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Clinical Use of Preimplantation DNA Methylation Screening (PIMS) and Preimplantation Genetics Screening (PGT-A) in Infertile PCOS Patients-A Multicenter, Prospective Randomized Non-inferior Clinical Trial

Status: Recruiting
Location: See location...
Intervention Type: Genetic
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

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 + morphologyhad 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
Participation Requirements
Sex: Female
Minimum Age: 20
Maximum Age: 40
Healthy Volunteers: f
View:

• 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

• Agree to the thawing and transfer of a single blastocyst.

• Sign the informed consent form.

Locations
Other Locations
China
Zhongshan Boai Hospital
RECRUITING
Zhongshan
Time Frame
Start Date: 2025-06-12
Estimated Completion Date: 2028-12
Participants
Target number of participants: 766
Treatments
Experimental: PIMS Group
Couples in the PIMS group will have up to 6 blastocysts screened with PIMS and a single euploid embryo with the optimal state of whole-genome DNA methylation and the highest morphologic score will be selected for the initial transfer. The optimal state of whole-genome DNA methylation includes methylation level closest to the optimal level (0.26 according to our preliminary results) and proper methylation state for some specific regions.Blastocysts that have undergone a second biopsy will not be preferred.
Active_comparator: PGT-A Group
Couples in the PGT-A group will have up to 6 blastocysts screened with PGT-A and a single euploid blastocyst with the highest morphologic score selected for the initial transfer.Blastocysts that have undergone a second biopsy will not be preferred.
Sponsors
Collaborators: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University, Zhuhai Maternal and Child Health Hospital, Guangdong Provincial Maternal and Child Health Hospital, Shenzhen Maternal and Child Health Hospital, Liuzhou Hospital of Guangzhou Women and Children's Medical Center, The Third Affiliated Hospital of Guangzhou Medical University, BoAi Hospital of Zhongshan, Dongguan Maternal and Children Health Hospital, Peking University Shenzhen Hospital, Guangzhou Women and Children's Medical Center, Guangxi Zhuang Autonomous Region Maternal and Child Health Hospital
Leads: First Affiliated Hospital, Sun Yat-Sen University

This content was sourced from clinicaltrials.gov