Disease Activity and Fertility in Women with highly active Multiple Sclerosis seeking Pregnancy

Recruiting

Conditions: Volunteers without MS
G35
Multiple sclerosis

Registration Number: DRKS00030049

Lead Sponsor: St. Josef-Hospital

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: Female

Target Recruitment: 262

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

- 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

Study & Design

Study Type: observational

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
- number of relapses and annualized relapse rates between withdrawal of contraception and pregnancy (or end of participation period if pregnancy is not achieved) <br>- 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 Outcome Measures

Name	Time	Method
- 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