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RA-4: 13-cis Retinoic Acid for Treatment of Men With Azoospermia

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT03323801
Recruitment Status : Completed
First Posted : October 27, 2017
Last Update Posted : June 27, 2019
Information provided by (Responsible Party):
John Amory, University of Washington

Tracking Information
First Submitted Date  ICMJE October 24, 2017
First Posted Date  ICMJE October 27, 2017
Last Update Posted Date June 27, 2019
Actual Study Start Date  ICMJE July 25, 2017
Actual Primary Completion Date May 16, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 24, 2017)
Total motile sperm [ Time Frame: up to 32 weeks ]
Total motile sperm in azoospermic men treated with 13-cis retinoic acid
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03323801 on Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: October 24, 2017)
  • 13-cis retinoic acid serum level [ Time Frame: 32 weeks ]
    concentration level of 13-cis retinoic acid in the serum of treatment men
  • Serious and Non-Serious adverse effects [ Time Frame: 32 weeks ]
    Number of participants with Serious and Non-Serious Adverse effects associated with treatment with 13-cis retinoic acid
  • 13-cis retinoic acid Seminal Plasma concentration [ Time Frame: up to 32 weeks ]
    13-cis retinoic acid concentration in semen of treated men
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
Descriptive Information
Brief Title  ICMJE RA-4: 13-cis Retinoic Acid for Treatment of Men With Azoospermia
Official Title  ICMJE A Pilot Trial of 13-cis Retinoic Acid (Isotretinoin) for the Treatment of Men With Azoospermia
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Intervention Model: Single Group Assignment
Intervention Model Description:
20 mg 13-cis retinoic acid twice daily (BID) with meals for 32 weeks
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Male Infertility, Azoospermia
Intervention  ICMJE Drug: 13-cis retinoic acid
Accutane is used for the treatment of severe acne
Other Name: Accutane, Isotretinoin
Study Arms  ICMJE Experimental: 13-cis retinoic acid
20 mg 13-cis retinoic acid twice daily (BID) with means for 32 weeks
Intervention: Drug: 13-cis retinoic acid
Publications *

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: June 25, 2019)
Original Estimated Enrollment  ICMJE
 (submitted: October 24, 2017)
Actual Study Completion Date  ICMJE May 31, 2019
Actual Primary Completion Date May 16, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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


Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE 21 Years to 60 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
Administrative Information
NCT Number  ICMJE NCT03323801
Other Study ID Numbers  ICMJE STUDY00001055
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party John Amory, University of Washington
Study Sponsor  ICMJE University of Washington
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: John K Amory, MD University of Washington
PRS Account University of Washington
Verification Date June 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP