13-cis Retinoic Acid (Isotretinoin) and Sperm Production (ARESPERM)

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Men with Infertility
• Intervention / Treatment: Drug: Isotretinoin; Drug: Control group (placebo)

• Study Type: Interventional
• Enrollment (Estimated): 100
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Sarah Hustache; Phone Number: 0388116768; Email: dpidrci@chru-strasbourg.fr
• Study Contact Backup: Name: Marius Teletin, MD; Email: marius.teletin@chru-strasbourg.fr

Study Locations

• France
  • Schiltigheim, France, 67300
    • CECOS Alsace Strasbourg
    • Contact: Marius Teletin, MD; Phone Number: 03 69 55 35 30; Email: marius.teletin@chru-strasbourg.fr
    • Contact: Marius Teletin, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Isotretinoin; Isotretinoin (40 mg) orally, once per week for 20 weeks	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.
Placebo Comparator: control group; Placebo identical in appearance and administration schedule.	Drug: Control group (placebo); placebo administration

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Millions of Sperm Per Ejaculate	Concentration calculation of Millions of sperm per ejaculate in men treated with 13-cis retinoic acid	Day 0
Millions of Sperm Per Ejaculate	Concentration calculation of Millions of sperm per ejaculate in men treated with 13-cis retinoic acid	Months 2
Millions of Sperm Per Ejaculate	Concentration calculation of Millions of sperm per ejaculate in men treated with 13-cis retinoic acid	Months 5
Millions of Sperm Per Ejaculate	Concentration calculation of Millions of sperm per ejaculate in men treated with 13-cis retinoic acid	Months 12
Millions of Sperm Per Ejaculate	Concentration calculation of Millions of sperm per ejaculate in men treated with 13-cis retinoic acid	Months 24

Collaborators and Investigators

• Sponsor: University Hospital, Strasbourg, France

Study record dates

Study Major Dates

• Study Start (Estimated): March 1, 2025
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2027

Study Registration Dates

• First Submitted: November 18, 2024
• First Submitted That Met QC Criteria: November 18, 2024
• First Posted (Actual): November 20, 2024

Study Record Updates

• Last Update Posted (Estimated): November 25, 2024
• Last Update Submitted That Met QC Criteria: November 21, 2024
• Last Verified: November 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urogenital Diseases; Genital Diseases; Infertility; Dermatologic Agents; Isotretinoin
• Other Study ID Numbers: 7345; 2024-519644-33-00 (Ctis)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No