13-cis Retinoic Acid (Isotretinoin) and Sperm Production (ARESPERM)

University Hospital, Strasbourg, France

Status and phase: Not yet enrolling; Phase 4

Conditions: Men with Infertility

Treatments: Drug: Isotretinoin; Drug: Control group (placebo)

Study type: Interventional

Funder types: Other

Identifiers

NCT06698263

2024-519644-33-00 (EU Trial (CTIS) Number)

7345

Details and patient eligibility

About

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.

Enrollment: 100 estimated patients

Sex: Male

Ages: 21 to 55 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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100 participants in 2 patient groups, including a placebo group

Isotretinoin

Experimental group

Description:

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

Treatment:

Drug: Isotretinoin

control group

Placebo Comparator group

Description:

Placebo identical in appearance and administration schedule.

Treatment:

Drug: Control group (placebo)