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Embryo Selection by Noninvasive Preimplantation Genetic Test (ESNi-PGT)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04339166
Recruitment Status : Recruiting
First Posted : April 9, 2020
Last Update Posted : November 2, 2022
Sponsor:
Collaborators:
Jinling Hospital,Nanjing University,School Medicine
Hebei Maternity and Reproductive hospital
Northwest Women's and Children's Hospital, Xi'an, Shaanxi
The First Medical Center of Chinese People's Liberation Army General Hospital
Shengjing Hospital
First Affiliated Hospital, Sun Yat-Sen University
Reproductive & Genetic Hospital of CITIC-Xiangya
Yikon Genomics Company, Ltd
Peking University Shenzhen Hospital
The Second Hospital of Hebei Medical University
West China Second Hospital of Sichuan University
Second Affiliated Hospital of Wenzhou Medical University
Third Affiliated Hospital of Zhengzhou University
Information provided by (Responsible Party):
Jie Qiao, Peking University Third Hospital

Brief Summary:
The objective of this study is to explore whether non-invasive chromosome screening (NICS) can be used as an effective indicator for embryos selection besides morphology through a multicenter randomized controlled trial, by comparing the differences of live birth rate, pregnancy rate and miscarriage rate between the two groups of embryo selection by "NICS+ morphology" and embryo selection only by "morphology" in IVF cycle.

Condition or disease Intervention/treatment Phase
Infertility Chromosome Abnormality Diagnostic Test: Non-invasive chromosome screening(NICS) Not Applicable

Detailed Description:

Chromosomal abnormalities commonly exist in early human embryos, and often cause embryo implantation failure and pregnancy loss in in-vitro fertilization (IVF) treatments. Preimplantation genetic testing for aneuploidies (PGT-A) by comprehensive chromosome screening (CCS) has been widely applied in IVF practices to select embryos with normal ploidy. Although multiple clinical trials have demonstrated improved clinical outcomes with PGT-A, it's in controversial for whether PGT-A is truly worthwhile to be offered to all IVF patients. One of the main concerns is that it involves an embryo biopsy procedure, which is invasive and the long-term safety issue of the embryo biopsy remains to be fully investigated.

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1148 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Screening
Official Title: A Multicenter Clinical Study on Embryo Selection by Using the Ploidy of Cell Free DNA in Embryo Culture Medium
Actual Study Start Date : April 16, 2020
Estimated Primary Completion Date : December 31, 2022
Estimated Study Completion Date : December 31, 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Pregnancy

Arm Intervention/treatment
Experimental: Group A
Single thawed blastocyst transfer with blastocyst selection according to the analysis of NICS and morphologic score.
Diagnostic Test: Non-invasive chromosome screening(NICS)
NICS is noninvasive chromosome screening approach to analysis the euploidy by free DNA in embryo culture medium

No Intervention: Group B
Single thawed blastocyst transfer with blastocyst selection according to morphologic score.



Primary Outcome Measures :
  1. Ongoing pregnancy rate [ Time Frame: 12 weeks after the first embryo transfer ]
    Number of women with ongoing pregnancies after the first transfer/ number of women randomized to the specific group


Secondary Outcome Measures :
  1. Clinical pregnancy rate [ Time Frame: 7 weeks after the first embryo transfer ]
    Number of women with clinical pregnancies after the first transfer / number of women randomized to the specific group

  2. Miscarriage rate [ Time Frame: 28 weeks of after the first embryo transfer ]
    Number of pregnancy losses / number of clinical pregnancies after the first transfer.

  3. Live birth rate [ Time Frame: within 2 weeks after live birth ]
    Number of women with live births after the first transfer / number of women randomized to the specific group.



