First Live Birth Rate With eSET After Preimplantation Methylome Screening (PIMS) Versus Conventional In-vitro Fertilization

Last updated: January 15, 2024
Sponsor: Shandong University
Overall Status: Active - Recruiting

Phase

N/A

Condition

N/A

Treatment

Using DNA methylome to select embryos

Using morphologic score to select embryos

Clinical Study ID

NCT05442125
PIMS-IVF
  • Ages > 20
  • Female
  • Accepts Healthy Volunteers

Study Summary

To determine whether using DNA methylome to select embryos can increase the live birth rate.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Women who plan to undergo IVF/ICSI/PGT-A treatment.
  2. Women aged 20 years and older. b) Women who obtain 2 or more good-quality blastocysts that defined as morphological scoreof inner cell mass B or A, trophectoderm C or better, and grade 4 or better on Day 5 ofembryo culture.

Exclusion

Exclusion Criteria:

4.2 Exclusion Criteria

  1. Women with a uterine cavity abnormality, such as a uterine congenital malformation (uterus unicornate, bicornate, or duplex); untreated uterine septum, submucous myoma,or endometrial polyp(s); or with history of intrauterine adhesions.
  2. Women who are indicated and planned to undergo preimplantation genetic testing forstructural rearrangements (PGT-SR) or preimplantation genetic testing for monogenic (PGT-M).
  3. Women who use donated oocytes or sperm to achieve pregnancy;
  4. Women with contraindication for assisted reproductive technology or for pregnancy,such as poorly controlled Type I or Type II diabetes; undiagnosed liver disease ordysfunction (based on serum liver enzyme testing); renal disease or abnormal serumrenal function; significant anemia; history of deep venous thrombosis, pulmonaryembolus, or cerebrovascular accident; uncontrolled hypertension, known symptomaticheart disease; history of or suspected cervical carcinoma, endometrial carcinoma, orbreast carcinoma; undiagnosed vaginal bleeding.

Study Design

Total Participants: 1146
Treatment Group(s): 2
Primary Treatment: Using DNA methylome to select embryos
Phase:
Study Start date:
September 16, 2022
Estimated Completion Date:
May 31, 2025

Study Description

The rationale for the study is to establish the risk/benefit ratio of PIMS in women with in vitro fertilization (IVF) treatment, as DNA methylome is a potential biomarker in blastocyst selection in assited reproductive technology (ART). DNA methylation plays an important role during embryogenesis, global abnormal methylome reprogramming often occurs in human embryos, and DNA methylome pattern is associated with live birth rate. However, there is still no technology using DNA methylome as an indicator in preimplantation embryo screening. Recent paper reported that using Pre-implantation Methylome Screening (PIMS) can select embryos with better methylation state and euploid chromosomes. The efficiency of PIMS needs further validation through randomized clinical trial.

Connect with a study center

  • Shandong University

    Jinan, Shandong
    China

    Active - Recruiting

  • Center for Reproductive Medicine, Center for Prenatal Diagnosis First Hospital, Jilin University

    Changchun,
    China

    Active - Recruiting

  • Clinical Research Center for Reproduction and Genetics in Hunan Province, Reproductive and Genetic Hospital of CITIC-XIANGYA

    Changsha, 410008
    China

    Active - Recruiting

  • 900 th Hospital of Joint Logistics Support Force

    Fuzhou,
    China

    Active - Recruiting

  • Fujian Maternity and Child Health Hospital College of Clinical Medicine for Obstetrics & Gynecology and Pediatrics, Fujian Medical University

    Fuzhou,
    China

    Active - Recruiting

  • Guangzhou Womenand Children's Medical Center

    Guanzhou,
    China

    Active - Recruiting

  • The Sixth Affiliated Hospital of Sun Yat-sen University

    Guanzhou,
    China

    Site Not Available

  • Center for Reproductive Medicine, The Affiliated Hospital of Guizhou Medical University

    Guiyang,
    China

    Active - Recruiting

  • The first affiliated hospital of Hainan Medical University

    Haikou,
    China

    Active - Recruiting

  • Assisted Reproduction Unit, Sir Run Run Shaw Hospital, Zhejiang University School of Medicine

    Hangzhou,
    China

    Active - Recruiting

  • The First Affiliated Hospital of Anhui Medical University

    Hefei,
    China

    Active - Recruiting

  • Center for Reproductive Medicine, Shandong University

    Jinan, 250012
    China

    Active - Recruiting

  • Affiliated Hospital of Jining Medical University

    Jining,
    China

    Active - Recruiting

  • Liuzhou Hospital of Guangzhou Women and Children's Medical Center

    Liuzhou,
    China

    Active - Recruiting

  • Department of Reproductive Medicine, Women's Hospital of Nanjing Medical University, Nanjing Maternity and Child Health Care Hospital

    Nanjing,
    China

    Active - Recruiting

  • The First Affiliated Hospital with Nanjing Medical University

    Nanjing,
    China

    Active - Recruiting

  • Center for Reproductive Medicine, Ren Ji Hospital, School of Medicine,Shanghai Jiao Tong University

    Shanghai, 200135
    China

    Active - Recruiting

  • Changhai Hospital

    Shanghai,
    China

    Site Not Available

  • International Peace Maternity and Child Health Hospital, School of Medicine, Shanghai Jiao Tong University

    Shanghai,
    China

    Site Not Available

  • Reproductive Medical Center of Ruijin Hospital, School of Medicine,Shanghai Jiao Tong University

    Shanghai,
    China

    Site Not Available

  • Shanghai Ji Ai Genetics and IVF Institute, Obstetrics and Gynecology Hospital, Fudan University

    Shanghai,
    China

    Site Not Available

  • Shenzhen Maternity & Child Healthcare Hospital

    Shenzhen,
    China

    Active - Recruiting

  • The Second Hospital of Hebei Medical University

    Shijiazhuang,
    China

    Active - Recruiting

  • Center for reproduction and genetics,suzhou municipal hospital

    Suzhou,
    China

    Active - Recruiting

  • The General Hospital of Ningxia Medical University

    Yinchuan,
    China

    Active - Recruiting

  • Department of Reproductive Medicine, the Third Affiliated Hospital of Zhengzhou University

    Zhengzhou,
    China

    Active - Recruiting

  • Reproductive Medical Center, Henan Provincial People's Hospital

    Zhengzhou,
    China

    Active - Recruiting

  • Siriraj hospital, Mahidol university

    Bangkok,
    Thailand

    Site Not Available

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