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Effects of PGS2.0 in Patients With Unexplained RPL

NCT03214185 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 710

Last updated 2018-02-06

No results posted yet for this study

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

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.

Sponsors & Collaborators

  • The International Peace Maternity & Child Health Hospital of China welfare institute

    collaborator UNKNOWN

  • RenJi Hospital

    collaborator OTHER

  • ShangHai Ji Ai Genetics & IVF Institute

    lead OTHER

Principal Investigators

  • XIAOXI SUN, PHD · Shanghai Ji Ai Genetics & IVF Institute, Obstetrics and Gynecology Hospital, Fudan University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
20 Years
Max Age
37 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-02-06
Primary Completion
2020-09-30
Completion
2021-09-30

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03214185 on ClinicalTrials.gov