The Temporo-spatial Dynamics of Genital Tract Microbiota - an Observational Study in IVF-Freeze All Patients Treated With Estradiol
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 27
- 试验地点
- 2
- 主要终点
- Rate of ascending infection/sharing of bacteria in the genital tract
研究概览
简要总结
The investigators aim to examine the endometrium with state of the art sequencing techniques to investigate the endometrial microbiota. The endometrial microbiota has been perceived to be sterile, however, this seems incorrect from recent studies. Thus, the primary outcome is to compare the rate of ascending infection from the semen to the vagina to the endometrium and to investigate which bacteria are capable of inhabiting these environments. Furthermore, cervical mucus will be obtained in order to test for immunological, microbiological and mechanical properties that may be involved in ascending infection. Finally, the study aim to characterize the temporal changes in the vaginal microbiota during estrogenic treatment with Estrofem® or Vivelle Dot (R) for preparation of the endometrium prior to embryo transfer.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients in IVF Freeze-all/segmentation treatment protocol.
- •Written informed consent.
排除标准
- •Uterine malformations
- •HIV, Hepatitis B or C positivity. HPV CIN 2 or higher. Chlamydia trachomatis positivity.
- •Any uncontrolled concomitant disease (e.g. uncontrolled diabetes, uncontrolled hypertension etc.)
研究组 & 干预措施
Abnormal microbiota
Based on qPCR and Next gen sequencing
干预措施: Estrofem (Drug)
结局指标
主要结局
Rate of ascending infection/sharing of bacteria in the genital tract
时间窗: This outcome data is measured at the day of oocyte retrieval.
Seminal, vaginal, cervical and endometrial samples will be compared at the time of oocyte retrieval.
次要结局
- Number of participants with a Clinical pregnancy(7-9 weeks after inclusion.)
- Next generation sequencing techniques will be used to assess the vaginal microbiota.I.e. measure of relative abundances(Examined longitudinally throughout the segmentation cycle. The estimated time to event is 40 days from oocyte retrieval until frozen embryo transfer following a strict protocol.)
- qPCR to assess the vaginal microbiota. I.e. a quantitative measure Copies/mL.(Examined longitudinally throughout the segmentation cycle. The estimated time to event is 40 days from oocyte retrieval until frozen embryo transfer following a strict protocol.)
- Number of participants with a Live birth(36-42 weeks after inclusion)
研究者
Peter Humaidan
Professor
Regionshospitalet Viborg, Skive