Development of a Microbiome Non-invasive Diagnosis Tool

CompletedOBSERVATIONAL
Enrollment

452

Participants

Timeline

Start Date

August 4, 2017

Primary Completion Date

May 17, 2019

Study Completion Date

June 25, 2020

Conditions
Infertility of Uterine Origin
Interventions
PROCEDURE

Endometrial biopsy and endometrial fluid collection

On the same day that the EB for ERA is indicated, in day 5 of a HRT cycle with 5 days of progesterone, according to the common clinical practice, a sample of EF will be aspirated immediately prior to EB for ERA. This EF sample will be used for the non-invasive diagnosis of the microbiome, also a small portion of the endometrial tissue obtained for the endometrial receptivity diagnosis by ERA will be used as a control for the study of the endometrial microbiome. Those patients with a receptive endometrium will continue their ART according to the standard clinical protocol. Those patients with non-receptive endometrium will follow the recommendation derived of the ERA test for the election of the day for a second EB sample, in which the collection of EF sample will be repeated. Finally, the receptivity and microbiome results in EF will be correlated with that on the endometrial tissue, and with the reproductive outcomes of these patients after the embryo transfer.

Trial Locations (13)

11000

New Hope Fertility Center, Mexico City

22203

Dominion Fertility, Arlington

28036

ProcreaTec, Madrid

29640

Clinica Fertia, Fuengirola

33063

IVF Florida, Margate

47810

Alpha Fertility Center, Petaling Jaya

63005

Missouri Center for Reproductive Medicine (MCRM Fertility), Chesterfield

06861

RMA Connecticut, Norwalk

Unknown

Gestanza Medicina Reproductiva, Rosario

Bahçeci Fulya IVF Center, Istanbul

C1425DGQ

Pregna Medicina Reproductiva, Buenos Aires

V5G 4X7

Pacific Center for Reproductive Medicine, Burnaby

557-0045

oak Clinic Sumiyoshi, Osaka

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Igenomix

INDUSTRY

NCT03330444 - Development of a Microbiome Non-invasive Diagnosis Tool | Biotech Hunter | Biotech Hunter