13-cis Retinoic Acid (Isotretinoin) and Sperm Production

Launched by UNIVERSITY HOSPITAL, STRASBOURG, FRANCE · Nov 18, 2024

Keywords

ClinConnect Summary

This clinical trial is studying whether a medication called isotretinoin, taken once a week, can help increase sperm production in men who have a low sperm count, a condition known as oligozoospermia. The trial will involve men aged 21-55 who have been trying to conceive with their partners for over a year without success, despite normal reproductive health tests. Participants will be divided into two groups: one will receive isotretinoin, and the other will receive a placebo (a dummy treatment that looks like the real medication but has no active ingredients). The main goal is to see how sperm production changes over 20 weeks of treatment.

To be eligible for the trial, men must have a sperm count of less than 10 million sperm and should not be currently participating in any other clinical studies. They should also not have certain medical conditions that could affect the results, such as specific genetic issues or severe mental health problems. Participants will be closely monitored throughout the study and will need to provide informed consent before starting. It's important to note that this trial is not yet recruiting participants, so interested individuals will need to wait for further announcements about enrollment.

Gender

MALE

Eligibility criteria

• 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