Evaluating ovarian reserve in women with multiple sclerosis
Study of Ovarian Reserve Concerning Patients With Multiple Sclerosis, Compared to a Control Group
This study is testing if women with multiple sclerosis have different ovarian reserve compared to healthy women to see if it affects their fertility.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 160 (estimated) |
| Ages | 25 Years to 35 Years |
| Sex | Female |
| Sponsor | University Hospital, Bordeaux Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Bordeaux) |
| Trial ID | NCT05754593 on ClinicalTrials.gov |
What this trial studies
This study aims to assess the ovarian reserve of women diagnosed with multiple sclerosis compared to a control group of healthy women aged 25 to 35. The evaluation will be conducted using Anti-Mullerian Hormone (AMH) levels and Antral Follicle Count (AFC) through ultrasound imaging. The study seeks to determine if multiple sclerosis negatively impacts ovarian reserve, potentially leading to fertility preservation considerations for affected patients. It is a monocentric study conducted at Pellegrin Hospital in Bordeaux.
Who should consider this trial
Good fit: Ideal candidates are reproductive women aged 25 to 35 with a diagnosis of multiple sclerosis.
Not a fit: Patients with a history of ovarian surgery, endometriosis, or those who are pregnant or breastfeeding may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide insights into fertility preservation options for women with multiple sclerosis.
How similar studies have performed: Few studies have explored ovarian reserve in multiple sclerosis, and results have been contradictory, indicating this approach is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Reproductive women between 25 and 35 years old ; * MS Patient : Diagnosis of multiple sclerosis based on McDonald Criteria 2017; * French-speaking, without comprehension disorders ; * being affiliated to health insurance ; * Willing to participate and to sign informed consent. Exclusion Criteria: * History of ovarian surgery (cystectomy, annexectomy) ; * Turner Syndrome ; * fragile X messenger ribonucleoprotein 1 (FMR1) premutation ; * Endometriosis with a risk of ovarian reserve alteration ; * History of chemotherapy or pelvic radiotherapy ; * Pregnant or breastfeeding women ; * patient concerned by articles L 1121-5 to L 1121-8 (persons deprived of their liberty by a judicial or administrative decision, minors, persons of legal age who are the object of a legal protection measure or unable to express their consent).
Where this trial is running
Bordeaux
- CHU de Bordeaux - service de neurologie — Bordeaux, France (Recruiting)
Study contacts
- Principal investigator: Valérie BERNARD, MD — University Hospital, Bordeaux
- Study coordinator: Valérie BERNARD, MD
- Email: valerie.bernard@chu-bordeaux.fr
- Phone: (0)5 56 79 56 79
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.