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Clinical Trials/NCT03214185
NCT03214185
Unknown
Not Applicable

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

ShangHai Ji Ai Genetics & IVF Institute1 site in 1 country710 target enrollmentFebruary 6, 2018

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Recurrent Pregnancy Loss
Sponsor
ShangHai Ji Ai Genetics & IVF Institute
Enrollment
710
Locations
1
Primary Endpoint
Live birth rate per initiated cycle
Last Updated
8 years ago

Overview

Brief 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.

Registry
clinicaltrials.gov
Start Date
February 6, 2018
End Date
September 30, 2021
Last Updated
8 years ago
Study Type
Interventional
Study Design
Parallel
Sex
Female

Investigators

Sponsor
ShangHai Ji Ai Genetics & IVF Institute
Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

Live birth rate per initiated cycle

Time Frame: up to 42 days of a live birth

live birth rate of a baby per oocyte retrieval cycle initiated

Secondary Outcomes

  • Embryo implantation(2 weeks after embryo transfer)
  • Clinical pregnancy(4 weeks after embryo transfer)
  • Ongoing pregnancy(10 weeks after embryo transfer)
  • Time to pregnancy(From the day of entering oocyte retrieval cycle to the embryo transfer day of a later assured ongoing pregnancy,which is up to 24 months within the study period.)
  • Pregnancy outcome(up to 42 days of a live birth)

Study Sites (1)

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