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NCT Number: NCT06698263

13-cis Retinoic Acid (Isotretinoin) and Sperm Production

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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Key information

Conditions

Men with Infertility

Age range

21 year–55 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 4

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

isotretinoin

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)

Drug

placebo administration

Primary outcomes

  1. Millions of Sperm Per Ejaculate

    Time frame: Day 0

    Concentration calculation of Millions of sperm per ejaculate in men treated with 13-cis retinoic acid

  2. Millions of Sperm Per Ejaculate

    Time frame: Months 2

    Concentration calculation of Millions of sperm per ejaculate in men treated with 13-cis retinoic acid

  3. Millions of Sperm Per Ejaculate

    Time frame: Months 5

    Concentration calculation of Millions of sperm per ejaculate in men treated with 13-cis retinoic acid

  4. Millions of Sperm Per Ejaculate

    Time frame: Months 12

    Concentration calculation of Millions of sperm per ejaculate in men treated with 13-cis retinoic acid

  5. Millions of Sperm Per Ejaculate

    Time frame: Months 24

    Concentration calculation of Millions of sperm per ejaculate in men treated with 13-cis retinoic acid

Study contacts

Contact information is provided by the study sponsor or research team.

Marius Teletin, MD

CONTACT

[email protected]

Sarah Hustache

CONTACT

[email protected]

0388116768

Sponsors and collaborators

Lead sponsor

University Hospital, Strasbourg, France

Other

Registry information

Acronym: ARESPERM

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Nov 20, 2024
Registry last updated
Nov 25, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.