Clinical Study of PGT-A Versus PGT-A+ERA

NCT03530254 | Terminated

• 1 other identifier: IGX1-P&E-DV-17-08
• Study Type: interventional
• Target: 368
• Locations: 12 countries
• Sites: 15

Brief Summary

Patients who have shown previous implantation failures, despite transferring good quality and chromosomally normal embryos (diagnosed by PGT-A), could have a displaced Window of Implantation (WOI) and consequently, alterations in their endometrial receptivity. The correction of this displacement can improve the results of the Assisted Reproduction Treatments (ART). The ERA test (Endometrial Receptivity Analysis) evaluates the transcriptomic endometrial profile to determine if the patient's uterus is receptive when the embryo is transferred during an In Vitro Fertilization (IVF) process, and identifies the personalized WOI of the patient. This process is called Personalized Embryo Transfer (pET). The Preimplantation Genetic Test of Aneuploidies or PGT-A (Preimplantation Genetic Testing for Aneuploidy), is currently carried out using Next Generation Sequencing (NGS) and serves to identify chromosomally normal embryos prior to their transfer in an IVF treatment. Aneuploidies are rarely compatible with life or can cause congenital diseases. So, the identification of chromosomally normal embryos, improves the success of reproduction in cases in which infertility is caused by such aneuploidies. Therefore, the aim of this study is to determine, in a randomized and prospective way, the clinical benefit of adding the ERA test to the embryonic aneuploidies test for patients with a PGT-A indication.

Conditions

Infertility of Uterine Origin

Keywords

Endometrial receptivity; Preimplantation Genetic Diagnosis (PGD); Preimplantation Genetic Testing for Aneuploidy (PGT-A); Embryo Transfer (ET); Endometrial Receptivity Analysis (ERA); Endometrial Diagnosis; Live Newborn Rate (LBR)

Outcome Measures

Primary Outcomes (1)

• Live birth rate

  Number of babies born per embryo transfer

  40 weeks

Secondary Outcomes (6)

• Implantation rate

  12 weeks

• Clinical pregnancy

  20 weeks

• Biochemical pregnancy

  20 weeks

• Clinical miscarriages

  20 weeks

• Ectopic pregnancies

  20 weeks

Study Arms (2)

PGT-A without ERA

OTHER

Patients with PGT-A indication and ET in a Hormone Replacement Therapy (HRT cycle) according to the usual clinical practice (day 5 of progesterone supplementation: P+5/120h).

Diagnostic Test: PGT-A

PGT-A and test ERA

OTHER

Patients with PGT-A indication and pET in HRT cycle following the ERA test indication (when the WOI is confirmed as "Receptive").

Diagnostic Test: PGT-A; Diagnostic Test: ERA Test

Interventions

PGT-A DIAGNOSTIC_TEST

PGT-A will be carried out following the usual clinical practice. Trophectoderm biopsy samples from blastocysts are analyzed by NGS to screen for numerical chromosomal abnormalities.

PGT-A and test ERA; PGT-A without ERA

ERA Test DIAGNOSTIC_TEST

The ERA test requires an endometrial biopsy and will determine if the endometrium is receptive or not by analysing the expression levels of 236 genes involved in endometrial receptivity, to assess the optimal time to place an embryo into the uterus and promote a successful implantation and pregnancy.

PGT-A and test ERA

Eligibility Criteria

• Gender Eligibility Details: Majority of age infertile patients who already have frozen euploids blastocysts (day 5/6 development) obtained from their own oocytes, fertilized by IFV/ICSI and analysed by PGT-A, with an expected embryo transfer of one or two embryos in a Hormone Replacement Therapy cycle (HRT cycle).
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Majority of age patients whose written informed consent approved by the Ethics Committee (EC) has been obtained, after having been duly informed of the nature of the study and voluntarily accepted to participate after being fully aware of the potential risks, benefits and any discomfort involved.
• Patients who already have frozen euploid blastocysts (day 5/6 development) analysed by PGT-A.
• Patients with embryos obtained from their own oocytes fertilized by Intracytoplasmic Sperm Injection (ICSI) or In vitro fertilization (IVF).
• Patients with an expected embryo transfer of one or two embryos (Single ET or Double ET) in a HRT cycle.
• Body Mass Index: 18,5-30 Kg/m2.

You may not qualify if:

• Any illness or medical condition that is unstable or which, according to medical criteria, may put at risk the patient's safety and her compliance in the study.

Sponsors & Collaborators

• Igenomix: lead

Study Sites (15)

Ovation Fertility Newport Beach

Newport Beach, California, 92663, United States

Location

Fertility Centers of New England

Reading, Massachusetts, 01867, United States

Location

Pregna Medicina Reproductiva

CABA, C1425, Argentina

Location

Vida Bem Vinda

São Paulo, 01332000, Brazil

Location

Olive Fertility Center

Vancouver, BC V5Z 3X7, Canada

Location

Shady Grove Fertility Chile

Vitacura, 6800, Chile

Location

Georgian- American Center for Reproductive Medicine ReproART

Tbilisi, 0179, Georgia

Location

OASIS centre for reproductive medicine

Banjara Hills, Hyderabad, 500034, India

Location

Mother And Child Hospital

Defence Colony, National Capital Territory of Delhi, 110024, India

Location

NASCERE

Mexico City, Mexico City, 05120, Mexico

Location

Milenium Centro Médico y de Bienestar de Alcobendas - Sanitas

Alcobendas, Madrid, 28108, Spain

Location

Instituto Extremeño de Reproducción Asistida S.L. (IERA)

Badajoz, 06006, Spain

Location

Taiwan IVF Group

Zhubei, 302, Taiwan

Location

Bahceci Group

Istanbul, 07720, Turkey (Türkiye)

Location

Vinmec Time City International Hospital

Hà Nội, Vietnam

Location

Study Officials

• Carlos Simón, MD PhD

  Igenomix

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 8, 2018
• First Posted: May 21, 2018
• Study Start: May 28, 2018
• Primary Completion: February 22, 2022
• Study Completion: February 22, 2022
• Last Updated: May 4, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will not share

Locations

VN (1); TW (1); AR (1); CL (1); GE (1); US (2); CA (1); ME (1); ES (2); IN (2); BR (1); TU (1)