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

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ClinicalTrials.gov Identifier: NCT03323801
Recruitment Status : Completed
First Posted : October 27, 2017
Last Update Posted : June 27, 2019
Sponsor:
Information provided by (Responsible Party):
John Amory, University of Washington

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.

Condition or disease Intervention/treatment Phase
Male Infertility, Azoospermia Drug: 13-cis retinoic acid Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 10 participants
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
Official Title: A Pilot Trial of 13-cis Retinoic Acid (Isotretinoin) for the Treatment of Men With Azoospermia
Actual Study Start Date : July 25, 2017
Actual Primary Completion Date : May 16, 2019
Actual Study Completion Date : May 31, 2019


Arm Intervention/treatment
Experimental: 13-cis retinoic acid
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
Other Name: Accutane, Isotretinoin




Primary Outcome Measures :
  1. Total motile sperm [ Time Frame: up to 32 weeks ]
    Total motile sperm in azoospermic men treated with 13-cis retinoic acid


Secondary Outcome Measures :
  1. 13-cis retinoic acid serum level [ Time Frame: 32 weeks ]
    concentration level of 13-cis retinoic acid in the serum of treatment men

  2. 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

  3. 13-cis retinoic acid Seminal Plasma concentration [ Time Frame: up to 32 weeks ]
    13-cis retinoic acid concentration in semen of treated men



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Ages Eligible for Study:   21 Years to 60 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03323801


Locations
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United States, Washington
University of Washington Medical Center
Seattle, Washington, United States, 98195
Sponsors and Collaborators
University of Washington
Investigators
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Principal Investigator: John K Amory, MD University of Washington

Additional Information:
Publications:

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Responsible Party: John Amory, Professor, School of Medicine, General Internal Medicine, University of Washington
ClinicalTrials.gov Identifier: NCT03323801     History of Changes
Other Study ID Numbers: STUDY00001055
First Posted: October 27, 2017    Key Record Dates
Last Update Posted: June 27, 2019
Last Verified: June 2019

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by John Amory, University of Washington:
Infertility
Additional relevant MeSH terms:
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Infertility
Infertility, Male
Azoospermia
Genital Diseases, Male
Genital Diseases, Female
Tretinoin
Isotretinoin
Antineoplastic Agents
Keratolytic Agents
Dermatologic Agents