Effects of PGS2.0 in Patients With Unexplained RPL

February 4, 2018 updated by: ShangHai Ji Ai Genetics & IVF Institute

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

710

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • China
    • Shanghai
      • Shanghai, Shanghai, China, 200011
        • Recruiting
        • Shanghai Ji Ai Genetics & IVF Institute, Obstetrics and Gynecology Hospital, Fudan University
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 37 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion criteria:

  1. The couple has experienced two or more failed pregnancies (according to ASRM definition).
  2. The karyotypes of both husband and wife are normal (polymorphic chromosomes are considered normal either).

3. Women ages ≥20 and <38 years old.

Exclusion criteria:

  1. the wife has history of the following diseases: a, the history of thyroid disease; b, the history of adrenal diseases; c, the history of sexually transmitted diseases; d, the history of hereditary diseases; e, the history of mental and psychological disorders.
  2. the wife has the following uterine abnormalities: a, uterine malformations (uterus unicorns and duplex uterus), untreated septate uterus, adenomyoma, submucous uterine fibroids, endometrial polyps, or intrauterine adhesions (including the history of intrauterine adhesions).
  3. the wife has a medical condition that contraindicate ART or pregnancy, including poorly controlled type I or type II diabetes; undiagnosed liver and renal disease or liver and renal insufficiency (based on blood test); deep vein thrombosis; pulmonary embolism; history of cerebrovascular accident; uncontrolled hypertension; cardiac disease; carcinoma; severe anemia; suspicious or undiagnosed vaginal bleeding.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: With 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.
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.
Active Comparator: Without PGS 2.0
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.
Procedure: IVF/ICSI
in vitro fertilization or intracytoplasmatic sperm injection
Other: Conventional embryo morphology evaluation
Blastocysts are selected by morphology criteria and only good-scored embryo will be transferred.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
up to 42 days of a live birth

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Embryo implantation
Time Frame: 2 weeks after embryo transfer
positive serum hCG after 2 weeks of embryo transfer
2 weeks after embryo transfer
Clinical pregnancy
Time Frame: 4 weeks after embryo transfer
the presence of a gestational sac confirmed by transvaginal ultrasound examination
4 weeks after embryo transfer
Ongoing pregnancy
Time Frame: 10 weeks after embryo transfer
the fetal heat beat continued at 10 weeks after embryo transfer
10 weeks after embryo transfer
Time to pregnancy
Time Frame: 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.
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
Time Frame: up to 42 days of a live birth
abortion, multiple birth, birth defects, preterm delivery, small for gestational age, still birth
up to 42 days of a live birth

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

ShangHai Ji Ai Genetics & IVF Institute

Collaborators

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

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

February 6, 2018

Primary Completion (Anticipated)

September 30, 2020

Study Completion (Anticipated)

September 30, 2021

Study Registration Dates

First Submitted

July 9, 2017

First Submitted That Met QC Criteria

July 9, 2017

First Posted (Actual)

July 11, 2017

Study Record Updates

Last Update Posted (Actual)

February 6, 2018

Last Update Submitted That Met QC Criteria

February 4, 2018

Last Verified

July 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • JIAI E2017-15

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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