DRKS00030049招募中不适用
Disease Activity and Fertility in Women with highly active Multiple Sclerosis seeking Pregnancy
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 262
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18 Years 至 40 Years（—）
- 性别
- Female
入选标准
- •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
排除标准
- •- 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
研究者
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