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

Not Applicable
Recruiting
Conditions
Reproductive Techniques, Assisted
DNA Methylation
Registration Number
NCT05442125
Lead Sponsor
Shandong University
Brief Summary

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

Detailed 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.

Recruitment & Eligibility

Status
RECRUITING
Sex
Female
Target Recruitment
1146
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 score of inner cell mass B or A, trophectoderm C or better, and grade 4 or better on Day 5 of embryo culture.

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 for structural 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 or dysfunction (based on serum liver enzyme testing); renal disease or abnormal serum renal function; significant anemia; history of deep venous thrombosis, pulmonary embolus, or cerebrovascular accident; uncontrolled hypertension, known symptomatic heart disease; history of or suspected cervical carcinoma, endometrial carcinoma, or breast carcinoma; undiagnosed vaginal bleeding.

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Primary Outcome Measures
NameTimeMethod
live birth rate of initial embryo transfer22 months

Live birth rate is defined as delivery of any viable infant at 28 weeks or more of gestation, after initial embryo transfer in women using the embryos selected through PIMS or PGT-A or morphological criteria alone.

Secondary Outcome Measures
NameTimeMethod
Maternal complications48 months

Number of pregnancies with complications / number of pregnancies.

Birth weight36 months

Weight of newborns at delivery.

Good Birth Outcome rate36 months

Defined as a live birth of an infant born at ≥ 37 weeks, with a birth weigh between 2500 and 4000g and without a major congenital anomaly

Pregnancy loss rate36 months

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

Clinical pregnancy rate36 months

Twenty days after conception, transvaginal ultrasonography will be performed. Clinical pregnancy will be diagnosed with detection of an intrauterine gestational sac.

Duration of pregnancy36 months

Duration of pregnancy is the period between conception and birth.

Neonatal complications48 months

Number of live births with neonatal complications / number of live births.

Multiple pregnancy rate36 months

Number of multiple pregnancy/number of clinical pregnancies after transfer.

Trial Locations

Locations (28)

Shandong University

🇨🇳

Jinan, Shandong, China

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

🇨🇳

Changchun, China

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

🇨🇳

Changsha, China

900 th Hospital of Joint Logistics Support Force

🇨🇳

Fuzhou, China

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

🇨🇳

Fuzhou, China

Guangzhou Womenand Children's Medical Center

🇨🇳

Guanzhou, China

The Sixth Affiliated Hospital of Sun Yat-sen University

🇨🇳

Guanzhou, China

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

🇨🇳

Guiyang, China

The first affiliated hospital of Hainan Medical University

🇨🇳

Haikou, China

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

🇨🇳

Hangzhou, China

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Shandong University
🇨🇳Jinan, Shandong, China
Zi-Jiang Chen, Professor
Contact
+0086 531 85651190
chenzijiang@vip.163.com
Yuan Gao, Professor
Principal Investigator

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