A Study of Preimplantation Genetic Screening With Next Generation Sequencing Technology on Advanced Age Women

A Prospective Randomized Controlled Study of Preimplantation Genetic Screening With Next Generation Sequencing Technology on Advanced Age Women

With the development of society, more and more aged pregnant women because of various reasons, their abnormality rate of egg chromosome was higher than that of young women, then the abnormality rate of embryo chromosome is higher too, so the pregnancy rate in aged women is lower, abortion rate is higher. In order to improve the pregnancy rate in aged women, cut down their abortion rate 、fetal birth with abnormal chromosome, and the risk of pregnancy termination after the prenatal diagnosis, reduce their pain of body and mind, the investigators will carry out this study. This is a prospective randomized controlled study of preimplantation genetic screening with Next generation sequencing technology. The embryos with more developmental potential and normal chromosomes should be selected. There is no related studies in Chinese. Most international research are limited to fluorescence in situ hybridization (FISH) technique, not on the embryo chromosome comprehensive screening. So there is no evidence of the effects of PGS on advanced age women.

This study is to compare the outcomes between the advanced age women with two methods respectively. After blastocyst culture, blastocysts will be transferred in the control group. In the Preimplantation Genetic Screening (PGS) group, blastocyst embryo trophoblast biopsy will be performed and chromosome screening with Next generation sequencing(NGS) technology, at the same time, the blastocysts will be frozen, then the blastocysts with normal chromosome will be thawed and transferred. The investigators expect that, in PGS group live birth rate 、cancellation rate and pregnancy rate are higher than in control group; abortion rate is lower than that of the control group.

Study Overview

Status

Terminated

Conditions

Study Type

Interventional

Enrollment (Actual)

124

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

    • Hunan
      • Changsha, Hunan, China, 410000
        • Reproductive & Genetic Hospital of CITIC-Xiangya

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

37 years to 44 years (ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Premenopausal females, age ≥37 years ≤44 years
  • Have given birth to a healthy baby
  • Bilateral ovaries
  • Antral follicle count(AFC)≥10,and Anti Mullerian Hormone (AMH)≥2.0 ng/ml

Exclusion Criteria:

  • Endometriosis disease
  • Intrauterine adhesions history; intrauterine membrane polyp, tuberculosis and inflammation,
  • Uterine malformation, multiple uterine myoma, uterine intramural myoma >3cm, submucous myoma;
  • Unprocessed hydrosalpinx
  • Adverse reproductive history; greater than or equal to 2 times history of unexplained abortion
  • Chromosomal abnormalities or other genetic disease
  • Infertility caused by male factors, such as puncture testicular, SRT did not see the class A and class B sperm
  • Without high quality embryos in past controlled ovarian hyperstimulation (COH)cycles.
  • Patients with poor ovarian response, the standard of poor ovarian response accords with Bolognacriteria standard, that is at least meet 2 among the following 3:

    1. . Elder years (≥40 years) or have other known inherited or acquired risk factors that may reduce follicle.
    2. .History of cancellation of the cycles because of less than 3 follicular development, or history of egg number less than 4 after at least using Follicle-Stimulating Hormone(FSH) 150IU once a day.
    3. .Ovarian reserve function test abnormalities, including sinus follicle number less than 5-7 AFC or AMH less than 0.5 to 1.1 ng/ml

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: SCREENING
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: PGS group
After blastocyst culture, blastocyst embryo trophoblast biopsy will be performed and chromosome screening with NGS technology, at the same time, the blastocysts will be frozen, then the blastocysts with normal chromosome will be thawed and transferred.
NO_INTERVENTION: control group
After blastocyst culture, blastocysts will be transferred

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
live birth rate
Time Frame: At birth
At birth

Secondary Outcome Measures

Outcome Measure
Time Frame
cancellation rate
Time Frame: Up to the day of embryo transferred
Up to the day of embryo transferred
Pregnancy Rate
Time Frame: Up to 28th day after embryo transferred
Up to 28th day after embryo transferred
abortion rate
Time Frame: Through pregnancy period,average 10 months
Through pregnancy period,average 10 months

Collaborators and Investigators

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

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 (ACTUAL)

September 23, 2016

Primary Completion (ACTUAL)

May 1, 2018

Study Completion (ACTUAL)

August 1, 2019

Study Registration Dates

First Submitted

August 10, 2016

First Submitted That Met QC Criteria

August 14, 2016

First Posted (ESTIMATE)

August 16, 2016

Study Record Updates

Last Update Posted (ACTUAL)

January 26, 2022

Last Update Submitted That Met QC Criteria

January 10, 2022

Last Verified

March 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KYXM-201603

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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