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.

Study Timeline

• Study First Submitted: 2022-06-28
• Study First Submitted QC: 2022-06-28
• Study First Posted: 2022-07-01
• Study Start: 2022-09-16
• Status Verified: 2024-01
• Last Update Submitted: 2024-01-15
• Last Update Posted: 2024-01-18
• Primary Completion: 2024-06-01
• Study Completion: 2025-05-31

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

Name	Time	Method
live birth rate of initial embryo transfer	22 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

Name	Time	Method
Maternal complications	48 months	Number of pregnancies with complications / number of pregnancies.
Birth weight	36 months	Weight of newborns at delivery.
Good Birth Outcome rate	36 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 rate	36 months	Number of pregnancy losses / number of clinical pregnancies after transfer.
Clinical pregnancy rate	36 months	Twenty days after conception, transvaginal ultrasonography will be performed. Clinical pregnancy will be diagnosed with detection of an intrauterine gestational sac.
Duration of pregnancy	36 months	Duration of pregnancy is the period between conception and birth.
Neonatal complications	48 months	Number of live births with neonatal complications / number of live births.
Multiple pregnancy rate	36 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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