RA-2 13-cis Retinoic Acid (Isotretinoin) (RA-2)
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ClinicalTrials.gov Identifier: NCT02061384 |
Recruitment Status
:
Active, not recruiting
First Posted
: February 12, 2014
Last Update Posted
: May 30, 2017
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Condition or disease | Intervention/treatment | Phase |
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Male Infertility Klinefelter's Syndrome Y-chromosome Microdeletions | Drug: 13-cis retinoic acid Drug: Calcitriol | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 20 participants |
Allocation: | Non-Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | A Pilot Trial of 13-cis Retinoic Acid (Isotretinoin) for the Treatment of Men With Oligoasthenoteratozoospermia |
Study Start Date : | August 2014 |
Estimated Primary Completion Date : | December 2017 |
Estimated Study Completion Date : | December 2018 |

Arm | Intervention/treatment |
---|---|
Experimental: 13-cis retinoic acid
20mg 13-cis retinoic acid twice daily (BID) with meals for 20 weeks
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Drug: 13-cis retinoic acid
Accutane is used for the treatment of severe acne
Other Names:
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Experimental: Calcitriol 0.25 mcg
oral calcitriol 025 mcg BID subjects 11-20 for 20 weeks
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Drug: Calcitriol
Calcitriol is a form of vitamin D given twice daily (BID)
Other Name: 1,25-dihydroxyvitamin D3
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- Total motile sperm [ Time Frame: Up to 20-weeks ]Total motile sperm count in men treated with 13-cis retinoic acid
- 13-cis retinoic acid serum level [ Time Frame: 20-weeks ]Concentration level of 13-cis retinoic acid in the serum of treated men
- Number of Participants with Serious and Non-Serious Adverse effects associated with treatment with 13-cis retinoic acid [ Time Frame: 20-weeks ]Number of adverse effects per subject associated with treatment with 13-cis retinoic acid
- 13-cis retinoic acid Seminal Plasma Concentration [ Time Frame: Up to 20-weeks ]13-cis retinoic acid concentration in semen of treated men
- To determine if the additions of calcitriol with 13-cis retinoic acid can improve sperm motility [ Time Frame: 20 weeks ]improved sperm motility

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Ages Eligible for Study: | 21 Years to 60 Years (Adult) |
Sexes Eligible for Study: | Male |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Subjects will be infertile men (no pregnancy with partner with normal cycles and normal hysterosalpingogram despite >1 year of unprotected intercourse).
- Abnormal sperm analyses with a total, motile sperm count of less than 10 million sperm as assessed by semen analysis on two occasions separated by one week.
- In the opinion of the investigator, is able to comply with the protocol, understand and sign an informed consent and HIPAA (Health Insurance Portability and Accountability Act ) form.
Exclusion Criteria:
- Men participating in another clinical trial
- Men not living in the catchment area of the clinic
- Clinically significant abnormal findings at screening
- Known genetic infertility (e.g. Klinefelter syndrome or Y-chromosome microdeletions),
- Hypogonadotropic hypogonadism (that might respond to gonadotropin injections),
- The use of anabolic steroids, illicit drugs, or the consumption of more than 4 alcoholic beverages daily
- Severe mental health problems requiring medications
- Current therapy with retinoic acid (e.g. Accutane) or vitamin A.
- Score of greater than 15 on the Patient health questionnaire (PHQ9).
- Abnormal serum chemistry values according to local laboratory normal values which indicate liver or kidney dysfunction. Other abnormal lab values may also be exclusionary, at the discretion of the investigator
- Men with a personal history of serious psychiatric disorders
- Men currently receiving tetracycline containing medications
- Men currently receiving phenytoin
- Men with a history of inflammatory bowel disease
- Men with a history of bone disease
- Men who have used isotretinoin within eight weeks of the start of dosing
- Men with elevated serum triglycerides

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): NCT02061384
United States, Washington | |
University of Washington Medical Center | |
Seattle, Washington, United States, 98195 |
Principal Investigator: | John K Amory, MD, MPH | University of Washington |
Publications:
Responsible Party: | John Amory, Professor, General Internal Medicine, University of Washington |
ClinicalTrials.gov Identifier: | NCT02061384 History of Changes |
Other Study ID Numbers: |
STUDY00000564 |
First Posted: | February 12, 2014 Key Record Dates |
Last Update Posted: | May 30, 2017 |
Last Verified: | May 2017 |
Keywords provided by John Amory, University of Washington:
Infertility |
Additional relevant MeSH terms:
Klinefelter Syndrome Infertility Infertility, Male Chromosome Deletion Sex Chromosome Aberrations Sex Chromosome Disorders of Sex Development Genital Diseases, Male Genital Diseases, Female Disorders of Sex Development Urogenital Abnormalities Sex Chromosome Disorders Chromosome Disorders Congenital Abnormalities Genetic Diseases, Inborn Gonadal Disorders |
Endocrine System Diseases Hypogonadism Monosomy Aneuploidy Chromosome Aberrations Pathologic Processes Calcitriol Dihydroxycholecalciferols Tretinoin Isotretinoin Calcium Channel Agonists Membrane Transport Modulators Molecular Mechanisms of Pharmacological Action Vasoconstrictor Agents Vitamins |