NCT06698263

Brief Summary

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.

Trial Health

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Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for phase_4

Timeline
20mo left

Started Mar 2025

Typical duration for phase_4

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress43%
Mar 2025Dec 2027

First Submitted

Initial submission to the registry

November 18, 2024

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 20, 2024

Completed
3 months until next milestone

Study Start

First participant enrolled

March 1, 2025

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2027

Last Updated

November 25, 2024

Status Verified

November 1, 2024

Enrollment Period

2.8 years

First QC Date

November 18, 2024

Last Update Submit

November 21, 2024

Conditions

Men with Infertility

Outcome Measures

Primary Outcomes (5)

  • Millions of Sperm Per Ejaculate

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

    Day 0

  • Millions of Sperm Per Ejaculate

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

    Months 2

  • Millions of Sperm Per Ejaculate

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

    Months 5

  • Millions of Sperm Per Ejaculate

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

    Months 12

  • Millions of Sperm Per Ejaculate

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

    Months 24

Study Arms (2)

Isotretinoin

EXPERIMENTAL

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

Drug: Isotretinoin

control group

PLACEBO COMPARATOR

Placebo identical in appearance and administration schedule.

Drug: Control group (placebo)

Interventions

IsotretinoinDRUG

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.

Isotretinoin
Control group (placebo)DRUG

placebo administration

control group

Eligibility Criteria

Age21 Years - 55 Years
Sexmale(Gender-based eligibility)
Gender Eligibility Detailsjust man
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CECOS Alsace Strasbourg

Schiltigheim, 67300, France

Location

MeSH Terms

Interventions

IsotretinoinControl Groups

Intervention Hierarchy (Ancestors)

RetinoidsCarotenoidsPolyenesAlkenesHydrocarbons, AcyclicHydrocarbonsOrganic ChemicalsCyclohexenesCyclohexanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicTerpenesPigments, BiologicalBiological FactorsEpidemiologic Research DesignEpidemiologic MethodsInvestigative TechniquesResearch DesignMethods

Central Study Contacts

Sarah Hustache

CONTACT

0388116768dpidrci@chru-strasbourg.fr

Marius Teletin, MD

CONTACT

marius.teletin@chru-strasbourg.fr

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 18, 2024

First Posted

November 20, 2024

Study Start

March 1, 2025

Primary Completion (Estimated)

December 1, 2027

Study Completion (Estimated)

December 1, 2027

Last Updated

November 25, 2024

Record last verified: 2024-11

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)