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Microbiota in patients with unexplained infertility and repeated implantation failure

Characterization of the uterine microbiota from women with unexplained infertility and recurrent implantation failure planned for in-vitro-fertilization (IVF)- a pilot study - NIL

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
CTRI
Registry ID
CTRI/2024/08/072365
Enrollment
45
Registered
2024-08-12
Start date
Unknown
Completion date
Unknown
Last updated
2024-08-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: O00-O9A- Pregnancy, childbirth and the puerperium

Interventions

Intervention1: nil: nil Control Intervention1: Fertile Controls : Healthy oocyte donors willing to participate in study will undergo one time sampling Control Intervention2: Unexplained Infertility

Sponsors

All India Institute of Medical Sciences New Delhi
Lead Sponsor

Eligibility

Inclusion criteria

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

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

Design outcomes

Primary

MeasureTime frame
•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. Timepoint: Baseline sample only

Secondary

MeasureTime frame
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. Timepoint: 0-12 months Recruitment of subjects 3-10 months Collection of endometrial samples and transport for metagenomic analysis 9-12 months Analysis and interpretation of results

Countries

India

Contacts

Public ContactNeena Malhotra

All India Institute of Medical Sciences

malhotraneena@yahoo.com9891557707

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026