International Non-selection Study for ERA® Test in Patients With Previous Implantation Failures

Active, not recruitingOBSERVATIONAL
Enrollment

738

Participants

Timeline

Start Date

January 16, 2024

Primary Completion Date

April 30, 2026

Study Completion Date

December 31, 2026

Conditions
Infertility of Uterine OriginImplantation Failure
Interventions
DIAGNOSTIC_TEST

Endometrial fluid and biopsy collection

"The ERA and EMMA test require an endometrial biopsy to be taken at P+5 (after 120±6 hours of exogenous progesterone administration) in a HRT cycle, according to the common clinical practice. On the same day, a sample of endometrial fluid will be aspirated immediately prior to the biopsy.~Regardless of the endometrial receptivity profile, a subsequent regular FET will be performed within the standard WOI (after 120±6 hours of progesterone exposure) in an HRT cycle following the clinical standard practice.~Those patients willing to participate in the rescue phase will follow the recommendation of the ERA test for the subsequent pET."

DIAGNOSTIC_TEST

Endometrial fluid and biopsy collection

"The ERA and EMMA test require an endometrial biopsy to be taken at P+5 (after 120±6 hours of exogenous progesterone administration), according to the common clinical practice. On the same day, a sample of endometrial fluid will be aspirated immediately prior to the biopsy.~Regardless of the endometrial receptivity profile, a subsequent regular FET will be performed within the standard WOI (after 120±6 hours of progesterone exposure) in an HRT cycle following the clinical standard practice.~Those patients willing to participate in the rescue phase will follow the recommendation of the ERA test for the subsequent pET. In case of a non-receptive endometrium result, a second EB sample must be collected when indicated by the ERA report. Fluid sample collection will not be repeated in these cases."

Trial Locations (8)

15036

Inmater, San Borja

28035

Ovoclinic Madrid, Madrid

29016

URE Centro Gutenberg, Málaga

29603

Ovoclinic Marbella, Marbella

41092

Vida Recoletas Sevilla, Seville

47004

Vida Recoletas Valladolid, Valladolid

C1058 AAL

In Vitro Buenos Aires, Buenos Aires

Unknown

The Fertile Group, Panama City

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Igenomix

INDUSTRY

NCT06097559 - International Non-selection Study for ERA® Test in Patients With Previous Implantation Failures | Biotech Hunter | Biotech Hunter