Endometrial Flora in Women Undergoing IVF Treatments

Endometrial Flora Sampling in Women Undergoing IVF/PGD Treatments

Characterization of the female genital tract microbiome in women undergoing IVF treatment

Study Overview

• Status: Unknown
• Conditions: Endometrial Flora Characterization in Infertile Women
• Intervention / Treatment: Diagnostic test: Endometrial sampling of a Typical Embryo transfer catheter

Detailed Description

The primary goal With The purpose of our study is to examine the uterine microbiome by Next-generation sequencing of the bacteria specific regions .

Vaginal and uterine swabs will be taken in different women undergoing IVF /PGD. Novel bacteria and results of taxonomy assignments will be examine to find correlation of uterine flora with IVF and obstetrical outcomes.

The metagenomics approach will be used to seek previously unidentified bacterial species in the human upper genital tract.

• Study Type: Observational
• Enrollment (Anticipated): 150

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 45 years (Adult)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: Female

• Sampling Method: Non-Probability Sample

Study Population

patients undergoing transfer of a single euploid blastocyst .The specimen will be obtaine from the embryo transfer catheter.

Description

Inclusion Criteria:

• All undergoning IVF treatment
• Embryo transfer of one Blastocyst

Exclusion Criteria:

• More then one Embryo Transfer
• Recent antibacterial treatment

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
To assess endometrial caracteristicas in fertile and infertile women using next generation sequencing of bacterial identification	Type of flora identified by next generation sequencing of bacterial identification	2017-2020
To identify specific endometrial flora in association to faliure of IVF treatment	Type of flora identified by NGS	2017-2020
to assess the feasibility of endometrial sampling in women undergoing embryo transfer by a standart transfer cateteher	Mode of endometrial sampling	2017-2020

Collaborators and Investigators

• Sponsor: Tel-Aviv Sourasky Medical Center

Study record dates

Study Major Dates

• Study Start (Anticipated): August 1, 2017
• Primary Completion (Anticipated): August 1, 2020
• Study Completion (Anticipated): August 1, 2020

Study Registration Dates

• First Submitted: June 26, 2017
• First Submitted That Met QC Criteria: July 3, 2017
• First Posted (Actual): July 5, 2017

Study Record Updates

• Last Update Posted (Actual): July 5, 2017
• Last Update Submitted That Met QC Criteria: July 3, 2017
• Last Verified: June 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Infertility
• Other Study ID Numbers: 0201-17

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No