Effects of PGS in Infertile Female Patients With RPL

Summary

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.

Conditions

• Infertility, Female
• Abortion, Habitual

Interventions

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.

OTHER

Without PGS

Selection of embryos are based on morphology criteria on the 5th day of IVF/ICSI.

Sponsors & Collaborators

• ShangHai Ji Ai Genetics & IVF Institute

  lead OTHER

Principal Investigators

• XIAOXI SUN, MD · Shanghai Jiai Genetics & IVF Institute

• YILUN SUI, MD · Shanghai Jiai Genetics & IVF Institute

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

48 Years

Sex

FEMALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2014-08-31

Primary Completion

2016-07-31

Completion

2017-04-30

Countries

• China

Study Locations