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

Primary Purpose

Infertility

Status
Terminated
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
chromosome screening with NGS technology
Sponsored by
Reproductive & Genetic Hospital of CITIC-Xiangya
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional screening trial for Infertility focused on measuring advanced age women, blastocyst culture, PGS, live birth rate

Eligibility Criteria

37 Years - 44 Years (Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Reproductive & Genetic Hospital of CITIC-XIANGYA

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

PGS group

control group

Arm Description

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.

After blastocyst culture, blastocysts will be transferred

Outcomes

Primary Outcome Measures

live birth rate

Secondary Outcome Measures

cancellation rate
Pregnancy Rate
abortion rate

Full Information

First Posted
August 10, 2016
Last Updated
January 10, 2022
Sponsor
Reproductive & Genetic Hospital of CITIC-Xiangya
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1. Study Identification

Unique Protocol Identification Number
NCT02868528
Brief Title
A Study of Preimplantation Genetic Screening With Next Generation Sequencing Technology on Advanced Age Women
Official Title
A Prospective Randomized Controlled Study of Preimplantation Genetic Screening With Next Generation Sequencing Technology on Advanced Age Women
Study Type
Interventional

2. Study Status

Record Verification Date
March 2020
Overall Recruitment Status
Terminated
Study Start Date
September 23, 2016 (Actual)
Primary Completion Date
May 2018 (Actual)
Study Completion Date
August 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Reproductive & Genetic Hospital of CITIC-Xiangya

4. Oversight

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infertility
Keywords
advanced age women, blastocyst culture, PGS, live birth rate

7. Study Design

Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
124 (Actual)

8. Arms, Groups, and Interventions

Arm Title
PGS group
Arm Type
Experimental
Arm Description
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.
Arm Title
control group
Arm Type
No Intervention
Arm Description
After blastocyst culture, blastocysts will be transferred
Intervention Type
Genetic
Intervention Name(s)
chromosome screening with NGS technology
Primary Outcome Measure Information:
Title
live birth rate
Time Frame
At birth
Secondary Outcome Measure Information:
Title
cancellation rate
Time Frame
Up to the day of embryo transferred
Title
Pregnancy Rate
Time Frame
Up to 28th day after embryo transferred
Title
abortion rate
Time Frame
Through pregnancy period,average 10 months

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
37 Years
Maximum Age & Unit of Time
44 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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: . Elder years (≥40 years) or have other known inherited or acquired risk factors that may reduce follicle. .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. .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
Facility Information:
Facility Name
Reproductive & Genetic Hospital of CITIC-XIANGYA
City
Changsha
State/Province
Hunan
ZIP/Postal Code
410000
Country
China

12. IPD Sharing Statement

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

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