Evaluation of the Impact of Multiple Sclerosis and Its Treatments on Women Fertility

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Multiple Sclerosis Autoimmune Diseases Autoimmune Diseases of the Nervous System Cranial Nerve Diseases Demyelinating Autoimmune Diseases, CNS Demyelinating Diseases Eye Diseases Fertility Immune System Diseases Myelitis, Transverse Nervous System Diseases Neuromyelitis Optica Neuromyelitis Optica Spectrum Disorders Optic Nerve Diseases Optic Neuritis

Age range

18 year–35 year

Sex eligibility

Female

Study type

Observational

Primary location

CHU Amiens, Amiens, France

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

Female
Diagnosis of MS (including CIS) or NMOSD
Aged 18 to 35 years old at blood sample collection

Exclusion criteria

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)

Treatment and study plan

blood sample to analyse AMH level on the serum

Biological

Evaluation of MS/NMOSD inflammatory activity on the serum AMH level (ng/ml)

Primary outcomes

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

Secondary outcomes

Evaluation of the potential impact of previous treatments used on AMH level

Time frame: period before the collection of 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.

Sponsors and collaborators

Lead sponsor

University Hospital, Clermont-Ferrand

Other

Collaborators

ARSEP foundation
Observatoire Français de la sclérose en plaques (OFSEP)
Roche Diagnostic Ltd.

Registry information

Acronym: FERTIMUS

Important dates

Study start: 2018
Primary completion: 2024
Study completion: 2024
First posted: Sep 10, 2025
Registry last updated: Sep 10, 2025

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.

Published trials that share one or more normalized conditions with this study.

Not Yet Recruiting