NCT06698263

13-cis Retinoic Acid (Isotretinoin) and Sperm Production

• Status: Not Yet Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: University Hospital, Strasbourg, France · Academic / Other
• Sex: Male
• Age: 21 Years – 55 Years
• Healthy volunteers: Not accepted

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 production over 20 weeks of treatment.

Conditions

• Men with Infertility

Interventions

Type	Name	Description
DRUG	Isotretinoin	ARESPERM is a multicenter, randomized, double-blind, placebo-controlled study that assesses whether a weekly dose of isotretinoin can stimulate spermatogenesis in men with oligozoospermia. The study hypothesizes that isotretinoin can trigger the differentiation of spermatogonial cells, leading to improved sperm production.
DRUG	Control group (placebo)	placebo administration

Timeline

• Start date: 2025-03-01
• Primary completion: 2027-12-01
• Completion: 2027-12-01
• First posted: 2024-11-20
• Last updated: 2024-11-25

Locations

1 site across 1 country: France