Men with Infertility
Conditions
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 production over 20 weeks of treatment.
Interventions
DRUGIsotretinoin
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 administration
Sponsors
University Hospital, Strasbourg, France
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
MALE
Age
21 Years to 55 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Millions of Sperm Per Ejaculate | Day 0 | Concentration calculation of Millions of sperm per ejaculate in men treated with 13-cis retinoic acid |
Countries
France
Contacts
Primary ContactSarah Hustache
Backup ContactMarius Teletin, MD
Outcome results
None listed