Information from the National Library of Medicine

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Ages Eligible for Study:   35 Years to 42 Years   (Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   IVF patients
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Infertile couples receiving IVF- ICSI procedure for assisted reproduction cycle
  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:

  1. One of couples with IVF or ICSI contraindications(such as poorly controlled type I or type II diabetes; liver disease or dysfunction; kidney disease or renal function abnormality; significant anemia; history of deep venous thrombosis, pulmonary embolus; history of cerebrovascular accident; uncontrolled hypertension or diagnosed heart disease; history of cervical, endometrial or breast cancer; undiagnosed vaginal bleeding.)
  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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04339166


Contacts
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Contact: Jie Qiao 010-82265080 jie.qiao@263.net

Locations
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China, Guangdong
The First Affiliated Hospital,Sun Yat-sen University Recruiting
Guanzhou, Guangdong, China
Contact: yanwen xu, professor    020-87606345    xuyanwen@live.cn   
Peking University Shenzhen Hospital Recruiting
Shenzhen, Guangdong, China
Contact: Weiping Qian, professor         
China, Hebei
The Second Hospital of Hebei Medical University Recruiting
Shijia Zhuang, Hebei, China
Contact: Guimin Hao, professor    0311-66002721    haoguimin@163.com   
Hebei Maternity and Reproductive hospital Recruiting
Shijiazhuang, Hebei, China
Contact: Liyi Cai    0311-82626066    cai760829@163.com   
China, Henan
The Third Affiliated Hospital of Zhengzhou University Recruiting
Zhengzhou, Henan, China
Contact: Yichun Guan, professor    0371-66903686    lisamayguan@126.com   
China, Hunan
Reproductive & Genetic Hospital of Citic-Xiangya Recruiting
Changsha, Hunan, China
Contact: Liang Hu    0731-82355100-8973    lianghu7@gmail.com   
China, Jiangsu
Jinling Hospital,Nanjing University,School Medicine Recruiting
Nanjing, Jiangsu, China
Contact: Bing Yao    025-80860174    yaobing@nju.edu.cn   
China, Liaoning
Shengjing Hospital of China Medical University Recruiting
Shenyang, Liaoning, China
Contact: Xiuxia Wang    024-9661540131    wangxxsj@sina.cn   
China, Sichuan
West China Second Hospital of Sichuan University Recruiting
Chengdu, Sichuan, China
Contact: Yan Wang, professor    028-88570494    wangyy1210@163.com   
China, Zhejiang
The Second Affiliated Hospital of Wenzhou Medical University Recruiting
Wenzhou, Zhejiang, China
Contact: Junzhao Zhao, professor    0577-88002304    z.joyce08@163.com   
China
Peking University Third Hospital Recruiting
Beijing, China
Contact: Jie Qiao    010-82265080    jie.qiao@263.net   
Principal Investigator: Jie Qiao         
The First Medical Center of Chinese People's Liberation Army General Hospital Recruiting
Beijing, China
Contact: Yuanqing Yao    010-66939258    yqyao@126.com   
Northwest women's and children's hospital Recruiting
Xi'an, China
Contact: Juanzi Shi    029-87219120    shijuanzi123@126.com   
Sponsors and Collaborators
Peking University Third Hospital
Jinling Hospital,Nanjing University,School Medicine
Hebei Maternity and Reproductive hospital
Northwest Women's and Children's Hospital, Xi'an, Shaanxi
The First Medical Center of Chinese People's Liberation Army General Hospital
Shengjing Hospital
First Affiliated Hospital, Sun Yat-Sen University
Reproductive & Genetic Hospital of CITIC-Xiangya
Yikon Genomics Company, Ltd
Peking University Shenzhen Hospital
The Second Hospital of Hebei Medical University
West China Second Hospital of Sichuan University
Second Affiliated Hospital of Wenzhou Medical University
Third Affiliated Hospital of Zhengzhou University
Investigators
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Principal Investigator: Jie Qiao Peking University Third Hospital
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Jie Qiao, Professor, Peking University Third Hospital
ClinicalTrials.gov Identifier: NCT04339166    
Other Study ID Numbers: ESNi-PGT
First Posted: April 9, 2020    Key Record Dates
Last Update Posted: November 2, 2022
Last Verified: October 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Data may be shared with proper internal and ethical approval. De-identified data may also be shared with approved study investigators.
Supporting Materials: Study Protocol
Time Frame: After the study has been completed
Access Criteria: Proper internal and ethical approval; protect patient confidentiality; approve by study investigators

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Jie Qiao, Peking University Third Hospital:
Culture media
Embryonic cell-free DNA
Euploidy
Additional relevant MeSH terms:
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Infertility
Chromosome Disorders
Chromosome Aberrations
Congenital Abnormalities
Pathologic Processes
Genetic Diseases, Inborn