EUCTR2016-002385-31-DK进行中（未招募）1 期
A double-blind, placebo-controlled multicenter trial on the effect of clindamycin and a live biotherapeutic on the reproductive outcomes of IVF patients with abnormal vaginal microbiota
Professor Peter Humaidan, The Fertility Clinic Skive0 个研究点目标入组 333 人开始时间: 2016年7月11日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 333
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- Female
入选标准
- •Abnormal vaginal microbiota as described above.
- •First, second or third IVF treatment cycle.
- •Written informed consent.
- •18-42 years old
- •Max 2 embryos can be transferred
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 333
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •HIV, Hepatitis B or C positivity.
- •Known severe renal or hepatic impairment.
- •HPV CIN 2 or higher.
- •Lactose intolerans (medically diagnosed)
- •Patients treated with vitamin K antagonists (warfarin)
- •Known or suspected hypersensitivity to clindamycin
- •Myastenia Gravis
- •Intrauterine malformations
- •Former or current inflammatory bowel disease, including Mb. Crohn and Colitis ulcerosa
- •Severe concomitant disease (e.g. diabetes)
研究者
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