Endometrial Flora in Women Undergoing IVF Treatments

Endometrial Flora Characterization in Infertile Women Clinical Trial

Official title:

Endometrial Flora Sampling in Women Undergoing IVF/PGD Treatments

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03208595
• Other study ID #: 0201-17
• Status: Not yet recruiting
• Phase: N/A
• First received: June 26, 2017
• Last updated: July 3, 2017
• Start date: August 1, 2017
• Est. completion date: August 1, 2020

Study information

• Verified date: June 2017
• Source: Tel-Aviv Sourasky Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 150
• Est. completion date: August 1, 2020
• Est. primary completion date: August 1, 2020
• Gender: Female
• Age group: 20 Years to 45 Years

Eligibility

Inclusion Criteria:

• All undergoning IVF treatment

• Embryo transfer of one Blastocyst

Exclusion Criteria:

• More then one Embryo Transfer

• Recent antibacterial treatment

Related Conditions & MeSH terms

• Endometrial Flora Characterization in Infertile Women

Intervention

Diagnostic Test:
• Endometrial sampling of a Typical Embryo transfer catheter
no intervention no additional change from unit protocol

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Tel-Aviv Sourasky Medical Center

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	To identify specific endometrial flora in association to faliure of IVF treatment	Type of flora identified by NGS	2017-2020
Primary	to assess the feasibility of endometrial sampling in women undergoing embryo transfer by a standart transfer cateteher	Mode of endometrial sampling	2017-2020