Drug
Intervention Name(s)
13-cis retinoic acid
Other Intervention Name(s)
Accutane, Isotretinoin
Intervention Description
Accutane is used for the treatment of severe acne
Primary Outcome Measure Information:
Title
Total Motile Sperm
Description
Number of participants with undetectable or detectable sperm in their ejaculates.
Time Frame
up to 32 weeks
Title
Total Sperm and Percentage of These Sperm That Were Motile
Description
Number of total sperm in ejaculate and percentage of these sperm that were motile
Time Frame
32 weeks
Secondary Outcome Measure Information:
Title
Serious and Non-Serious Adverse Effects
Description
Number of participants with Serious and Non-Serious Adverse effects associated with treatment with 13-cis retinoic acid
Time Frame
32 weeks
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
-
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
John K Amory, MD
Organizational Affiliation
University of Washington
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Washington Medical Center
City
Seattle
State/Province
Washington
ZIP/Postal Code
98195
Country
United States
12. IPD Sharing Statement
Citations:
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8102079
Citation
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Links:
URL
http://www.cdc.gov/nchs/fastats/fertile.htm
Description
Center for Disease Control, Infertility Facts, on June 3rd, 2013
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RA-4: 13-cis Retinoic Acid for Treatment of Men With Azoospermia
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