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NCT07164924: FERTIMUS
Evaluation of the Impact of Multiple Sclerosis and Its Treatments on Women Fertility
trial testing blood sample to analyse AMH level on the serum in Multiple Sclerosis in 800 participants. Completed in 8 December 2024.
8 December 2024
Quick facts
| Lead sponsor | University Hospital, Clermont-Ferrand |
|---|---|
| Status | Completed |
| Study type | OBSERVATIONAL |
| Enrollment | 800 |
| Start date | 1 January 2018 |
| Primary completion | 8 December 2024 |
| Estimated completion | 8 December 2024 |
| Sites | 27 locations across Martinique, France |
Drugs / interventions tested
- blood sample to analyse AMH level on the serum — full drug profile →
Conditions studied
- Multiple Sclerosis — all drugs for Multiple Sclerosis →
- Neuromyelitis Optica Spectrum Disorders — all drugs for Neuromyelitis Optica Spectrum Disorders →
- Fertility — all drugs for Fertility →
Sponsor
University Hospital, Clermont-Ferrand
Who can join
Adults 18 to 35, female only, with Multiple Sclerosis or Neuromyelitis Optica Spectrum Disorders. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT07164924
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT07164924 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by University Hospital, Clermont-Ferrand
- Last refreshed: 10 September 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT07164924.
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