Retinoic acid and sperm production in infertile men

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Les Hopitaux Universitaires De Strasbourg

Participant type

Patients

Age range

18-64 years

Gender

Male

Therapeutic area

Not possible to specify

Decision date (initial)

2026-04-09

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

No

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Efficacy

To evaluate, in terms of sperm production, the effectiveness of treatment with isotretinoin in patients with oligozoospermia.

Secondary objectives 1

1. To evaluate sperm motility and sperm morphology in patients treated with isotretinoin compared to those receiving a placebo.

Conditions and MedDRA coding

oligozoospermia

Study design 1 period

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 6

1. Male aged between 21 and 55 years (inclusive)
2. 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
3. Infertility lasting more than 12 months
4. Patient affiliated with or benefiting from a health insurance scheme
5. Patient able to understand the objectives and risks of the study and provide dated and signed informed consent
6. Patient informed of the results of the preliminary medical examination

Exclusion criteria 25

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

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. The primary evaluation criterion is sperm production measured after 20 weeks of weekly isotretinoin treatment, compared to that of men who received a placebo

Secondary endpoints 1

1. Sperm motility and morphology after 20 weeks of weekly isotretinoin treatment

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Placebo 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Les Hopitaux Universitaires De Strasbourg

Sponsor organisation

Les Hopitaux Universitaires De Strasbourg

Address

1 Place De L Hopital, Cs 80426 Cs 80426

City

Strasbourg Cedex

Postcode

67091

Country

France

Scientific contact point

Organisation

Les Hopitaux Universitaires De Strasbourg

Contact name

Marius TELETIN

Public contact point

Organisation

Les Hopitaux Universitaires De Strasbourg

Contact name

Marius TELETIN

Locations

1 EU/EEA country · 3 investigational sites

By country

Investigational sites

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 8 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

1 submissions — initial application plus substantial / non-substantial modifications