At a glance
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A Pilot Trial of 13-cis Retinoic Acid (Isotretinoin) for the Treatment of Men With Oligoasthenoteratozoospermia
In Brief
A Phase 2 clinical trial evaluating 13-cis retinoic acid and Calcitriol for Male Infertility and 2 related conditions. Completed, enrolled 20 participants across 1 site.
Detailed 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.
Study Details
Timeline
Interventions
Accutane is used for the treatment of severe acne
Calcitriol is a form of vitamin D given twice daily (BID)