Zhongshan Boai Hospital
Zhongshan, Guangdong, China
Location status: Recruiting
NCT Number: NCT06887881
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.
Interested in participating?
Request Info20 year–40 year
Female
Interventional
Not applicable
Zhongshan, Guangdong, China
Location status: Recruiting
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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
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.
Time frame: From enrollment to the end of treatment at 12months
early pregnancy loss rate in one year after randomization
Time frame: From enrollment to the end of treatment at 12months
cumulative live birth rate per oocyte retrieval cycle in one year after randomization
Time frame: From enrollment to the end of treatment at 12months
Time frame: From enrollment to the end of treatment at 12months
Time frame: From enrollment to the end of treatment at 12months
Time frame: From enrollment to the end of treatment at 12months
Time frame: From enrollment to the end of treatment at 12months
Time frame: From enrollment to the end of treatment at 12months
Time frame: From enrollment to the end of treatment at 12months
First Affiliated Hospital, Sun Yat-Sen University
Other
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
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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