ISOTRETINOIN for Oligozoospermia

Inclusion criteria

• {"criterion_text":"- Male aged between 21 and 55 years (inclusive)"}
• {"criterion_text":"- 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"}
• {"criterion_text":"- Infertility lasting more than 12 months"}
• {"criterion_text":"- Patient affiliated with or benefiting from a health insurance scheme"}
• {"criterion_text":"- Patient able to understand the objectives and risks of the study and provide dated and signed informed consent"}
• {"criterion_text":"- Patient informed of the results of the preliminary medical examination"}

Exclusion criteria

• {"criterion_text":"- Known genetic cause of infertility (e.g., chromosomal abnormalities)"}
• {"criterion_text":"- Current treatment with vitamin A"}
• {"criterion_text":"- Known hepatic insufficiency, defined by ASAT/ALAT >2x upper limit of normal at the inclusion visit"}
• {"criterion_text":"- Known severe renal insufficiency, defined by albuminuria and/or abnormal blood creatinine levels at the inclusion visit"}
• {"criterion_text":"- History of severe allergic or anaphylactic reactions"}
• {"criterion_text":"- Known psychiatric disorder (e.g., depression, psychotic symptoms, mood changes), defined by an MDI score >15 at inclusion"}
• {"criterion_text":"- Known history of suicide attempts or known suicide risk"}
• {"criterion_text":"- Surgery of the genitourinary tract in the year preceding inclusion"}
• {"criterion_text":"- Prior treatment with isotretinoin (e.g., Acnetrait, Contracné, Curacné, Procuta) within the 3 months prior to the inclusion visit"}
• {"criterion_text":"- Tobacco use (more than 5 cigarettes per day)"}
• {"criterion_text":"- Chronic alcohol consumption"}
• {"criterion_text":"- Patient with hypogonadotropic hypogonadism"}
• {"criterion_text":"- Use of systemic medication within the 3 months prior to inclusion"}
• {"criterion_text":"- Patient informed of and consenting not to donate blood during treatment and for 1 month after its completion"}
• {"criterion_text":"- Patient currently in an exclusion period (as determined by a previous or ongoing study)"}
• {"criterion_text":"- Patient under legal guardianship or curatorship"}
• {"criterion_text":"- Patient under judicial protection"}
• {"criterion_text":"- Inability to provide informed consent (e.g., emergency situations, comprehension difficulties, language barriers, etc.)"}
• {"criterion_text":"- Any other clinically significant comorbid condition interfering with spermatogenesis"}
• {"criterion_text":"- Hypersensitivity to isotretinoin or any of its excipients"}
• {"criterion_text":"- Known hyperlipidemia defined by elevated triglycerides >1 g/L"}
• {"criterion_text":"- Known hypervitaminosis A defined by levels >800 µg"}
• {"criterion_text":"- Known allergy to peanut oil, soybean oil, or magnesium stearate"}
• {"criterion_text":"- Ongoing treatment with other retinoids (e.g., acitretin, alitretinoin)"}
• {"criterion_text":"- Ongoing treatment interfering with spermatogenesis and/or vitamin A metabolism (e.g., tetracyclines, rifampicin, phenytoin, phenobarbital, antiretrovirals, or other CYP enzyme inducers)"}

Primary endpoints

• {"endpoint_text":"- The primary evaluation criterion is sperm production measured after 20 weeks of weekly isotretinoin treatment, compared to that of men who received a placebo","definition_or_measurement_approach":"Sperm production measured after 20 weeks of weekly isotretinoin treatment compared with placebo (measurement at 20 weeks following weekly dosing)."}

Secondary endpoints

• {"endpoint_text":"- Sperm motility and morphology after 20 weeks of weekly isotretinoin treatment","definition_or_measurement_approach":"Assessment of sperm motility and sperm morphology after 20 weeks of weekly isotretinoin treatment."}

France

Earliest CTIS Part Ii Submission Date

20-03-2026

Latest Decision Or Authorization Date

09-04-2026

Processing Time Days

20

Number Of Sites

3

Number Of Participants

100

Primary sponsor

Full Name

Les Hopitaux Universitaires De Strasbourg

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

France