Multiple SclerosisFERTIMUSNCT07164924
Evaluation of the Impact of Multiple Sclerosis and Its Treatments on Women Fertility
An observational study of Multiple Sclerosis and Neuromyelitis Optica Spectrum Disorders, run by University Hospital, Clermont-Ferrand at 27 sites in 2 countries.
Trial summary
CONTEXT A desire for pregnancy is common in young patients with multiple sclerosis (MS). The impact of MS on women fertility is debated, and the impact of disease-modifying therapies (DMTs) on fertility is not well known. Read more about this study
- Who is it for?
- Ages 18 to 35 years, women only
- Conditions the study is for
- Multiple Sclerosis, Neuromyelitis Optica Spectrum Disorders, Fertility
- What is being tested?
- blood sample to analyse AMH level on the serum
- How many people
- 800 participants
- Where
- 27 sitesin 2 countries
- Study dates
- 1 Jan 2018to 8 Dec 2024
- How long will I take part?
- 2 Years
- Phase
- Observational
- Are there results?
- None posted in the registry
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 18 to 35 years
- Women only
- No healthy volunteers
- Adult
Study population: Women, with age between 18 at 35, with a diagnosis of MS or NMOSD , present in EDMUS database, which has a blood sample in the OFSEP cohort
Who may be able to join
- Female
- Diagnosis of MS (including CIS) or NMOSD
- Aged 18 to 35 years old at blood sample collection
Who cannot join
- Diagnosis of radiologically isolated syndrome (RIS)
- Age less than18 or more than 35.
- History of ovarian surgery
- Endometriosis
- Hypergonadotropin amenohrrea
- Any associated known autoimmune disease other than MS
- Previous MS treatment with immunosuppressive agents such as azathioprine, cyclophosphamide, mitoxantrone, bone marrow transplantation
- Previous treatment with gonadotoxic drugs (eg chemotherapy)
Trial locations and contacts
27 sites in 2 countries.
27 sites in 2 countries
France26 sites
CHU Amiens
Amiens
CHU Besancon
Besançon
CHU Bordeaux
Bordeaux
CHU Caen
Caen
CHU Clermont-Ferrand
Clermont-Ferrand, 63000
AP-HP - Créteil
Créteil
CHU Dijon
Dijon
CHU Grenoble
Grenoble
CHU Lille
Lille
CHU Limoges
Limoges
Hospices Civils de Lyon
Lyon
AP-HM
Marseille
CHU Montpellier
Montpellier
CHU Nancy
Nancy
CHU Nantes
Nantes
CHU Nice
Nice
CHU Nîmes
Nîmes
Hôpital de la Pitié-Salpêtrière
Paris
Hôpital Fondation Rothschild
Paris
Hôpital Saint Antoine
Paris
CHI Poissy- Saint-Germain-en-Laye
Poissy
CHU Poitiers
Poitiers
CHU Rennes
Rennes
CHU Strasbourg
Strasbourg
CHU Toulouse
Toulouse
CHU Tours
Tours
About this study
CONTEXT A desire for pregnancy is common in young patients with multiple sclerosis (MS). The impact of MS on women fertility is debated, and the impact of disease-modifying therapies (DMTs) on fertility is not well known. Antimüllerian hormone (AMH) is a representative biomarker of ovarian reserve that can be used to explore this issue.
OBJECTIVES To examine the impact of MS activity and related DMTs on ovarian reserve measured by serum AMH level.
Read more
METHODOLOGY Retrospective multicentre study based on clinical and blood samples from patients included in the OFSEP cohort. A serum sample from more than 800 MS and 96 NMOSD women aged 18-35 will be available for AMH dosing. The results obtained will be interpreted taking into account the age, the inflammatory activity of the disease, the disability (EDSS) and the previous and current DMTs used.
STATISTICAL ANALYSIS Spearman correlation coefficient will be calculated in univariate analysis between serum AMH level and number of relapses that occurred during the 2 years before blood sample collection. For multivariable analysis, multiple mixed linear regression will be performed with AMH level as dependant outcome and number of relapses, age, DMTs (highly active, moderately active or no treatment), disease duration and disability (measured using EDSS) as independent variables. The center will be considered as random-effect. For AMH level categorized as normal or not, mixed logistic regression will be performed with aforementioned covariates. These analyses will be completed by a mediation analysis between AMH level, number of relapses and DMTs with age, EDSS and disease duration as adjustments covariates.
