Men with InfertilityPhase 4ARESPERMNCT06698263
13-cis Retinoic Acid (Isotretinoin) and Sperm Production
A Phase 4 study testing Isotretinoin in people with Men with Infertility, run by University Hospital, Strasbourg, France at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 to 55 years, men only
- Conditions the study is for
- Men with Infertility
- What is being tested?
- Isotretinoin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteFrance
- Study dates
- 1 Mar 2025to 1 Dec 2027
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 55 years
- Men only
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- -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.
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- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Marius Teletin, MD contact
France1 site
CECOS Alsace Strasbourg
Schiltigheim, 67300
Marius Teletin, MD, 03 69 55 35 30, marius.teletin@chru-strasbourg.fr
Marius Teletin, MD
About this study
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.
- Conditions
- Men with Infertility
- Being tested
- Isotretinoin, Control group (placebo)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
Control group (placebo)Drug
placebo administration
| Study group | Role | What they receive |
|---|---|---|
| Isotretinoin | Experimental | Isotretinoin (40 mg) orally, once per week for 20 weeks Receives: Drug: Isotretinoin |
| control group | Placebo comparator | Placebo identical in appearance and administration schedule. Receives: Drug: Control group (placebo) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Millions of Sperm Per Ejaculate
Concentration calculation of Millions of sperm per ejaculate in men treated with 13-cis retinoic acid
Measured: Day 0
Millions of Sperm Per Ejaculate
Concentration calculation of Millions of sperm per ejaculate in men treated with 13-cis retinoic acid
Measured: Months 2
Millions of Sperm Per Ejaculate
Concentration calculation of Millions of sperm per ejaculate in men treated with 13-cis retinoic acid
Measured: Months 5
Millions of Sperm Per Ejaculate
Concentration calculation of Millions of sperm per ejaculate in men treated with 13-cis retinoic acid
Measured: Months 12
Millions of Sperm Per Ejaculate
Concentration calculation of Millions of sperm per ejaculate in men treated with 13-cis retinoic acid
Measured: Months 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2024
- Study start1 Mar 2025 (estimated)
- Primary completion1 Dec 2027 (estimated)
- Study completion1 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Men with InfertilityStudies of the same condition, open and under way.
- More trials run by University Hospital, Strasbourg, FranceThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Strasbourg, France
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06698263
- Sponsor's protocol ID
- 7345
- Other IDs
- 2024-519644-33-00
- Acronym
- ARESPERM
- Status last verified
- Nov 2024
- First submitted
- 18 Nov 2024
- Last updated
- 25 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 13-cis Retinoic Acid (Isotretinoin) and Sperm Production
- ClinicalTrials.gov ID
- NCT06698263
- Acronym / sponsor ID
- ARESPERM / 7345
- Conditions
- Men with Infertility
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University Hospital, Strasbourg, FranceUniversity, hospital or other
- Study start
- 1 Mar 2025 (estimated)
- Primary completion
- 1 Dec 2027 (estimated)
- Study completion
- 1 Dec 2027 (estimated)
- First posted
- 20 Nov 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Isotretinoin | Experimental | Drug: IsotretinoinIsotretinoin (40 mg) orally, once per week for 20 weeks |
| control group | Placebo comparator | Drug: Control group (placebo)Placebo identical in appearance and administration schedule. |
Who may qualify
- Ages
- 21 to 55 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (11 listed)
- -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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| IsotretinoinARESPERM 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. | Drug | Isotretinoin |
| Control group (placebo)placebo administration | Drug | control group |
Primary outcome
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
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
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
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
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Nov 2024.
- Individual participant dataSharing planned: No
Related trials for Men with Infertility
Active, not recruitingObservational study
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Effects of Visceral Osteopathic Massage on Semen Parameters and Hemodynamics Factors in Varicocele
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Selective Extended Venous Stripping Versus Standard Microsurgical Varicocelectomy for Varicocele-Related Male Infertility
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Marius Teletin, MD contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Isotretinoin in people with Men with Infertility, run by University Hospital, Strasbourg, France at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 25 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sarah Hustache (0388116768, dpidrci@chru-strasbourg.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Millions of Sperm Per Ejaculate (time frame: Day 0). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Nov 2024.