ClinicalTrials.gg
TerminatedNCT02868528Updated Jan 26, 2022

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

An interventional study of chromosome screening with NGS technology in Infertility, sponsored by Reproductive & Genetic Hospital of CITIC-Xiangya. Terminated at 1 site in China. Open to female participants aged 37 Years to 44 Years. Per ClinicalTrials.gov, last updated 2022-01-26.

Sponsored by Reproductive & Genetic Hospital of CITIC-Xiangya · Not applicable, Interventional, and Screening

Phase
Not applicable
Study type
Interventional
Enrollment
124
Allocation
Randomized
Ages
37 Years to 44 Years
Sex
Female
01

Study 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.

02

Conditions studied

  • Infertility

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Keywords

  • advanced age women
  • blastocyst culture
  • PGS
  • live birth rate
03

In context

Infertility

2,085 studies on the registry are indexed under Infertility; 357 are open to participants now.

This study's enrollment of 124 is close to the median of 135 across 1,412 interventional studies indexed under Infertility.

Browse Infertility studies →

Lead sponsor

Reproductive & Genetic Hospital of CITIC-Xiangya is the lead sponsor of 26 studies on the registry; 2 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
37 Years to 44 Years
Sexes eligible
Female
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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
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Study design

Phase
Not applicable
Primary purpose
Screening
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
124 participants (actual)

Study arms

  • 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.

    Genetic: chromosome screening with NGS technology

  • No intervention
    control group

    After blastocyst culture, blastocysts will be transferred

Interventions

  • Geneticchromosome screening with NGS technology
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What researchers measure

Primary outcomes

  1. live birth rate

    Time frame: At birth

Secondary outcomes

  1. cancellation rate

    Time frame: Up to the day of embryo transferred

  2. Pregnancy Rate

    Time frame: Up to 28th day after embryo transferred

  3. abortion rate

    Time frame: Through pregnancy period,average 10 months

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Study locations

1 site
  • Reproductive & Genetic Hospital of CITIC-XIANGYA
    Changsha, Hunan 410000, China
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 26, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02868528
Lead sponsor
Reproductive & Genetic Hospital of CITIC-Xiangya
Responsible party
Sponsor
First posted
Aug 16, 2016
Start date
Sep 23, 2016
Primary completion
May 2018
Completion
Aug 2019
Last update
Jan 26, 2022
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is terminated, as verified in Mar 2020. You cannot join it, but the record below documents what was studied.

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