Volunteers without MS G35
Conditions
Interventions
Group 1: Standardized monthly telephone interviews during active family planning for a maximum of 12 months.
Group 2: Controll Group (Volunteers without MS): Standardized monthly telephone interviews
Sponsors
St. Josef-Hospital
Eligibility
Sex/Gender
Female
Age
18 Years to 40 Years
Inclusion criteria
Inclusion criteria: - Ability to understand the purpose of the study - Provide informed consent - Women aged 18 to 40 years with the desire to have children - Women with a RRMS diagnosis and a highly active disease course, defined as i) treatment with highly-effective DMTs before planning a pregnancy, or ii) at least one relapse under basic treatment (interferon-ß formulations, glatiramer acetate formulation, dimethyl fumarate) during the last year prior to withdrawal of contraception or iii) at least two relapses without treatment during the last year prior to withdrawal of contraception - women without MS (control group) - steady male partner - discontinuation of any method of contraception within the previous 6 months or planning to do so within 6 months of providing informed consent
Exclusion criteria
Exclusion criteria: - Unable or unwilling to provide informed consent - PPMS or SPMS Diagnosis - current attempt to achieve pregnancy for more than 6 months - demonstrated infertility with the same partner anytime in the past - breastfeeding - diagnoses of infertility - polycystic ovary syndrome (PCOS) - severe endometriosis - menopause - untreated thyroid disease - nipple discharge - hyperprolactinemia or other pituitary disease - smoking more than 10 cigarettes per day - planning to use medication to conceive or a sperm donor - The patient withdraws consent
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| - number of relapses and annualized relapse rates between withdrawal of contraception and pregnancy (or end of participation period if pregnancy is not achieved) - for all women withdrawing DMTs or switching from highly-effective DMTs to basic DMTs due to family planning, the number of relapses and annualized relapse rates between withdrawal of DMT and pregnancy (or end of participation period if pregnancy is not achieved) | — |
Secondary
| Measure | Time frame |
|---|---|
| - number of women achieving pregnancy in the cohort of women with highly active disease course and in the age matched control group of women without MS | — |
Countries
Germany
Contacts
Public ContactKerstin Hellwig
Department of Neurology, St. Josef Hospital
Outcome results
None listed