The ERA Test as a Diagnostic Guide for Personalized Embryo Transfer

NCT01954758 | Completed

• 1 other identifier: 1304-C-107-CS
• Study Type: interventional
• Target: 569
• Locations: 7 countries
• Sites: 16

Brief Summary

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

Conditions

Endometrial Receptivity

Keywords

Window of implantation; Personalized embryo transfer; Fresh embryo transfer; Delayed embryo transfer; Elective deferred embryo transfer; Endometrial receptivity array; Endometrial receptivity analysis; Endometrial receptivity test; Frozen embryo transfer

Outcome Measures

Primary Outcomes (1)

• Live birth delivery rate

  Percentage of deliveries that resulted in at least one live birth per embryo transfer.

  40 weeks

Secondary Outcomes (8)

• Implantation rate

  12 weeks

• Pregnancy rate

  20 weeks

• Biochemical pregnancies

  20 weeks

• Ectopic pregnancies

  20 weeks

• Clinical miscarriages

  20 weeks

Study Arms (3)

Personalized embryo transfer (pET)

EXPERIMENTAL

Patients will undergo a cycle of endometrial preparation following hormone replacement therapy (HRT) and an endometrial biopsy in a substituted cycle after 5 days (around 120 hours) of progesterone administration. The ERA test will determine the window of implantation (WOI) for each patient and will recommend the best time for embryo transfer thereby increasing the chances of a successful outcome. In some specific cases (≤ 10%) a second biopsy will be required to help the bioinformatic predictor to ensure the most appropriated moment for the embryo transfer. In a different cycle, patients will undergo a cycle of controlled ovarian stimulation (COS) to obtain oocytes which will be fertilized by IVF/ICSI and vitrified. In a subsequent cycle, following the ERA result, a personalized embryo transfer (pET) will be carried out following the same conditions in which the ERA test was obtained, using 1 or 2 viable blastocysts previously obtained (day 5 or 6 stage)

Other: personalized Embryo Transfer (pET)

Frozen embryo transfer (FET)

ACTIVE COMPARATOR

Patients will undergo a cycle of controlled ovarian stimulation (COS) to obtain oocytes which will be fertilized by IVF/ICSI. In a subsequent cycle, following hormone replacement therapy (HRT), a frozen embryo transfer (FET) will be performed using 1 or 2 viable blastocysts previously obtained (day 5 or 6 stage).

Other: Frozen Embryo Transfer (FET)

Fresh embryo transfer (ET)

ACTIVE COMPARATOR

Patients will undergo a controlled ovarian stimulation cycle (COS) to obtain oocytes which will be fertilized by IVF/ICSI. In the same cycle, a fresh embryo transfer will be performed using 1 or 2 viable blastocysts previously obtained (day 5 or 6 stage).

Other: Fresh Embryo Transfer (ET)

Interventions

personalized Embryo Transfer (pET) OTHER

Personalized embryo transfer (pET)

Frozen Embryo Transfer (FET) OTHER

Frozen embryo transfer (FET)

Fresh Embryo Transfer (ET) OTHER

Fresh embryo transfer (ET)

Eligibility Criteria

• Age: 18 Years - 37 Years
• Gender Eligibility Details: Women undergoing IVF treatment
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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)
• 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).

Sponsors & Collaborators

• Igenomix: lead

Study Sites (16)

Centre of Reproductive Medicine UZ Brussles

Brussels, 1090, Belgium

Location

Centro de Infertilidade e Medicina Fetal do Norte Fluminence

Campos dos Goytacazes, Rio de Janeiro, 28035-210, Brazil

Location

Centro de Reproduçao Humana Nilo Frantz

Porto Alegre, Rio Grande do Sul, Brazil

Location

Centro de Reprodução Governador Mario Covas

São Paulo, Brazil

Location

Sofia Hospital of Reproductive Medicine - SBALAGRM

Sofia, 1000, Bulgaria

Location

Oak Clinic Sumiyoshi

Osaka, 557-0045, Japan

Location

IVI Panama

Panama City, 0819, Panama

Location

IVI Bilbao

Leioa, Bizkaia, 48940, Spain

Location

IVI Madrid

Aravaca, Madrid, 24527, Spain

Location

IVI Vigo

Vigo, Pontevedra, 36203, Spain

Location

IVI Alicante

Alicante, 03015, Spain

Location

IVI Barcelona

Barcelona, 08017, Spain

Location

ProcreaTec

Madrid, 28036, Spain

Location

IVI Sevilla

Seville, 41011, Spain

Location

IVI Valencia

Valencia, 46015, Spain

Location

Bahceci Health Group

Istanbul, 34500, Turkey (Türkiye)

Location

Related Publications (1)

• Katzorke N, Vilella F, Ruiz M, Krussel JS, Simon C. Diagnosis of Endometrial-Factor Infertility: Current Approaches and New Avenues for Research. Geburtshilfe Frauenheilkd. 2016 Jun;76(6):699-703. doi: 10.1055/s-0042-103752.

  PMID: 27365540 DERIVED

Study Officials

• Carlos Simon, MDPhD

  IVI Valencia / Igenomix

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Scientific Director IGENOMIX; Gynaecologist IVI Valencia

Study Record Dates

• First Submitted: September 26, 2013
• First Posted: October 7, 2013
• Study Start: November 25, 2013
• Primary Completion: August 31, 2018
• Study Completion: August 31, 2018
• Last Updated: February 27, 2019

Record last verified: 2019-02

Locations

ES (8); JP (1); BU (1); BE (1); PA (1); TU (1); BR (3)