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O estudo clínico NCT05754593 (FEMINISEP) para Esclerose múltipla está recrutando. Consulte a visualização em cartões do Radar de Estudos Clínicos e as ferramentas de descoberta de IA para ver todos os detalhes. Ou pergunte qualquer coisa aqui. | ||
Study of Ovarian Reserve Concerning Patients With Multiple Sclerosis (MS), Compared to a Control Group (FEMINISEP)
Few studies suggest that there is an negative impact of multiple sclerosis on ovarian reserve, with a combined mechanism ( inflammatory and autoimmune mechanism). The investigators can hypothesize that patients with multiple sclerosis are more predisposed to have primary ovarian insufficiency.
Ovarian reserve is evaluated by Anti-Mullerian Hormone (AMH) dosage and antral follicle count (AFC) by ultrasound imaging.AMH levels can be measured at every moment of the menstrual cycle whereas AFC is preferentially performed between the second and the eighth day of the menstrual cycle. The combined use of this two markers is well known to be correlated with ovarian reserve. Only a few studies have evaluated ovarian reserve in patients with multiple sclerosis. Besides, there is only a few number of participants and results are contradictory. A decrease of ovarian reserve identified among patients with multiple sclerosis could lead to an orientation in a fertility preservation center.
This project is a monocentric study realized at Pellegrin Hospital - Bordeaux. Patients with multiple sclerosis belong to a cohort of the neurology center. Healthy women come from a volunteer base contacted by email.The two groups are matched thanks to answers of a short questionnaire.Measure of AMH level is performed at pellegrin Hospital at the medical laboratory. Ultrasound imaging is performed by the center of women imagery at Pellegrin Hospital. Results are communicated by teleconsultation two months later. If there is an anormal result, a specific appointment will be organized with a gynecologist.
Study of Ovarian Reserve Concerning Patients With Multiple Sclerosis, Compared to a Control Group
- FEMINISEP
- CHUBX 2022/27
ovarian reserve
fertility
auto-immunity
| Grupo de participantes/Braço | Intervenção/Tratamento |
|---|---|
ExperimentalMS patients Diagnosis of multiple sclerosis based on McDonald Criteria 2017 | Anti-mullerian Hormone (AMH) Level Measure of Anti-Mullerian hormone (AMH) level by blood sample Antral Follicle Count (AFC) Measure of Antral follicle count (AFC) by ultrasound imaging Avaliação clínica MS history and MS treatments and Expanded Disability Status Scale (EDSS) score will be recorded |
Comparador ativoControls Healthy controls | Anti-mullerian Hormone (AMH) Level Measure of Anti-Mullerian hormone (AMH) level by blood sample Antral Follicle Count (AFC) Measure of Antral follicle count (AFC) by ultrasound imaging |
| Medida de desfecho | Descrição da medida | Prazo |
|---|---|---|
Measure of Anti-Mullerian hormone (AMH) level by blood sample to compare ovarian reserve between patients with multiple sclerosis versus healthy controls from 25 to 35 years old. | At baseline (day 0) |
| Medida de desfecho | Descrição da medida | Prazo |
|---|---|---|
Measure of Antral follicle count (AFC) by ultrasound imaging to compare ovarian reserve between patients with multiple sclerosis versus healthy controls from 25 to 35 years old. | At baseline (day 0) |
- 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.
- 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).
University Hospital, Bordeaux