Retrospective Study on Clinical Results of Preimplantation Genetic Screening at Different Embryo Stage

Institute of Medicine, Chung Shan Medical University

Preimplantational genetic screen (PGS) is tool for diagnosis of embryo chromosome abnormality before transfer. Under this tool, patients with a family history of genetic disease or special genetic disease could avoid to produce chromosomal abnormalities of the next pregnant. This study is a retrospective study, data collection from 2001 Jan. to 2015. Nov. Patients underwent PGS and data including the couples age, infertility factors, stimulation protocols, medicine records, embryo quality records and blood tests were collected in this study. Analysis the relationship between outcomes of PGS, clinical outcomes and embryo quality is performed and further to find a diagnosis reference for clinical care.

Study Overview

• Status: Completed
• Conditions: Fertility Disorders; Genetic Disorder; Reproductive Disorder
• Intervention / Treatment: Other: PGS

Detailed Description

Research background Preimplantational genetic screen (PGS) is tool for diagnosis of embryo chromosome abnormality before transfer. Under this tool, patients with a family history of genetic disease or special genetic disease could avoid to produce chromosomal abnormalities of the next pregnant. For the preemergence of embryos before the genetic diagnosis must be carried out artificial reproductive treatment, the process includes induction of ovulation, ovulation, in vitro fertilization and embryo culture, to embryos grow to six to eight cells or cultured into the stage of blastocyst stage, Under the embryonic section, take one or several cells, the slices of cells for genetic diagnosis, select the embryo without genetic disease implanted in the uterine cavity, in order to avoid the birth of genetic disease offspring.

PGS can reduce the pregnancy when the chromosomal abnormalities of the fetus after implantation, but also to reduce the risk of abortion from chromosomal abnormalities, and can avoid the couples implanted with genetic abnormalities of the embryos, thereby significantly reducing it is important to promote the process of eugenics and reduce the social cost.

Research purposes The detection of chromosomal abnormalities of embryos are important factors for clinical diagnosis or screening before implantation. However, there is no complete analysis of domestic studies. This program will compare the genes or chromosomal abnormalities and clinical outcomes of embryo testing at different stages of embryonic development.

Research design This study is a retrospective study, data collection from 2001 Jan. to 2015. Nov. Patients underwent PGS and data including the couples age, infertility factors, stimulation protocols, medicine records, embryo quality records and blood tests were collected in this study. Analysis the relationship between outcomes of PGS, clinical outcomes and embryo quality is performed and further to find a diagnosis reference for clinical care.

• Study Type: Observational
• Enrollment (Actual): 500

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 50 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

• Sampling Method: Non-Probability Sample

Study Population

Women underwent in vitro fertilization (IVF) treatment and preimplantational genetic screen (PGS).

Description

Inclusion Criteria:

• Women underwent in vitro fertilization (IVF) treatment and preimplantational genetic screen (PGS).

Exclusion Criteria:

• N/A

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
PGSno.; blastocysts from patients underwent preimplantational genetic screen (PGS) prtocols. only euploid embryos were selected to transfer.	Other: PGS; chromosome abnormality test from PGS and relationship between embryo development

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
implantation rate	detection sac after embryo transfer	1~2 week after pregnancy test

Collaborators and Investigators

• Sponsor: Yeh
• Investigators: Study Chair: Maw-Sheng Lee, Phd, Lee's Women Hospital

Publications and helpful links

General Publications

• Chen HH, Huang CC, Cheng EH, Lee TH, Chien LF, Lee MS. Optimal timing of blastocyst vitrification after trophectoderm biopsy for preimplantation genetic screening. PLoS One. 2017 Oct 5;12(10):e0185747. doi: 10.1371/journal.pone.0185747. eCollection 2017.

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2014
• Primary Completion (Actual): November 30, 2015
• Study Completion (Actual): November 30, 2015

Study Registration Dates

• First Submitted: February 22, 2017
• First Submitted That Met QC Criteria: February 22, 2017
• First Posted (Actual): February 27, 2017

Study Record Updates

• Last Update Posted (Actual): February 27, 2017
• Last Update Submitted That Met QC Criteria: February 22, 2017
• Last Verified: February 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Disease; Genetic Diseases, Inborn
• Other Study ID Numbers: CS14124

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