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Endometrial Flora in Women Undergoing IVF Treatments

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ClinicalTrials.gov Identifier: NCT03208595
Recruitment Status : Unknown
Verified June 2017 by michal roll, Tel-Aviv Sourasky Medical Center.
Recruitment status was:  Not yet recruiting
First Posted : July 5, 2017
Last Update Posted : July 5, 2017
Sponsor:
Information provided by (Responsible Party):
michal roll, Tel-Aviv Sourasky Medical Center

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

Condition or disease Intervention/treatment
Endometrial Flora Characterization in Infertile Women 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.

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Study Type : Observational
Estimated Enrollment : 150 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Endometrial Flora Sampling in Women Undergoing IVF/PGD Treatments
Estimated Study Start Date : August 1, 2017
Estimated Primary Completion Date : August 1, 2020
Estimated Study Completion Date : August 1, 2020

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


Primary Outcome Measures :
  1. To assess endometrial caracteristicas in fertile and infertile women using next generation sequencing of bacterial identification [ Time Frame: 2017-2020 ]
    Type of flora identified by next generation sequencing of bacterial identification

  2. To identify specific endometrial flora in association to faliure of IVF treatment [ Time Frame: 2017-2020 ]
    Type of flora identified by NGS

  3. to assess the feasibility of endometrial sampling in women undergoing embryo transfer by a standart transfer cateteher [ Time Frame: 2017-2020 ]
    Mode of endometrial sampling


Biospecimen Retention:   Samples With DNA
Bacterial DNA only


Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   All infertile women
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.
Criteria

Inclusion Criteria:

  • All undergoning IVF treatment
  • Embryo transfer of one Blastocyst

Exclusion Criteria:

  • More then one Embryo Transfer
  • Recent antibacterial treatment
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Responsible Party: michal roll, Deputy Director General for R&D, Tel-Aviv Sourasky Medical Center
ClinicalTrials.gov Identifier: NCT03208595    
Other Study ID Numbers: 0201-17
First Posted: July 5, 2017    Key Record Dates
Last Update Posted: July 5, 2017
Last Verified: June 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Infertility