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

April 1, 2024 updated by: Jie Qiao, Peking University Third Hospital

A Multicenter Clinical Study on Embryo Selection by Using the Ploidy of Cell Free DNA in Embryo Culture Medium

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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

Study Type

Interventional

Enrollment (Estimated)

1148

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
      • Beijing, China
        • Recruiting
        • Peking University Third Hospital
        • Contact:
        • Principal Investigator:
          • Jie Qiao
      • Beijing, China
        • Recruiting
        • The First Medical Center of Chinese People's Liberation Army General Hospital
        • Contact:
      • Xi'an, China
        • Recruiting
        • Northwest Women's and Children's Hospital
        • Contact:
    • Guangdong
      • Guanzhou, Guangdong, China
        • Recruiting
        • The First Affiliated Hospital,Sun Yat-sen University
        • Contact:
      • Shenzhen, Guangdong, China
        • Recruiting
        • Peking University Shenzhen Hospital
        • Contact:
          • Weiping Qian, professor
    • Hebei
      • Shijia Zhuang, Hebei, China
        • Recruiting
        • The Second Hospital of Hebei Medical University
        • Contact:
      • Shijiazhuang, Hebei, China
        • Recruiting
        • Hebei Maternity and Reproductive hospital
        • Contact:
    • Henan
      • Zhengzhou, Henan, China
        • Recruiting
        • The Third Affiliated Hospital of Zhengzhou University
        • Contact:
    • Hunan
      • Changsha, Hunan, China
        • Recruiting
        • Reproductive & Genetic Hospital of Citic-Xiangya
        • Contact:
    • Jiangsu
      • Nanjing, Jiangsu, China
        • Recruiting
        • Jinling Hospital,Nanjing University,School Medicine
        • Contact:
    • Liaoning
      • Shenyang, Liaoning, China
        • Recruiting
        • Shengjing Hospital of China Medical University
        • Contact:
    • Sichuan
      • Chengdu, Sichuan, China
        • Recruiting
        • West China Second Hospital of Sichuan University
        • Contact:
    • Zhejiang
      • Wenzhou, Zhejiang, China
        • Recruiting
        • The Second Affiliated Hospital of Wenzhou Medical University
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

33 years to 40 years (Adult)

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Screening
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
12 weeks after the first embryo transfer

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
7 weeks after the first embryo transfer
Miscarriage rate
Time Frame: 28 weeks of after the first embryo transfer
Number of pregnancy losses / number of clinical pregnancies after the first transfer.
28 weeks of after the first embryo 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.
within 2 weeks after live birth

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Peking University Third Hospital

Collaborators

The Second Hospital of Hebei Medical University
First Affiliated Hospital, Sun Yat-Sen University
Shengjing Hospital
Second Affiliated Hospital of Wenzhou Medical University
Peking University Shenzhen Hospital
Reproductive & Genetic Hospital of CITIC-Xiangya
West China Second University Hospital
Third Affiliated Hospital of Zhengzhou University
Jinling Hospital,Nanjing University,School Medicine
Northwest Women's and Children's Hospital, Xi'an, Shaanxi
The First Medical Center of Chinese People's Liberation Army General Hospital
Yikon Genomics Company, Ltd
Reproductive Medical Center of Hebei Maternity Hospital

Investigators

  • Principal Investigator: Jie Qiao, Peking University Third Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 16, 2020

Primary Completion (Actual)

February 28, 2024

Study Completion (Estimated)

August 31, 2024

Study Registration Dates

First Submitted

April 1, 2020

First Submitted That Met QC Criteria

April 7, 2020

First Posted (Actual)

April 9, 2020

Study Record Updates

Last Update Posted (Actual)

April 3, 2024

Last Update Submitted That Met QC Criteria

April 1, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ESNi-PGT

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Data may be shared with proper internal and ethical approval. De-identified data may also be shared with approved study investigators.

IPD Sharing Time Frame

After the study has been completed

IPD Sharing Access Criteria

Proper internal and ethical approval; protect patient confidentiality; approve by study investigators

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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