PIMS vs PGT-A in Infertile PCOS Patients

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.

NCT Number	NCT06887881
Lead Sponsor	First Affiliated Hospital, Sun Yat-Sen University Collaborators: The Third Affiliated Hospital of Guangzhou Medical University, Guangdong Provincial Maternal and Child Health Hospital, Guangzhou Women and Children's Medical Center, Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University, Peking University Shenzhen Hospital, BoAi Hospital of Zhongshan, Zhuhai Maternal and Child Health Hospital, Shenzhen Maternal and Child Health Hospital, Liuzhou Hospital of Guangzhou Women and Children's Medical Center, Maternal and Child Health Hospital of Guangxi Zhuang Autonomous Region, Dongguan Maternal and Children Health Hospital
Conditions	PGT-A, PCOS, PIMS
Enrollment	766 participants
Start Date	2025-06-12
Primary Completion	2028-11 (estimated)
Study Completion	2028-12 (estimated)
Updated on ClinicalTrials.gov	2026-04-02