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PIMS vs PGT-A in Infertile PCOS Patients

StatusRecruiting
PhaseNot applicable
Started
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Record History

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  1. Notable Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of May 2025 to Jun 12, 2025
    • Collaborators: 10 to 11
    v6
  2. Minor Start date: Apr 2025 to May 2025
    • Collaborators expanded, about 68 words
    • Eligibility criteria expanded, about 3 words
    v5
  3. Minor Primary completion date: Dec 2028 to Nov 2028
    • Eligibility criteria shortened, about 12 words
    • Secondary endpoints: 8 to 7
    v4
  4. Notable Primary endpoints: 1 to 2
    • Secondary endpoints reordered
    v3
  5. Notable Primary endpoints: 2 to 1
    • Enrollment target: 672 to 766
    • Eligibility criteria expanded, about 37 words
    • Secondary endpoints: 7 to 8
    v2
  6. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
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
(from sponsor)
PGT-A, PCOS, PIMS
Enrollment 766 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov