13-cis Retinoic Acid (Isotretinoin) and Sperm Production

13-cis Retinoic Acid (Isotretinoin) and Sperm Production

This study aims to evaluate the effectiveness of weekly administration of isotretinoin (40 mg) in increasing sperm production in men with oligozoospermia, a condition characterized by a low sperm count. Participants will be randomized into two groups: one receiving isotretinoin and the other a placebo. The primary outcome will be the change in sperm production over 20 weeks of treatment.

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.
• Male patients aged 21-55 years
• Affiliation with a social security system
• Ability to provide informed consent

Exclusion Criteria:

• -Men participating in another clinical trial
• 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),
• Severe mental health problems requiring medications
• Current therapy with retinoic acid (e.g. Accutane) or vitamin A.
• History of psychiatric disorders (e.g., depression, suicidal tendencies).
• Abnormal serum chemistry values according to local laboratory normal values which indicate liver or kidney dysfunction.
• Men currently receiving tetracycline containing medications
• Men who have used isotretinoin within eight weeks of the start of dosing
• Men with elevated serum triglycerides