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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03758833
Other study ID # SET-NGS
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date November 20, 2018
Est. completion date December 31, 2022

Study information

Verified date May 2022
Source University of Sao Paulo General Hospital
Contact Pedro Monteleone, MD, PhD
Phone +55 11 98354-9972
Email pedro@monteleone.med.br
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Description:

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Study Design


Related Conditions & MeSH terms


Intervention

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
Double embryo tranfer
Transfer of two embryos

Locations

Country Name City State
Brazil Faculdade de Medicina da Universidade de São Paulo (FMUSP) Sao Paulo SP

Sponsors (1)

Lead Sponsor Collaborator
University of Sao Paulo General Hospital

Country where clinical trial is conducted

Brazil, 

Outcome

Type Measure Description Time frame Safety issue
Primary cumulative pregnancy rate percentage of patients who become pregnant after transfer of embryos 6 months
Secondary cycle cancellation rate percentage of cycles cancelled due to all embryos genetic alterated 1 month
Secondary multiple pregnancy rate percentage of patients who become pregnant of twins 6 months
Secondary live birth rates percentage of patients who had live birth one year
Secondary transfers needed to achieve gestation number of embryos transfers needed to achieve gestation 6 months
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