Efficacy of Isotretinoin on Sperm Production in Men with Oligozoospermia
- Trial ID
- 2024-519644-33-00
- Protocol
- 7345
Trial statistics
Diseases & Conditions
Objectives
The primary objective is to evaluate the efficacy of isotretinoin regarding sperm production in patients diagnosed with oligozoospermia. The secondary objective is to assess sperm motility and sperm morphology in individuals receiving the active treatment compared to those receiving a placebo. 5
Participants
The sponsor did not provide the total number of participants for this study. The study population consists of males between the ages of 21 and 55 years diagnosed with oligozoospermia. This condition is defined by a concentration of fewer than 15 million spermatozoa per ml or fewer than 39 million spermatozoa per ejaculate, which must be confirmed by two separate semen analyses performed at least one month apart within the preceding 12 months. Eligible participants must have experienced infertility for a duration exceeding 12 months. All subjects are required to be affiliated with a health insurance scheme.
Plans and Procedures
This Phase III clinical trial is designed to evaluate the effectiveness of isotretinoin on sperm production in men diagnosed with oligozoospermia. The study utilizes a placebo-controlled methodology to compare the impact of 40 mg isotretinoin soft capsules against 260 mg placebo tablets administered orally. The primary endpoint is the assessment of sperm production following 20 weeks of weekly treatment. Secondary endpoints include the evaluation of sperm motility and morphology after the same period. The protocol involves an initial screening visit to confirm eligibility based on specific diagnostic criteria, followed by the treatment period and subsequent evaluations to monitor clinical outcomes. The expected duration of participant involvement is at least 20 weeks of treatment.
Treatment
The experimental treatment consists of isotretinoin administered in the form of a 40 mg soft capsule. The medication is intended for oral administration.
The control group receives a 260 mg placebo in tablet form.
Efficacy
The primary efficacy endpoint is sperm production, which is evaluated following 20 weeks of weekly administration of isotretinoin. This parameter is compared against the results obtained from the placebo group.
Secondary efficacy endpoints include the assessment of sperm motility and sperm morphology at the 20-week mark following the weekly treatment period.
Inclusion and Exclusion Criteria
Inclusion Criteria
- Male aged between 21 and 55 years (inclusive)
- Diagnosed with oligozoospermia [fewer than 15 million spermatozoa per ml, fewer than 39 million per ejaculate], confirmed by two separate semen analyses performed at least one month apart and conducted prior to the inclusion visit (within the 12 months preceding inclusion), as part of routine care
- Infertility lasting more than 12 months
- Patient affiliated with or benefiting from a health insurance scheme
- Patient able to understand the objectives and risks of the study and provide dated and signed informed consent
- Patient informed of the results of the preliminary medical examination
Exclusion Criteria
- Known genetic cause of infertility (e.g., chromosomal abnormalities)
- Patient with hypogonadotropic hypogonadism
- Any other clinically significant comorbid condition interfering with spermatogenesis
- Hypersensitivity to isotretinoin or any of its excipients
- Known hyperlipidemia defined by elevated triglycerides >1 g/L
- Known hypervitaminosis A defined by levels >800 µg
- Known allergy to peanut oil, soybean oil, or magnesium stearate
- Ongoing treatment with other retinoids (e.g., acitretin, alitretinoin)
- Ongoing treatment interfering with spermatogenesis and/or vitamin A metabolism (e.g., tetracyclines, rifampicin, phenytoin, phenobarbital, antiretrovirals, or other CYP enzyme inducers)
- Current treatment with vitamin A
- Known hepatic insufficiency, defined by ASAT/ALAT >2x upper limit of normal at the inclusion visit
- Known severe renal insufficiency, defined by albuminuria and/or abnormal blood creatinine levels at the inclusion visit
- History of severe allergic or anaphylactic reactions
- Known psychiatric disorder (e.g., depression, psychotic symptoms, mood changes), defined by an MDI score >15 at inclusion
- Known history of suicide attempts or known suicide risk
- Surgery of the genitourinary tract in the year preceding inclusion
- Prior treatment with isotretinoin (e.g., Acnetrait, Contracné, Curacné, Procuta) within the 3 months prior to the inclusion visit
- Tobacco use (more than 5 cigarettes per day)
- Chronic alcohol consumption
- Use of systemic medication within the 3 months prior to inclusion
- Patient informed of and consenting not to donate blood during treatment and for 1 month after its completion
- Patient currently in an exclusion period (as determined by a previous or ongoing study)
- Patient under legal guardianship or curatorship
- Patient under judicial protection
- Inability to provide informed consent (e.g., emergency situations, comprehension difficulties, language barriers, etc.)
Trial Status by Country
| Country | Status | Start of Recruitment | Planned Patients |
|---|---|---|---|
 France | Not Yet Recruiting | 01 Jan 2026 | 100 |
Sites & Investigators
Investigational Products
Details about the medicinal products being studied in this clinical trial.
| Product Name | Role in Trial | Formulation | Administration | Max Daily Dose | Treatment Duration | EU MP Number |
|---|---|---|---|---|---|---|
comprimés placebo à usage thérapeutique 260mg | Placebo | N/A | — | — | — | N/A |
ISOTRETINOINE ACNETRAIT 40 mg, capsule molle | Test | CAPSULE | ORAL | 40 | 20 | PRD12935269 |