The Microbiome of Infertile Couples and Its Effect on Their Reproductive Outcomes
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 1,850
- 试验地点
- 1
- 主要终点
- Abnormal vaginal microbiota
研究概览
简要总结
A prospective cohort study in IVF patients at 5 IVF centres in Denmark. The primary aim is to include patients positive for abnormal vaginal microbiota to an RCT (EUDRACT 2016-002385-31). Secondary aims are the prevalence of abnormal vaginal microbiota in women undergoing IVF treatment, intimate hygiene and relations to the vaginal microbiota, basic fertility work up in relation to vaginal microbiota.
详细描述
At the time of the interim stage of the RCT (EUDRACT 2016-002385-31), we plan to make a first cross-sectional investigation of the intimate hygiene questionnaire at baseline as compared to abnormal vaginal microbiota. We plan to make focused interview of N=30 patients to cover any additional female hygiene details not covered in the original questionnaire. After this investigation we may include new questions after the interim analysis - given that the study proceeds. In this case we plan to publish the first results of the intimate hygiene habits of the patients enrolled until interim stage.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Other
入排标准
- 年龄范围
- 18 Years 至 42 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •First, second or third IVF stimulation cycle at the involved clinic.
- •Written informed consent.
- •18-42 years old
排除标准
- •HIV, Hepatitis B or C positivity.
- •Intrauterine malformations (Vaginal ultrasound)
- •Hysterosalpinx
- •Known severe renal or hepatic impairment.
- •HPV CIN 2 or higher.
- •Patients treated with vitamin K antagonists (warfarin)
- •Known or suspected hypersensitivity to clindamycin or any other antibiotic.
- •Myastenia Gravis
- •Former or current inflammatory bowel disease, including Mb. Crohn and Colitis ulcerosa
- •Any uncontrolled concomitant disease (e.g. uncontrolled diabetes, uncontrolled hypertension etc.)
结局指标
主要结局
Abnormal vaginal microbiota
时间窗: minimum 2-7 days from vaginal swab.
qPCR positive diagnosis as described in intervention.
次要结局
- Number of participants achieving Live birth (defined as birth of a living child later than 23 weeks)(36-42 weeks after inclusion)
- Intimate hygiene(2-5 weeks from baseline to embryo transfer)
- Male/partner seminal microbiome(2-4 weeks from baseline to oocyte pick-up)
- Number of participants with Clinical pregnancy as measured by heartbeat(7-9 weeks after inclusion.)
- Cumulative live birth rate(9 months - 24 months after inclusion)
研究者
Peter Humaidan
Professor, Consultant
Regionshospitalet Viborg, Skive