NCT02061384

RA-2 13-cis Retinoic Acid (Isotretinoin)

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: University of Washington · Academic / Other
• Sex: Male
• Age: 21 Years – 60 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Male Infertility
• Klinefelter's Syndrome
• Y-chromosome Microdeletions

Interventions

Type	Name	Description
DRUG	13-cis retinoic acid	Accutane is used for the treatment of severe acne
DRUG	Calcitriol	Calcitriol is a form of vitamin D given twice daily (BID)

Timeline

• Start date: 2014-08-01
• Primary completion: 2018-12-01
• Completion: 2018-12-01
• First posted: 2014-02-12
• Last updated: 2021-08-02
• Results posted: 2021-07-30

Locations

1 site across 1 country: United States