MedPath

Microbiota in patients with unexplained infertility and repeated implantation failure

Not Applicable
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
Inclusion Criteria

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

Exclusion Criteria

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
NameTimeMethod
•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
NameTimeMethod
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>
© Copyright 2025. All Rights Reserved by MedPath