13-cis Retinoic Acid (Isotretinoin) and Sperm Production

Phase 4

Not yet recruiting

• Conditions: Men with Infertility
• Interventions: Drug: Isotretinoin; Drug: Control group (placebo)

• Registration Number: NCT06698263
• Lead Sponsor: University Hospital, Strasbourg, France

Brief Summary

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 producti...

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Status Verified: 2024-11
• Study First Submitted: 2024-11-18
• Study First Submitted QC: 2024-11-18
• Study First Posted: 2024-11-20
• Last Update Submitted: 2024-11-21
• Last Update Posted: 2024-11-25
• Study Start: 2025-03-01
• Primary Completion: 2027-12-01
• Study Completion: 2027-12-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: Male
• Target Recruitment: 100

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Isotretinoin	Isotretinoin	Isotretinoin (40 mg) orally, once per week for 20 weeks
control group	Control group (placebo)	Placebo identical in appearance and administration schedule.

Primary Outcome Measures

Name	Time	Method
Millions of Sperm Per Ejaculate	Months 24	Concentration calculation of Millions of sperm per ejaculate in men treated with 13-cis retinoic acid

Trial Locations

Locations (1)

CECOS Alsace Strasbourg; 🇫🇷 Schiltigheim, France