Pregnancy Clinical Trial
— SetDetPgtOfficial title:
Single or Double Elective Embryos Transfer Associated to Preimplantation Genetic Test in in Vitro Fertilization Cycles
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.
Status | Recruiting |
Enrollment | 400 |
Est. completion date | December 31, 2022 |
Est. primary completion date | August 31, 2022 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years to 37 Years |
Eligibility | Inclusion Criteria: - 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 Exclusion Criteria: - 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. |
Country | Name | City | State |
---|---|---|---|
Brazil | Faculdade de Medicina da Universidade de São Paulo (FMUSP) | Sao Paulo | SP |
Lead Sponsor | Collaborator |
---|---|
University of Sao Paulo General Hospital |
Brazil,
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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