Embryo Selection by Noninvasive Preimplantation Genetic Test
NCT ID: NCT04339166
Last Updated: 2024-12-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
1152 participants
INTERVENTIONAL
2020-04-16
2024-08-06
Brief Summary
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Detailed Description
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In recent years, researchers have found that the spent medium of embryo culture contains trace amount of cell-free DNA, which may reflect the ploidy of the embryo. The non-invasive chromosome screening (NICS) approach utilizing spent culture medium samples has been evaluated in studies. However, the clinical value of NICS as a new effective indicator to evaluate embryo competence so far has not been justified by randomized clinical trials.
The main purpose of this project is to verify whether NICS can be used as a new effective indicator for evaluating embryo developmental potential through multi-center, randomized clinical trials
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
SCREENING
DOUBLE
Study Groups
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Group A
Single thawed blastocyst transfer with blastocyst selection according to the analysis of NICS and morphologic score.
Non-invasive chromosome screening（NICS）
NICS is noninvasive chromosome screening approach to analysis the euploidy by free DNA in embryo culture medium
Group B
Single thawed blastocyst transfer with blastocyst selection according to morphologic score.
No interventions assigned to this group
Interventions
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Non-invasive chromosome screening（NICS）
NICS is noninvasive chromosome screening approach to analysis the euploidy by free DNA in embryo culture medium
Eligibility Criteria
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Inclusion Criteria
2. Female age: 35 - 42 years old
3. Women receiving controlled ovarian hyperstimulation treatment (including ultra-long protocol、long-protocol 、short protocol treatment with GnRH agonist and GnRH antagonist treatment protocol); and the number of oocytes ≥6; The female BMI is from 18 to 30kg/m2.
4. Culture embryos to blastocyst stage and all the blastocysts will be single cryopreserved.
5. Single frozen-thawed blastocyst Transferred for the first time
6. The number of blastocysts ≥2, morphology grade (above 4BC/4CB)
7. Written informed consent
Exclusion Criteria
2. PGT cycles
3. Women who have pathologies or malformations that affect the pregnancy outcome: genital malformations, untreated hydrosalpinx, untreated uterine infections, intramural myomas \> 4cm , benign tumor of pelvic and abdominal cavity\> 4cm, intimal thickness\<8mm, pituitary tumors and malignant tumors of various tissues and organs during the patient's participation in the study
4. Untreated hyperprolactinemia, thyroid disease, adrenal disease
5. Women with endometrial polyps that were not treated before embryo transfer
35 Years
42 Years
FEMALE
Yes
Sponsors
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Jinling Hospital, China
OTHER
Reproductive Medical Center of Hebei Maternity Hospital
UNKNOWN
Northwest Women's and Children's Hospital, Xi'an, Shaanxi
OTHER
The First Medical Center of Chinese People's Liberation Army General Hospital
UNKNOWN
Shengjing Hospital
OTHER
First Affiliated Hospital, Sun Yat-Sen University
OTHER
Reproductive & Genetic Hospital of CITIC-Xiangya
OTHER
Yikon Genomics Company, Ltd
UNKNOWN
Peking University Shenzhen Hospital
OTHER
The Second Hospital of Hebei Medical University
OTHER
West China Second University Hospital
OTHER
Second Affiliated Hospital of Wenzhou Medical University
OTHER
Third Affiliated Hospital of Zhengzhou University
OTHER
Peking University Third Hospital
OTHER
Responsible Party
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Jie Qiao
Professor
Principal Investigators
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Jie Qiao
Role: PRINCIPAL_INVESTIGATOR
Peking University Third Hospital
Locations
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The First Affiliated Hospital,Sun Yat-sen University
Guanzhou, Guangdong, China
Peking University Shenzhen Hospital
Shenzhen, Guangdong, China
Hebei Maternity and Reproductive hospital
Shijiazhuang, Hebei, China
The Second Hospital of Hebei Medical University
Shijiazhuang, Hebei, China
The Third Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, China
Reproductive & Genetic Hospital of Citic-Xiangya
Changsha, Hunan, China
Jinling Hospital,Nanjing University,School Medicine
Nanjing, Jiangsu, China
Shengjing Hospital of China Medical University
Shenyang, Liaoning, China
West China Second Hospital of Sichuan University
Chengdu, Sichuan, China
The Second Affiliated Hospital of Wenzhou Medical University
Wenzhou, Zhejiang, China
Peking University Third Hospital
Beijing, , China
The First Medical Center of Chinese People's Liberation Army General Hospital
Beijing, , China
Northwest women's and children's hospital
Xi'an, , China
Countries
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References
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Huang J, Rong L, Zeng L, Hu L, Shi J, Cai L, Yao B, Wang XX, Xu Y, Yao Y, Wang Y, Zhao J, Guan Y, Qian W, Hao G, Lu S, Liu P, Qiao J. Embryo selection through non-invasive preimplantation genetic testing with cell-free DNA in spent culture media: a protocol for a multicentre, double-blind, randomised controlled trial. BMJ Open. 2022 Jul 27;12(7):e057254. doi: 10.1136/bmjopen-2021-057254.
Other Identifiers
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ESNi-PGT
Identifier Type: -
Identifier Source: org_study_id