Embryo Selection by Noninvasive Preimplantation Genetic Test (ESNi-PGT)
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ClinicalTrials.gov Identifier: NCT04339166 |
Recruitment Status :
Recruiting
First Posted : April 9, 2020
Last Update Posted : April 3, 2024
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Condition or disease | Intervention/treatment | Phase |
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Infertility Chromosome Abnormality | Diagnostic Test: Non-invasive chromosome screening(NICS) | Not Applicable |
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
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 |
Actual Primary Completion Date : | February 28, 2024 |
Estimated Study Completion Date : | August 31, 2024 |
Arm | Intervention/treatment |
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Experimental: Group A
Single thawed blastocyst transfer with blastocyst selection according to the analysis of NICS and morphologic score.
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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.
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- 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
- 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
- Miscarriage rate [ Time Frame: 28 weeks of after the first embryo transfer ]Number of pregnancy losses / number of clinical pregnancies after the first transfer.
- 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.
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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 |
Inclusion Criteria:
- Infertile couples receiving IVF- ICSI procedure for assisted reproduction cycle
- Female age: 35 - 42 years old
- 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.
- Culture embryos to blastocyst stage and all the blastocysts will be single cryopreserved.
- Single frozen-thawed blastocyst Transferred for the first time
- The number of blastocysts ≥2, morphology grade (above 4BC/4CB)
- Written informed consent
Exclusion Criteria:
- 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.)
- PGT cycles
- 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
- Untreated hyperprolactinemia, thyroid disease, adrenal disease
- Women with endometrial polyps that were not treated before embryo transfer
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
Contact: Jie Qiao | 010-82265080 | jie.qiao@263.net |
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 |
Principal Investigator: | Jie Qiao | Peking University Third Hospital |
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: | April 3, 2024 |
Last Verified: | April 2024 |
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 |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Culture media Embryonic cell-free DNA Euploidy |
Infertility Chromosome Disorders Chromosome Aberrations Genital Diseases |
Urogenital Diseases Congenital Abnormalities Pathologic Processes Genetic Diseases, Inborn |