EXPECTED RESULTS :
Evaluation of the potential relationship between AMH levels and MS or NMOSD activity at the first years of the illness.
Evaluation of the potential impact of MS and NMOSD treatments on ovarian reserve.
Optimization of the indications of fertility preservation for MS and NMOSD female patients.
- Being tested
- blood sample to analyse AMH level on the serum
- Keywords
- Fertility, Anti-Mullerian Hormone (AMH), Multiple sclerosis (MS), Female, Disease activity
- Medical subject headings
- Multiple Sclerosis, Neuromyelitis Optica
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
blood sample to analyse AMH level on the serumBiological
Evaluation of MS/NMOSD inflammatory activity on the serum AMH level (ng/ml)
| Study group | Role | What they receive |
|---|---|---|
| MS / NMOSD female patients | MS / NMOSD female patients , aged between 18 and 35, with or without MS treatment Receives: Biological: blood sample to analyse AMH level on the serum |
What is being measured
The primary outcome is the main question the study is designed to answer.
the evaluation of MS/NMOSD inflammatory activity on the serum AMH level (ng/ml)
Disease activity will be evaluated on the number of relapses that occurred during the 2 years before blood sample collection and total number of relapses, taking disease duration into account.
The measurement of AMH level will be performed using the electrochemiluminescence method with a Cobas® e411 analyzer (Roche Diagnostics, Meylan, France). This immunoassay is based on a sandwich format between the analyte and the two antibodies: a biotinylated AMH-specific mouse monoclonal capture antibody and a second ruthenium-labeled AMH mouse monoclonal antibody. This assay is a fully automated, robust and precise method. Repeatability and intermediate precision calculated on serum samples range from 1.1% to 1.8% and 3.3% to 4.4%, respectively. The assay time is 18 minutes and the measuring range is from 0.01 to 23 ng/ml. The threshold of inf at1 ng/ml will be considered to be a proof of severe decrease in ovarian reserve
Measured: period of 2 years before blood samples
Secondary outcomes (1)
Evaluation of the potential impact of previous treatments used on AMH level
The treatments used will be pooled in highly active treatments (NATALIZUMAB, FINGOLIMOD, PONESIMOD, OFATUMUMAB, ALEMTUZUMAB, CLADRIBINE, OCRELIZUMAB, RITUXIMAB), moderately active (INTERFERON BETA, ACETATE DE GLATIRAMERE, DIMETHYLFUMARATE, LAQUINIMOD, MYCOPHENOLATE MOFETIL, METHOTREXATE) or no treatment.
Measured: period before the collection of AMH level
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2025
- Study start1 Jan 2018
- Primary completion8 Dec 2024
- Study completion8 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple SclerosisStudies of the same condition, open and under way.
- More trials run by University Hospital, Clermont-FerrandThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 800 participants (actual)
- Target duration
- 2 Years
Sponsor and investigators
- Lead sponsor
- University Hospital, Clermont-Ferrand
- Sponsor type
- University, hospital or other
- Collaborators
- Observatoire Français de la sclérose en plaques (OFSEP), Roche Diagnostic Ltd., ARSEP foundation
- Responsible party
- Sponsor
- Investigators
- Pierre Clavelou, Principal investigator, University Hospital, Clermont-Ferrand
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07164924
- Sponsor's protocol ID
- 2024-CF243
- Acronym
- FERTIMUS
- Status last verified
- Jul 2024
- First submitted
- 6 Mar 2025
- Last updated
- 10 Sep 2025
- 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 10 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Impact of Multiple Sclerosis and Its Treatments on Women Fertility
- ClinicalTrials.gov ID
- NCT07164924
- Acronym / sponsor ID
- FERTIMUS / 2024-CF243
- Keywords
- Fertility, Anti-Mullerian Hormone (AMH), Multiple sclerosis (MS), Female, Disease activity
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 800 participants (actual)
- Lead sponsor
- University Hospital, Clermont-FerrandUniversity, hospital or other
- Collaborators
- Observatoire Français de la sclérose en plaques (OFSEP), Roche Diagnostic Ltd., ARSEP foundation
- Study start
- 1 Jan 2018 (actual)
- Primary completion
- 8 Dec 2024 (actual)
- Study completion
- 8 Dec 2024 (actual)
- First posted
- 10 Sep 2025 (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.
