eSET or eDET Associated to PGT in IVF

Summary

In vitro fertilization (IVF) techniques have been improving performance recently and, nowadays, provide a live birth rate of around 25%. The success of IVF techniques is dependent upon maximum efficiency at each stage of treatment, and, at the same time, high success rates with a low risk of complications. Multiple pregnancies are one of the most important adverse event of IVF techniques. In this sense, the use of elective single embryo transfer (SET) has become an option for patients with good prognosis compared to the transfer of multiple embryos, and it is recommended in order to reduce the risk of multiple pregnancies and their consequences. On the other hand, it is known that embryonic quality is a crucial step for the success of IVF techniques and the efficiency of this process is linked to the decrease in the number of embryos to be transferred. Usually, embryo selection is based on morphological and developmental criteria. However, recently, it has been demonstrated that the blastocyst biopsy associated with the chromosomal / genetic screening may be a predictor of the chances of implantation. The investigators group demonstrated the feasibility of performing SET sequentially, promoting satisfactory gestation rates and safety for the mother and baby regarding multiple gestation for patients with good prognosis. Based on these principles, the investigators raised the hypothesis that SET associated with preimplantation genetic diagnosis (PGD) by next-generation sequencing (NGS) for patients with good prognosis can improve the success rates of IVF cycles and, at the same time, avoid multiple pregnancies, as well as maternal-fetal and neonatal risks resulting from this condition. To test this hypothesis, the aim of this study is to compare the results of IVF treatments in patients receiving SET (SET group), SET associated with genetic evaluation by NGS (group NGS + SET), elective transference of two embryos (DET group) and DET associated with genetic evaluation by NGS (NGS + DET). In case of non-pregnancy on the first transfer, there will be subsequent transfers until the remaining embryos are exhausted or the patient reaches the gestation. The primary endpoint will be the cumulative pregnancy rate per treatment cycle and this approach will allow to confirm or not the hypothesis that genetic analysis is effective in improving the embryo selection process and associated with SET will increase clinical gestation rates and decrease rates of multiple gestations and miscarriages.

Conditions

• in Vitro Fertilization
• Single Embryo Transfer
• Preimplantation Genetic Diagnosis
• Pregnancy

Interventions

DIAGNOSTIC_TEST

preimplantation genetic test of embryo by new generation sequencing (NGS)

This is a genetic test to evaluate 24 chromosomes by the new generation sequencing platform. For that is necessary a embryo biopsy in the blastocyst stage and evaluation of a greater number of cells extracted from the trophectoderm

PROCEDURE

Single embryo transfer

Transfer of single embryo

PROCEDURE

Double embryo tranfer

Transfer of two embryos

Sponsors & Collaborators

• University of Sao Paulo General Hospital

  lead OTHER

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

37 Years

Sex

FEMALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2018-11-20

Primary Completion

2022-12-01

Completion

2024-05-05

Countries

• Brazil

Study Locations