Characterization of the uterine microbiota from women with unexplained infertility and recurrent implantation failure planned for in-vitro-fertilization (IVF)- a pilot study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 45
- 试验地点
- 1
- 主要终点
- •To characterize the microbiota from endometrial fluid samples in fertile Indian women during the widow of implantation
研究概览
简要总结
Infertilty affects almost 10 percent of the population with 30 percent cases being unexplained where despite doing a battery of investigations no cause is identified. While the quality of embryo can be ensured by techniques like Preimplantation Genetic testing, the quality of endometrium is a big challenge. The process of implantation is an immune mediated process with upregulation and downregulation of various mediators and receptors. Bacteria is known to affect immunity. Human microbiome Project has mapped the microbiota of various body sites including vagina. But the upper reproductive tract is not extensively studied. The concept of sterile womb is outdated as recent data suggests presence of commensals in endometrium. As the gut microbiota regulates immunity, extrapolating the same finding to endometrium compels us to study the role of uterine microbiota in immunity further affecting implantation. The present study aims to define the natural microbiota of fertile Indian females and compare it with infertile females and females with recurrent implantation failure. This will further help in unravelling this mysterious entity of recurrent implantation failure which despite immunotherapies fails to provide successful results.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 20.00 Year(s) 至 35.00 Year(s)（—）
- 性别
- Female
入选标准
- •Group1 Inclusion (Fertile controls) i.Healthy oocyte donors aged 20-35 years ii.Willing to participate in the study Group 2 (Unexplained Infertility) Women age 20-35 years and willing to participate in the study Group 3 ( Recurrent implantation failure ) i.Women undergoing 2 failed fresh or frozen transfer of good quality embryos ii.Women aged 20-36 years iii.
- •Willing to participate in the study.
排除标准
- •Group 1 (Fertile controls) i.On any hormone therapy including oral contraceptive ii.On recent use of antibiotics or probiotic therapy iii.With immune disorders including SLE, Rheumatoid arthritis Group 2 ( Unexplained infertility) i.On any hormone therapy including oral contraceptive ii.On recent use of antibiotics or probiotic therapy iii.Severe male factor infertility iv.Endometriosis in female v.Tubal factor and or presence of hydrosalpinges on HSG/ USG vi.Endometrial TB vii.
- •Sub-mucous fibroids or polyp Group 3 ( Recurrent implantation failure) i.On any hormone therapy including oral contraceptive ii.On recent use of antibiotics or probiotic therapy iii.Women with endometriosis, tubal factor infertility iv.Endometrial TB v.
- •Sub-mucous fibroids or polyp vi.Uterine adenomyosis vii.Unwilling to participate in study.
结局指标
主要结局
•To characterize the microbiota from endometrial fluid samples in fertile Indian women during the widow of implantation
时间窗: Baseline sample only
•To compare the endometrial microbiota in women with RIF and unexplained infertility with microbiota from fertile age matched women during the window of implantation.
时间窗: Baseline sample only
次要结局
- To characterize the microbiota from endometrial fluid samples in fertile Indian women during the widow of implantation(•To compare the endometrial microbiota in women with RIF and unexplained infertility with microbiota from fertile age matched women during the window of implantation.)