Effects of PGS in Infertile Female Patients With RPL

July 9, 2017 updated by: ShangHai Ji Ai Genetics & IVF Institute

Effects of Preimplantation Genetic Screening for Aneuploidies in Infertile Female Patients With Recurrent Spontaneous Abortion History

Recurrent pregnancy loss (RPL) is a multifactorial disorder which affects about 1% of all couples and challenges both patients and clinicians technically and emotionally. IVF clinics see higher prevalence of RPL, since many RPL patients are seeking for assist reproduction treatment with or without other infertile factors. Guidelines for evaluation and treatment of RPL patients include screening for uterine abnormalities, parental chromosomes, autoimmune antibodies and cure gynecological infections, but there are still half of RPL patients remain unexplained.

The documented high incidence of chromosomal errors in first-trimester miscarriages and an increased rate of aneuploidy in patients with RPL has led to the theory that screening embryos before implantation for aneuploidy may decrease the risk of a subsequent loss and serve as a possible treatment. The technology, indications of use, and even terminology for genetic testing of embryos have greatly changed since the first PGD(pre-implantation genetic diagnosis) baby was born in 1990. The current best evidence shows blastocyst biopsy followed by new rapid comprehensive chromosome screening(termed pre-implantation chromosomal screening or comprehensive chromosome screening, PCS or CCS, or the investigators generally termed PGS) based on array-comprehensive genome hybridization(aCGH), single nucleotide polymorphism array(SNP-array) or next generation sequencing(NGS), to be the most powerful technology. However, for whom this PGS technique is most suitable to achieve improved clinical outcome have not yet been identified by well defined, ITT based research with carefully selected control and adequate sample size.

The investigators research is to determine whether in vitro fertilization (IVF)/ intracytoplasmic sperm injection (ICSI) combined with SNP-array based pre-implantation comprehensive chromosome screening (CCS) will improve the clinical outcome of infertile female patients with recurrent spontaneous abortion history.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

189

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 Locations

  • China
      • Shanghai, China, 200011
        • Shanghai JiAi Genetics & IVF Institute

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

18 years to 48 years (ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

Women 18-48 years of age who are scheduled for IVF or ICSI with a history of recurrent spontaneous abortion (continous miscarriage occurred earlier than 20 weeks of gestation for equal or greater than 2 times) in our IVF institute while meeting the following criteria:

  1. regular menstrual cycles and normal level of E2, P, FSH, LH, T, RPL in the early follicular phase;
  2. no history of hormone medicine application in the last 3 months;
  3. no history of poison contact;
  4. normal uterine and adnexal ultrasonography;
  5. TORCH(-), chlamydia(-), mycoplasma(-), normal leucorrhoea routine, anti-phospholipid antibody (-), antinuclear antibody(-);
  6. for the couple, no blood type incompatibility or ABO antibody IgG≤1：64 and normal blood chromosome analysis.

Exclusion Criteria:

  1. hydrosalpinx without operation; endometriosis; polycystic ovary syndrome; adenomyosis; uterine leiomyomata(submucous myoma or non-submucous myoma which size was exceed 4cm and/or with the compressed endometrium);uterine cavity lesions(such as uterine malformation, intrauterine adhesions, the septate uterus, endometritis etc);
  2. the former abortion is because of luteal phase defect without treatment;
  3. thyroid dysfunction or increased CA125 level;
  4. acute inflammation of genitourinary system or STD carriers;
  5. unable to comply with the study procedures.

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
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: With PGS

IVF/ICSI cycles with PGS. Select embryos by SNP-array based PGS for the number of all chromosomes on day 5, only euploid embryos will be transferred.

A maximum of 2 embryos will be transferred for each treatment cycle. Up to 3 treatment cycles will be offered.
Procedure: IVF/ICSI
In vitro fertilization or intracytoplasmic sperm injection.
Genetic: PGS
Selection of embryos are based on SNP-array-based preimplantation genetic screening for the number of all chromosomes on the 5th day of IVF/ICSI.
ACTIVE_COMPARATOR: Without PGS

IVF/ICSI cycles without PGS. Selection of embryos are based on blastocyst morphology criteria on day 5.

A maximum of 2 embryos will be transferred for each treatment cycle. Up to 3 treatment cycles will be offered.
Procedure: IVF/ICSI
In vitro fertilization or intracytoplasmic sperm injection.
Other: Without PGS
Selection of embryos are based on morphology criteria on the 5th day of IVF/ICSI.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Ongoing pregnancy
Time Frame: 12 weeks after embryo transfer for the patient

Ongoing pregnancy is defined as a viable intrauterine pregnancy after 12 weeks of embryo transfer.

Ongoing pregnancy rate per treatment cycle will also be calculated on intend-to-treat(ITT) basis.
12 weeks after embryo transfer for the patient

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Clinical pregnancy
Time Frame: 4 weeks after embryo transfer for the patient

Clinical pregnancy is defined as the presence of a gestational sac confirmed by transvaginal ultrasound examination.

Clinical pregnancy rate per treatment cycle will also be calculated based on ITT.
4 weeks after embryo transfer for the patient
Implantation of transferred embryo
Time Frame: 2 weeks after embryo transfer for the patient
Implantation rate per embryo transferred will also be calculated.
2 weeks after embryo transfer for the patient
Time to pregnancy
Time Frame: from the date of the first time entering oocyte retrieval cycle until the embryo transfer day of a later assured ongoing pregnancy, accessed up to 24 months during the whole research period
Time to pregnancy is defined as from the first time 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 obtain ongoing pregnancy during the study period, the "time to pregnancy" will not be recorded for the specific patient or be calculated for the "average time to pregnancy" for the arm.
from the date of the first time entering oocyte retrieval cycle until the embryo transfer day of a later assured ongoing pregnancy, accessed up to 24 months during the whole research period
Pregnancy outcome
Time Frame: up to 42 days of a live birth
abortion, live birth, multiple births, birth defect, preterm delivery, small-for-gestational age, still birth, maternal complications will be recorded.
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

Investigators

  • Study Director: XIAOXI SUN, MD, Shanghai JiAi Genetics & IVF Institute
  • Principal Investigator: YILUN SUI, MD, Shanghai JiAi Genetics & IVF Institute

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

August 1, 2014

Primary Completion (ACTUAL)

July 31, 2016

Study Completion (ACTUAL)

April 30, 2017

Study Registration Dates

First Submitted

August 18, 2014

First Submitted That Met QC Criteria

August 21, 2014

First Posted (ESTIMATE)

August 22, 2014

Study Record Updates

Last Update Posted (ACTUAL)

July 11, 2017

Last Update Submitted That Met QC Criteria

July 9, 2017

Last Verified

July 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • JIAI E2014-02

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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