This phase 2 pilot trial will investigate the effects of isotretinoin in men with no sperm in their semen. The main outcome to be investigated is the number of motile sperm. This trial is being conducted in Seattle, Washington.
The details
Many infertile men have a condition called azoospermia. This is when the semen sample does not contain any sperm. Research suggests that infertile men are low in the active form of vitamin A, called retinoic acid.Isotretinoin (Accutane) is a drug that is derived from Vitamin A.
One study has shown that men with low sperm count benefit from treatment with Vitamin A. As a result, men with azoospermia may also benefit from Vitamin A.
This trial will investigate the effects of isotretinoin in men with azoospermia.Effectiveness will be measured as the number of motile sperm.
Who are they looking for?
This trial will recruit 20 male patients with infertility, aged between 21 and 60. Participants must have azoospermia and no previous pregnancy with a partner.
Participants cannot be currently taking isotretinoin or vitamin A (in the last 8 weeks). Participants cannot be taking anabolic steroids, illegal drugs or consuming more than four alcoholic beverages per day. Other exclusion criteria include hypogonadotropic hypogonadism, a history of serious psychiatric disorders, inflammatory bowel or bone disease.
How will it work
All patients will receive 20 mg isotretinoin twice a day with meals for 32 weeks. At the end of the trial a semen sample will be collected and analyzed. Side effects will also be monitored.
The main outcome will be the change in the number of motile sperm.