CONTEXT A desire for pregnancy is common in young patients with multiple sclerosis (MS). The impact of MS on women fertility is debated, and the impact of disease-modifying therapies (DMTs) on fertility is not well known. Antimüllerian hormone (AMH) is a representative biomarker of ovarian reserve that can be used to explore this issue.
OBJECTIVES To examine the impact of MS activity and related DMTs on ovarian reserve measured by serum AMH level.
METHODOLOGY Retrospective multicentre study based on clinical and blood samples from patients included in the OFSEP cohort. A serum sample from more than 800 MS and 96 NMOSD women aged 18-35 will be available for AMH dosing. The results obtained will be interpreted taking into account the age, the inflammatory activity of the disease, the disability (EDSS) and the previous and current DMTs used.
STATISTICAL ANALYSIS Spearman correlation coefficient will be calculated in univariate analysis between serum AMH level and number of relapses that occurred during the 2 years before blood sample collection. For multivariable analysis, multiple mixed linear regression will be performed with AMH level as dependant outcome and number of relapses, age, DMTs (highly active, moderately active or no treatment), disease duration and disability (measured using EDSS) as independent variables. The center will be considered as random-effect. For AMH level categorized as normal or not, mixed logistic regression will be performed with aforementioned covariates. These analyses will be completed by a mediation analysis between AMH level, number of relapses and DMTs with age, EDSS and disease duration as adjustments covariates.
EXPECTED RESULTS :
Evaluation of the potential relationship between AMH levels and MS or NMOSD activity at the first years of the illness.
Evaluation of the potential impact of MS and NMOSD treatments on ovarian reserve.
Optimization of the indications of fertility preservation for MS and NMOSD female patients.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Target follow-up
- 2 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| MS / NMOSD female patients | – | Biological: blood sample to analyse AMH level on the serumMS / NMOSD female patients , aged between 18 and 35, with or without MS treatment |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Women, with age between 18 at 35, with a diagnosis of MS or NMOSD , present in EDMUS database, which has a blood sample in the OFSEP cohort
Key inclusion criteria (3 listed)
- Female
- Diagnosis of MS (including CIS) or NMOSD
- Aged 18 to 35 years old at blood sample collection
Key exclusion criteria (8 listed)
- Diagnosis of radiologically isolated syndrome (RIS)
- Age less than18 or more than 35.
- History of ovarian surgery
- Endometriosis
- Hypergonadotropin amenohrrea
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 |
|---|---|---|
| blood sample to analyse AMH level on the serumEvaluation of MS/NMOSD inflammatory activity on the serum AMH level (ng/ml) | Biological | MS / NMOSD female patients |
Primary outcome
the evaluation of MS/NMOSD inflammatory activity on the serum AMH level (ng/ml)
Time frame: period of 2 years before blood samples
Disease activity will be evaluated on the number of relapses that occurred during the 2 years before blood sample collection and total number of relapses, taking disease duration into account. The measurement of AMH level will be performed using the electrochemiluminescence method with a Cobas® e411 analyzer (Roche Diagnostics, Meylan, France). This immunoassay is based on a sandwich format between the analyte and the two antibodies: a biotinylated AMH-specific mouse monoclonal capture antibody and a second ruthenium-labeled AMH mouse monoclonal antibody. This assay is a fully automated, robust and precise method. Repeatability and intermediate precision calculated on serum samples range from 1.1% to 1.8% and 3.3% to 4.4%, respectively. The assay time is 18 minutes and the measuring range is from 0.01 to 23 ng/ml. The threshold of inf at1 ng/ml will be considered to be a proof of severe decrease in ovarian reserve
1 secondary outcome
Evaluation of the potential impact of previous treatments used on AMH level
Time frame: period before the collection of AMH level
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Sep 2025.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Pierre Clavelou principal investigator
University Hospital, Clermont-Ferrand
27 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Multiple Sclerosis and Neuromyelitis Optica Spectrum Disorders, run by University Hospital, Clermont-Ferrand at 27 sites in 2 countries.
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 3 inclusion and 8 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: finished, as of the sponsor's last update on 10 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 27 sites in France, Martinique. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the evaluation of MS/NMOSD inflammatory activity on the serum AMH level (ng/ml) (time frame: period of 2 years before blood samples). 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 10 Sep 2025.