PIMS vs PGT-A in Infertile PCOS Patients

ConditionsPGT-APCOSPIMS
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age20-40
SponsorFirst Affiliated Hospital, Sun Yat-Sen University

About this trial

This experiment has become a serious issue for two reasons: 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. The endocrine metabolic disorders of polycystic ovarian syndrome (PCOS) patients may affect the epigenetic status of embryos and lead to the increase of early pregnancy loss rate in PCOS patients. However, there is still no technology using DNA methylome as an indicator in preimplantation embryo screening in PCOS patients. Our recent study showed that using Pre-implantation Methylation Screening (PIMS) can select embryos with better methylation state and euploid chromosomes. The efficiency of PIMS in PCOS patients needs further validation through randomized controlled clinical trial.

The purpose of the study is to compare whether the two groups of PCOS patients who selected embryos using PIMS and selected embryos using "PGT-A + morphology"had any difference in early pregnancy loss rate. This study aims to explore whether PIMS can be used as another embryo evaluation method besides "PGT-A+morphology" to screen good developmental potential embryos in patients with PCOS. Investigators need to clarify whether a better embryo evaluation system can be established through PIMS technology during assisted reproductive treatment for infertile PCOS couples and provide credible and effective evidence-based medical evidence for the application of PMIS technology in the field of reproductive medicine.

Eligibility criteria

Qualifiers

Women aged between 20 and 40 years diagnosed with PCOS according to international evidence-based guidline for assessment and management of policystic ovarian syndrome 2018.

Women who plan to undergo the 1st/2nd IVF/ICSI/PGT-A treatment cycle.

Women who obtain 2 or more blastocysts that have morphological score of 4BC/4CB or better on Day 5of embryo culture.

Culture all the cleavage stage embryos into blastocysts, conduct biopsy on all the blastocysts, and cryopreserve each blastocyst as a single embryo

Disqualifiers

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.

Women who are indicated and planned to undergo preimplantation genetic testing for structural rearrangements (PGT-SR) or preimplantation genetic testing for monogenic (PGT-M).

Women who use donated oocytes or sperm to achieve pregnancy.

Women with contraindication for assisted reproductive technology or for pregnancy, such as 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 carcinoma including including cervical carcinoma, endometrial carcinoma, or breast carcinoma; undiagnosed vaginal bleeding and so on.

Trial design

Treatments tested in this trial

  • PIMS screening
  • PGT-A screening

Treatment groups

766 Participants
are divided into 2 treatment groups

Sponsors and collaborators

First Affiliated Hospital, Sun Yat-Sen University

Lead sponsor

The Third Affiliated Hospital of Guangzhou Medical University

Collaborator

Guangdong Provincial Maternal and Child Health Hospital

Collaborator

Guangzhou Women and Children's Medical Center

Collaborator

Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

Collaborator

Peking University Shenzhen Hospital

Collaborator

BoAi Hospital of Zhongshan

Collaborator

Zhuhai Maternal and Child Health Hospital

Collaborator

Shenzhen Maternal and Child Health Hospital

Collaborator

Liuzhou Hospital of Guangzhou Women and Children's Medical Center

Collaborator

Maternal and Child Health Hospital of Guangxi Zhuang Autonomous Region

Collaborator

Dongguan Maternal and Children Health Hospital

Collaborator