NCT03214185

Effects of PGS2.0 in Patients With Unexplained RPL

Effects of Preimplantation Genetic Screening 2.0 on the Clinical Outcomes of Assisted Reproductive Treatment in Patients With Recurrent Pregnancy Loss : A Multi-center-based Prospective Randomized Clinical Trial

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 710 (estimated)
• Sponsor: ShangHai Ji Ai Genetics & IVF Institute · Academic / Other
• Sex: Female
• Age: 20 Years – 37 Years
• Healthy volunteers: Not accepted

Summary

50%-60% of the known causes of recurrent pregnancy loss(RPL) are associated with embryonic aneuploidy, such that preimplantation genetic screening (PGS) on embryos acquired by assisted reproductive treatment should improve the rate of pregnancy and live birth in those patients. In dispute though the clinical application of PGS has been, a series of studies show that the new generation of PGS(PGS 2.0), based on blastocyst biopsy followed by whole genome analysis, has significantly improved the clinical outcome of IVF treatment. At present, there is still a need for the evidence of the use of PGS 2.0 in RPL patients, who may benefit from this emerging technology considering the prevalence of genetic abnormalities and the number of transferable embryos in this population. An earlier single center RCT conducted by our IVF center displayed higher implantation rate, clinical pregnancy rate and ongoing pregnancy rate calculated by per embryo transfer(ET) cycle in IVF/ICSI+PGS group compared with IVF/ICSI group. This multi-center prospective randomized clinical trial is to provide more data to determine whether the clinical outcomes are significantly improved per treatment cycle such that provide evidence for the application of PGS in RPL patients. Besides, risk factors of PGS outcome are to be analyzed from multi-center data to build a model for prediction of the possible outcomes of PGS and direction of the clinical choice.

Conditions

• Recurrent Pregnancy Loss
• Infertility, Female

Interventions

Type	Name	Description
PROCEDURE	IVF/ICSI	in vitro fertilization or intracytoplasmatic sperm injection
GENETIC	PGS 2.0	Blastocysts are selected by PGS 2.0(NGS based) and only euploid embryos will be transferred.
OTHER	Conventional embryo morphology evaluation	Blastocysts are selected by morphology criteria and only good-scored embryo will be transferred.

Timeline

• Start date: 2018-02-06
• Primary completion: 2020-09-30
• Completion: 2021-09-30
• First posted: 2017-07-11
• Last updated: 2018-02-06

Locations

1 site across 1 country: China