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

Stopped early · Not applicable

Conditions studied: Infertility of Uterine Origin

In brief

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.

Key facts

Study ID

NCT03530254

Run by

Igenomix

People needed

368

Starts

2018-05-28

Expected to finish

2022-02-22

Last updated by the study team

2022-05-04

Who can join

Age: any. Sex: female. Healthy volunteers: not accepted.

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…

• Presence of pathologies or malformations that affect the uterine cavity such as polyps, intramural myomas ≥ 4cm or submucosal, septum or hydrosalpinx during the patient's participation in the study. Patients suffering these pathologies before or after their inclusion in the study are allowed to participate if the pathology is corrected before performing any study procedure.
• 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.

Where it is running

• Ovation Fertility Newport Beach — Newport Beach, California, United States
• Fertility Centers of New England — Reading, Massachusetts, United States
• Pregna Medicina Reproductiva — CABA, Argentina
• Vida Bem Vinda — São Paulo, Brazil
• Olive Fertility Center — Vancouver, Canada
• Shady Grove Fertility Chile — Vitacura, Chile
• Georgian- American Center for Reproductive Medicine ReproART — Tbilisi, Georgia
• OASIS centre for reproductive medicine — Banjara Hills, Hyderabad, India
• Mother And Child Hospital — Defence Colony, National Capital Territory of Delhi, India
• NASCERE — Mexico City, Mexico City, Mexico
• Milenium Centro Médico y de Bienestar de Alcobendas - Sanitas — Alcobendas, Madrid, Spain
• Instituto Extremeño de Reproducción Asistida S.L. (IERA) — Badajoz, Spain
• Taiwan IVF Group — Zhubei, Taiwan
• Bahceci Group — Istanbul, Turkey (Türkiye)
• Vinmec Time City International Hospital — Hà Nội, Vietnam

Full record on ClinicalTrials.gov

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