Effects of PGS2.0 in Patients With Unexplained RPL

Not Applicable

• Conditions: Recurrent Pregnancy Loss; Infertility, Female
• Interventions: Procedure: IVF/ICSI; Genetic: PGS 2.0; Other: Conventional embryo morphology evaluation

• Registration Number: NCT03214185
• Lead Sponsor: ShangHai Ji Ai Genetics & IVF Institute

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2017-07
• Study First Submitted: 2017-07-09
• Study First Submitted QC: 2017-07-09
• Study First Posted: 2017-07-11
• Last Update Submitted: 2018-02-04
• Study Start: 2018-02-06
• Last Update Posted: 2018-02-06
• Primary Completion: 2020-09-30
• Study Completion: 2021-09-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 710

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
With PGS 2.0	PGS 2.0	Patients will undergo IVF/ICSI procedure, and experience oocyte aspiration, fertilization,blastocyst formation,conventional embryo morphology evaluation and trophectoderm biopsy before blastocyst cryopreservation. Preimplantation genetic screening (PGS) will be performed to select euploid embryo. The patients will go through up to three times of frozen-thawed transfers of euploid blastocysts until ongoing pregnancy or live birth is acquired. Only one euploid blastocyst will be transferred at a time.
Without PGS 2.0	IVF/ICSI	Patients will undergo IVF/ICSI procedure, and experience oocyte aspiration, fertilization,blastocyst formation,and conventional embryo morphology evaluation before blastocyst cryopreservation. The patients will go through up to three times of frozen-thawed transfers of good quality blastocysts until ongoing pregnancy or live birth is acquired. Only one good quality blastocyst will be transferred at a time.
With PGS 2.0	IVF/ICSI	Patients will undergo IVF/ICSI procedure, and experience oocyte aspiration, fertilization,blastocyst formation,conventional embryo morphology evaluation and trophectoderm biopsy before blastocyst cryopreservation. Preimplantation genetic screening (PGS) will be performed to select euploid embryo. The patients will go through up to three times of frozen-thawed transfers of euploid blastocysts until ongoing pregnancy or live birth is acquired. Only one euploid blastocyst will be transferred at a time.
Without PGS 2.0	Conventional embryo morphology evaluation	Patients will undergo IVF/ICSI procedure, and experience oocyte aspiration, fertilization,blastocyst formation,and conventional embryo morphology evaluation before blastocyst cryopreservation. The patients will go through up to three times of frozen-thawed transfers of good quality blastocysts until ongoing pregnancy or live birth is acquired. Only one good quality blastocyst will be transferred at a time.

Primary Outcome Measures

Name	Time	Method
Live birth rate per initiated cycle	up to 42 days of a live birth	live birth rate of a baby per oocyte retrieval cycle initiated

Secondary Outcome Measures

Name	Time	Method
Embryo implantation	2 weeks after embryo transfer	positive serum hCG after 2 weeks of embryo transfer
Clinical pregnancy	4 weeks after embryo transfer	the presence of a gestational sac confirmed by transvaginal ultrasound examination
Ongoing pregnancy	10 weeks after embryo transfer	the fetal heat beat continued at 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.	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.If the patient fails to obtain ongoing pregnancy during the study period, this outcome measure will not be recorded.
Pregnancy outcome	up to 42 days of a live birth	abortion, multiple birth, birth defects, preterm delivery, small for gestational age, still birth

Trial Locations

Locations (1)

Shanghai Ji Ai Genetics & IVF Institute, Obstetrics and Gynecology Hospital, Fudan University; 🇨🇳 Shanghai, Shanghai, China