Microbiota in patients with unexplained infertility and repeated implantation failure
- Conditions
- Health Condition 1: O00-O9A- Pregnancy, childbirth and the puerperium
- Registration Number
- CTRI/2024/08/072365
- Lead Sponsor
- All India Institute of Medical Sciences New Delhi
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
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
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
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method •To characterize the microbiota from endometrial fluid samples in fertile Indian women during the widow of implantation <br/ ><br>•To compare the endometrial microbiota in women with RIF and unexplained infertility with microbiota from fertile age matched women during the window of implantation. <br/ ><br>Timepoint: Baseline sample only
- Secondary Outcome Measures
Name Time Method To characterize the microbiota from endometrial fluid samples in fertile Indian women during the widow of implantation <br/ ><br>•To compare the endometrial microbiota in women with RIF and unexplained infertility with microbiota from fertile age matched women during the window of implantation. <br/ ><br>Timepoint: 0-12 monthsRecruitment of subjects <br/ ><br>3-10 monthsCollection of endometrial samples and transport for metagenomic analysis <br/ ><br>9-12 monthsAnalysis and interpretation of results <br/ ><br>