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Retinoic acid and sperm production in infertile men
EU CTIS ID: 2024-519644-33-00
What this study is testing
To evaluate, in terms of sperm production, the effectiveness of treatment with isotretinoin in patients with oligozoospermia.
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 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
You likely can't join if
- Known genetic cause of infertility (e.g., chromosomal abnormalities)
- 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
See the full eligibility 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
- Known genetic cause of infertility (e.g., chromosomal abnormalities)
- 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
- Patient with hypogonadotropic hypogonadism
- 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.)
- 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)
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling male, 18-64 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.