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)

Igenomix16 sites in 7 countries569 target enrollmentNovember 25, 2013

ConditionsEndometrial Receptivity

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Endometrial Receptivity
Sponsor: Igenomix
Enrollment: 569
Locations: 16
Primary Endpoint: Live birth delivery rate
Status: Completed
Last Updated: 7 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief 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.

Registry

clinicaltrials.gov

Start Date

November 25, 2013

End Date

August 31, 2018

Last Updated

7 years ago

Study Type

Interventional

Study Design

Parallel

Sex

Female

Investigators

Sponsor

Igenomix

Responsible Party

Principal Investigator

Carlos Simon

Scientific Director IGENOMIX; Gynaecologist IVI Valencia

Instituto Valenciano de Infertilidad, IVI VALENCIA

Eligibility Criteria

Inclusion Criteria

•Patients indicated to undergo a cycle of IVF/ICSI with their own oocytes.
•Age ≤ 37 years
•BMI: 18.5 to 30
•Normal ovarian reserve (AFC ≥ 8; FSH \< 8)
•The most appropriated stimulation protocol will be decided by their doctor.
•Blastocyst transfer (on day 5 or 6)
•Blastocyst vitrification with open protocols (Cryotop, Cryoleaf, or Cryolock) or closed protocols (Cryotip or CBSStraw.)
•Any pathology affecting the endometrial cavity such as polyps/sub-mucosal myomas, intramural myomas \> 4 cm, or hydrosalpinx affecting the endometrial cavity must be previously operated.

Exclusion Criteria

•Patients with recurrent miscarriages (\> 2 previous biochemical pregnancies or \> 2 spontaneous miscarriages)
•Patients with a severe male factor (spermatozoa \< 2 million/ml)
•Patients with implantation failure (\>3 failed cycles with good quality embryos)
•Post-Randomization Exclusion Criteria:
•Endogenous progesterone level ≥ 1,5 ng/ml at the day of hCG administration in all groups.
•Absence of blastocysts (day 5 or 6) for embryo transfer.
•Risk of ovarian hyperstimulation syndrome in any of the three groups and therefore a clinical indication to cancel the transfer cycle where the stimulated patient is from group A (ET).
•Note: PGT-A is not an inclusion criteria neither an exclusion criteria, therefore those cycles in which PGT-A was performed will be included