Study evaluating the effect of isotretinoin on sperm production in men with low sperm count

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What is this study about?

This study focuses on oligozoospermia, a condition where there is a low count of sperm in the semen. The purpose of the research is to evaluate the effectiveness of isotretinoin on sperm production. Participants in the study will receive either the medication or a placebo.

During the study, individuals will take a weekly dose of isotretinoin, which is a form of retinoic acid, an active substance used in various treatments. The course of the study involves taking this medication for a period of 20 weeks to observe how it affects the production of sperm, as well as the sperm motility, which refers to how well the sperm can move, and sperm morphology, which relates to the shape and structure of the sperm cells.

Who Can Join the Study?

You must be a male between the ages of 21 and 55 years old.
You must have a diagnosis of oligozoospermia, which means having a low sperm count (specifically, fewer than 15 million sperm per milliliter of fluid, or fewer than 39 million sperm in total during an ejaculation).
This low sperm count must have been confirmed by two separate semen analyses (tests that check the quality and amount of sperm) performed at least one month apart within the last 12 months.
You must have experienced infertility, which is the inability to conceive a child, lasting for more than 12 months.
You must be covered by a health insurance scheme.
You must be able to understand the goals and potential risks of the study and provide a signed informed consent, which is a formal document where you agree to participate after being fully told what the study involves.
You must be informed of the results of your preliminary medical examination, which is the initial health checkup performed before joining the study.

Who Cannot Join the Study?

Having a known genetic cause of infertility, which means an inherited problem with your DNA or chromosomal abnormalities (errors in the structure or number of chromosomes) that prevents making babies.
Taking any vitamin A supplements currently.
Having hepatic insufficiency, which is a condition where the liver is not working correctly, identified by high levels of specific liver enzymes called ASAT and ALAT in your blood.
Having severe renal insufficiency, which means your kidneys are not working properly, identified by albuminuria (protein in the urine) or abnormal creatinine levels (a waste product in the blood).
A history of severe allergic or anaphylactic reactions, which are dangerous and life-threatening allergic responses.
Having a known psychiatric disorder, such as depression, psychotic symptoms, or mood changes, measured by a specific mental health test score.
A known history of suicide attempts or a known risk of suicide.
Having had surgery of the genitourinary tract (the organs involved in urination and reproduction) within the last year.
Using isotretinoin (a type of medication often used for skin) within the 3 months before joining the study.
Using tobacco by smoking more than 5 cigarettes per day.
Chronic alcohol consumption, which means regular and long-term drinking of alcohol.
Having hypogonadotropic hypogonadism, a condition where the body does not produce enough hormones to regulate the reproductive system.
Using any systemic medication (medicine that travels through the whole body) within the 3 months before joining.
Being unable to agree to not donate blood during the treatment and for one month after.
Currently participating in another medical study.
Being under legal guardianship, curatorship, or judicial protection, which means a court has appointed someone to make decisions for you.
The inability to provide informed consent, meaning you cannot understand or sign the document that explains the study.
Having any other medical condition that interferes with spermatogenesis, which is the process of the body creating sperm.
A known hypersensitivity (extreme allergy) to isotretinoin or any of its excipients (the inactive ingredients used to make the medicine).
Having hyperlipidemia, which means having high levels of fats like triglycerides in your blood.
Having hypervitaminosis A, which is a condition caused by having too much vitamin A in your body.
A known allergy to peanut oil, soybean oil, or magnesium stearate.
Using other retinoids (medicines related to vitamin A) currently.
Using any medication that interferes with the body’s ability to create sperm or process vitamin A, such as certain antibiotics or anti-seizure medications.

Where you can join this trial?

Verified and Recommended Sites

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Verified Sites

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Other Sites

Site Name	City	Country
Groupe Hospitalier De La Region De Mulhouse Et Sud Alsace	Mulhouse	France
Centre Hospitalier Universitaire De Rennes	Rennes	France
Hbsyufmt Ueqckkntrnwolb Ssucyfeqqs &boionw Hhholua db Hirvxrzxlpp	STRASBOURG, Alsace	France

Trial status

Country	Status	Recruitment Start
France	Not yet recruiting	01.01.2026

Trial locations

Investigated drugs:

Isotretinoin

Isotretinoin is a medication taken by mouth that is being studied to see how it affects the production of sperm in men who have low sperm counts.

Investigated diseases:

Infertility male

Oligozoospermia – This condition is characterized by a lower than normal concentration of sperm in a man’s semen. It occurs when the production of sperm cells in the testes is reduced. The condition may be present from birth or develop later in life due to various biological factors. As it progresses, the total number of sperm available for reproduction remains below the standard threshold. This reduction can affect the overall quality and quantity of the sperm cells produced.

Trial ID:

2024-519644-33-00

Protocol code:

7345

Trial Phase:

Therapeutic exploratory (Phase II)

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Study evaluating the effect of isotretinoin on sperm production in men with low sperm count

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?