- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02868528
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
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Hunan
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Changsha, Hunan, China, 410000
- Reproductive & Genetic Hospital of CITIC-Xiangya
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
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:
- . 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
Study Plan
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.
|
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NO_INTERVENTION: control group
After blastocyst culture, blastocysts will be transferred
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
live birth rate
Time Frame: At birth
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At birth
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
cancellation rate
Time Frame: Up to the day of embryo transferred
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Up to the day of embryo transferred
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Pregnancy Rate
Time Frame: Up to 28th day after embryo transferred
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Up to 28th day after embryo transferred
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abortion rate
Time Frame: Through pregnancy period,average 10 months
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Through pregnancy period,average 10 months
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Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
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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