ESNi-PGT: Embryo Selection by Noninvasive Preimplantation Genetic Test

Sponsor
Peking University Third Hospital (Other)
Overall Status
Recruiting
CT.gov ID
NCT04339166
Collaborator
Jinling Hospital,Nanjing University,School Medicine (Other), Hebei Maternity and Reproductive hospital (Other), Northwest Women's and Children's Hospital, Xi'an, Shaanxi (Other), The First Medical Center of Chinese People's Liberation Army General Hospital (Other), Shengjing Hospital (Other), First Affiliated Hospital, Sun Yat-Sen University (Other), Reproductive & Genetic Hospital of CITIC-Xiangya (Other), Yikon Genomics Company, Ltd (Other), Peking University Shenzhen Hospital (Other), The Second Hospital of Hebei Medical University (Other), West China Second Hospital of Sichuan University (Other), Second Affiliated Hospital of Wenzhou Medical University (Other), Third Affiliated Hospital of Zhengzhou University (Other)
1,148
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Study Details

Study Description

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
  • Diagnostic Test: Non-invasive chromosome screening(NICS)
N/A

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 Design

Study Type:
Interventional
Anticipated 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 :
Apr 16, 2020
Anticipated Primary Completion Date :
Dec 31, 2022
Anticipated Study Completion Date :
Dec 31, 2023

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

  1. Ongoing pregnancy rate [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 [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 [28 weeks of after the first embryo transfer]

    Number of pregnancy losses / number of clinical pregnancies after the first transfer.

  3. Live birth rate [within 2 weeks after live birth]

    Number of women with live births after the first transfer / number of women randomized to the specific group.

Eligibility Criteria

Criteria

Ages Eligible for Study:
35 Years to 42 Years
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
Yes
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

  1. Untreated hyperprolactinemia, thyroid disease, adrenal disease

  2. Women with endometrial polyps that were not treated before embryo transfer

Contacts and Locations

Locations

Site City State Country Postal Code
1 The First Affiliated Hospital,Sun Yat-sen University Guanzhou Guangdong China
2 Peking University Shenzhen Hospital Shenzhen Guangdong China
3 The Second Hospital of Hebei Medical University Shijia Zhuang Hebei China
4 Hebei Maternity and Reproductive hospital Shijiazhuang Hebei China
5 The Third Affiliated Hospital of Zhengzhou University Zhengzhou Henan China
6 Reproductive & Genetic Hospital of Citic-Xiangya Changsha Hunan China
7 Jinling Hospital,Nanjing University,School Medicine Nanjing Jiangsu China
8 Shengjing Hospital of China Medical University Shenyang Liaoning China
9 West China Second Hospital of Sichuan University Chengdu Sichuan China
10 The Second Affiliated Hospital of Wenzhou Medical University Wenzhou Zhejiang China
11 Peking University Third Hospital Beijing China
12 The First Medical Center of Chinese People's Liberation Army General Hospital Beijing China
13 Northwest women's and children's hospital Xi'an China

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

  • Principal Investigator: Jie Qiao, Peking University Third Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Jie Qiao, Professor, Peking University Third Hospital
ClinicalTrials.gov Identifier:
NCT04339166
Other Study ID Numbers:
  • ESNi-PGT
First Posted:
Apr 9, 2020
Last Update Posted:
Apr 1, 2022
Last Verified:
Mar 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Jie Qiao, Professor, Peking University Third Hospital
Additional relevant MeSH terms:

Study Results

No Results Posted as of Apr 1, 2022