13-cis Retinoic Acid (Isotretinoin) and Sperm Production

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

PHASE4

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-03-01

Study Completion Date

2027-12-01

Brief Summary

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This study aims to evaluate the effectiveness of weekly administration of isotretinoin (40 mg) in increasing sperm production in men with oligozoospermia, a condition characterized by a low sperm count. Participants will be randomized into two groups: one receiving isotretinoin and the other a placebo. The primary outcome will be the change in sperm production over 20 weeks of treatment.

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Detailed Description

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Conditions

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Men with Infertility

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Isotretinoin

Isotretinoin (40 mg) orally, once per week for 20 weeks

Group Type EXPERIMENTAL

Isotretinoin

Intervention Type DRUG

ARESPERM is a multicenter, randomized, double-blind, placebo-controlled study that assesses whether a weekly dose of isotretinoin can stimulate spermatogenesis in men with oligozoospermia. The study hypothesizes that isotretinoin can trigger the differentiation of spermatogonial cells, leading to improved sperm production.

control group

Placebo identical in appearance and administration schedule.

Group Type PLACEBO_COMPARATOR

Control group (placebo)

Intervention Type DRUG

placebo administration

Interventions

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Isotretinoin

ARESPERM is a multicenter, randomized, double-blind, placebo-controlled study that assesses whether a weekly dose of isotretinoin can stimulate spermatogenesis in men with oligozoospermia. The study hypothesizes that isotretinoin can trigger the differentiation of spermatogonial cells, leading to improved sperm production.

Intervention Type DRUG

Control group (placebo)

placebo administration

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Subjects will be infertile men (no pregnancy with partner with normal cycles and normal hysterosalpingogram despite \>1 year of unprotected intercourse).
* Abnormal sperm analyses with a total, motile sperm count of less than 10 million sperm as assessed by semen analysis on two occasions separated by one week.
* Male patients aged 21-55 years
* Affiliation with a social security system
* Ability to provide informed consent

Exclusion Criteria

* -Men participating in another clinical trial
* Clinically significant abnormal findings at screening
* Known genetic infertility (e.g. Klinefelter syndrome or Y-chromosome microdeletions),
* Hypogonadotropic hypogonadism (that might respond to gonadotropin injections),
* Severe mental health problems requiring medications
* Current therapy with retinoic acid (e.g. Accutane) or vitamin A.
* History of psychiatric disorders (e.g., depression, suicidal tendencies).
* Abnormal serum chemistry values according to local laboratory normal values which indicate liver or kidney dysfunction.
* Men currently receiving tetracycline containing medications
* Men who have used isotretinoin within eight weeks of the start of dosing
* Men with elevated serum triglycerides

Minimum Eligible Age

21 Years

Maximum Eligible Age

55 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No