RA-2 13-cis Retinoic Acid (Isotretinoin)

Men with infertility and normal hormone levels have few options for fertility treatment. Previous research work has suggested that men with infertility may have low levels of the active form of Vitamin A, called retinoic acid, in their testes. We think that giving men with low sperm counts retinoic acid may increase their sperm counts and improve their chances of fathering a pregnancy. We want to see if retinoic acid administration over twenty weeks can increase sperm production and help infertile men become fathers without the need for In vitro fertilization (IVF) and/or intracytoplasmic sperm injection (ICSI). We also want to see if adding calcitriol with retinoic acid will improve sperm motility in a sub-set of subjects.

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Key information

Conditions

Male Infertility Chromosome Disorders Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Disorders of Sex Development Endocrine System Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genetic Diseases, Inborn Genital Diseases Genital Diseases, Male Gonadal Disorders Hypogonadism Infertility Infertility, Male Klinefelter Syndrome Klinefelter's Syndrome Male Urogenital Diseases Male sterility due to Y-chromosome deletions Sex Chromosome Disorders Sex Chromosome Disorders of Sex Development Urogenital Abnormalities Urogenital Diseases Y-chromosome Microdeletions

Age range

21 year–60 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 2

Primary location

University of Washington Medical Center

Seattle, Washington, 98195, United States

About this study

This is a 20 week, unblinded, two-arm pilot study to determine the impact of therapy with 13-cis retinoic acid and calcitriol on sperm indices in infertile men. Twenty infertile men, ages 21-60 with abnormal sperm analyses will be enrolled for 20-week and given 20 mg 13-cis retinoic acid, twice daily. Subjects#11-#20 will also be administered calcitriol to see if adding calcitriol with Accutane will improve sperm motility. All subjects will be closely followed for side effects related to treatment. The impact of treatment on indices of spermatogenesis will be determined by monthly seminal fluid analyses.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

13-cis retinoic acid

Drug

Accutane is used for the treatment of severe acne

Other names: Accutane, Isotretinoin

calcitriol

Drug

Calcitriol is a form of vitamin D given twice daily (BID)

Other names: 1,25-dihydroxyvitamin D3

Primary outcomes

Millions of Sperm Per Ejaculate

Time frame: Up to 20-weeks

Millions of sperm per ejaculate in men treated with 13-cis retinoic acid

Sponsors and collaborators

Lead sponsor

University of Washington

Other

Registry information

Official study title

A Pilot Trial of 13-cis Retinoic Acid (Isotretinoin) for the Treatment of Men With Oligoasthenoteratozoospermia

Acronym: RA-2

Important dates

Study start: 2014
Primary completion: 2018
Study completion: 2018
First posted: Feb 12, 2014
Registry last updated: Aug 2, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed