NCT01954758

The ERA Test as a Diagnostic Guide for Personalized Embryo Transfer

Clinical Study, International, Multicentre, Prospective, Randomised, Interventional and Controlled, Comparing Fresh Embryo Transfer (ET) Versus Frozen Embryo Transfer (FET) and Personalised Embryo Transfer (pET) Guided by the ERA (Endometrial Receptivity Analysis) Test as a Diagnostic Tool in Patients Treated by IVF/ICSI (in Vitro Fertilisation; Intra-cytoplasmic Sperm Injection)

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 569 (actual)
• Sponsor: Igenomix · Industry
• Sex: Female
• Age: 18 Years – 37 Years
• Healthy volunteers: Not accepted

Summary

This project seeks to demonstrate the clinical value of the personalised diagnosis of the endometrial factor in infertility.

Detailed description

This project seeks to investigate differences in implantation (IR), pregnancy (PR), ongoing pregnancy (OP) rates, miscarriages, deliveries (LB) and obstetrical, delivery and neonatal outcomes among women undergoing IVF treatment with own oocytes, at first site appointment (up to 3 previous implantation failures in other sites) and blastocyst stage (day 5 or 6). Patients are allocated through computer-generated randomization into one of the three groups: Fresh embryo transfer (ET), Frozen embryo transfer (FET) or personalized embryo transfer (pET) after identification of the personalized window of implantation using the endometrial receptivity analysis (ERA) test, all of them following the usual clinical practice in a same-cycle embryo transfer. A total of 546 infertile women under 38 years old undergoing her first IVF/ICSI cycle with elective blastocyst transfer are randomized in this prospective, multicenter, open label and controlled trial.

Conditions

• Endometrial Receptivity

Interventions

Type	Name	Description
OTHER	personalized Embryo Transfer (pET)
OTHER	Frozen Embryo Transfer (FET)
OTHER	Fresh Embryo Transfer (ET)

Timeline

• Start date: 2013-11-25
• Primary completion: 2018-08-31
• Completion: 2018-08-31
• First posted: 2013-10-07
• Last updated: 2019-02-27

Locations

16 sites across 7 countries: Belgium, Brazil, Bulgaria, Japan, Panama, Spain, Turkey (Türkiye)