eSET or eDET Associated to PGT in IVF

NCT03758833 | Completed DMC

• 1 other identifier: SET-NGS
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

in vitro fertilization; single embryo transfer; preimplantation genetic diagnosis; clinical pregnancy

Outcome Measures

Primary Outcomes (1)

• cumulative pregnancy rate

  percentage of patients who become pregnant after transfer of embryos

  6 months

Secondary Outcomes (4)

• cycle cancellation rate

  1 month

• multiple pregnancy rate

  6 months

• live birth rates

  one year

• transfers needed to achieve gestation

  6 months

Study Arms (4)

SET

ACTIVE COMPARATOR

patients receiving the elective single embryo transfer

Procedure: Single embryo transfer

SET+NGS

EXPERIMENTAL

patients receiving the elective single embryo transfer evaluated genetically by NGS

Diagnostic Test: preimplantation genetic test of embryo by new generation sequencing (NGS); Procedure: Single embryo transfer

DET

ACTIVE COMPARATOR

patients receiving the elective double embryo transfer

Procedure: Double embryo tranfer

DET+NGS

EXPERIMENTAL

patients receiving the elective double embryo transfer evaluated genetically by NGS

Diagnostic Test: preimplantation genetic test of embryo by new generation sequencing (NGS); Procedure: Double embryo tranfer

Interventions

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

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

DET+NGS; SET+NGS

Single embryo transfer PROCEDURE

Transfer of single embryo

Also known as: SET

SET; SET+NGS

Double embryo tranfer PROCEDURE

Transfer of two embryos

Also known as: DET

DET; DET+NGS

Eligibility Criteria

• Age: 18 Years - 37 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Couples performing in vitro fertilization cycles using intracytoplasmic sperm injection
• Performing the first treatment cycle;
• Body Mass Index (BMI) of 18 to 30 kg / m2;
• Presence of both ovaries without evidence of significant abnormalities;
• Absence of any significant pathology of the endometrial cavity, such as polyps, fibroids larger than 4cm and hidrosalpinge;
• Normal ovarian reserve, determined by antral follicle count\> 8 and FSH \<12 mIU / mL;
• Use of fresh ejaculate or cryopreserved partner seminal sample

You may not qualify if:

• Women presenting endometriosis degrees III and IV;
• Sperm used for fertilization from partner with severe oligozoospermia (\<5 million sperm / ml);
• Women with associated systemic diseases or infectious diseases;
• Do not have at least two good quality blastocysts on the fifth day of development.

Sponsors & Collaborators

• University of Sao Paulo General Hospital: lead

Study Sites (1)

Faculdade de Medicina da Universidade de São Paulo (FMUSP)

São Paulo, São Paulo, Brazil

Location

MeSH Terms

Interventions

Single Embryo Transfer; DEET

Intervention Hierarchy (Ancestors)

Embryo Transfer; Reproductive Techniques, Assisted; Reproductive Techniques; Therapeutics; Investigative Techniques; Benzamides; Amides; Organic Chemicals; Benzoates; Acids, Carbocyclic; Carboxylic Acids; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Head of the Reproductive Medicine Center Governador Mario Covas

Study Record Dates

• First Submitted: November 28, 2018
• First Posted: November 29, 2018
• Study Start: November 20, 2018
• Primary Completion: December 1, 2022
• Study Completion: May 5, 2024
• Last Updated: July 3, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)