13-cis Retinoic Acid (Isotretinoin) and Sperm Production
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Isotretinoin, Control group (placebo).
- Who it may be relevant to
- Registry conditions: Men with Infertility. Basic parameters: 21 years — 55 years · Male.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- France
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Interventions
- 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
Primary outcome measures
- Millions of Sperm Per Ejaculate [Time frame: Day 0]
- Millions of Sperm Per Ejaculate [Time frame: Months 2]
- Millions of Sperm Per Ejaculate [Time frame: Months 5]
- Millions of Sperm Per Ejaculate [Time frame: Months 12]
- Millions of Sperm Per Ejaculate [Time frame: Months 24]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Triple blind
- Primary purpose
- Treatment
Study locations
France · 1 center
- CECOS Alsace Strasbourg — Schiltigheim
Identifiers
NCT: NCT06698263 · 7345 · 2024-519644-33-00