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| Name | Class |
|---|---|
| The Third Affiliated Hospital of Guangzhou Medical University | OTHER |
| Guangdong Provincial Maternal and Child Health Hospital | OTHER |
| Guangzhou Women and Children's Medical Center | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PIMS Group | Experimental | 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. |
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| PGT-A Group | Active Comparator | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PIMS screening | Genetic | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| early pregnancy loss rate | early pregnancy loss rate in one year after randomization | From enrollment to the end of treatment at 12months |
| cumulative live birth rate per oocyte retrieval cycle | cumulative live birth rate per oocyte retrieval cycle in one year after randomization | From enrollment to the end of treatment at 12months |
| Measure | Description | Time Frame |
|---|---|---|
| clinical pregnancy rate after initial embryo transfer | From enrollment to the end of treatment at 12months | |
| time to get live birth | From enrollment to the end of treatment at 12months | |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Zhongshan Boai Hospital | Recruiting | Zhongshan | Guangdong | China |
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| Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University | OTHER |
| Peking University Shenzhen Hospital | OTHER |
| BoAi Hospital of Zhongshan | OTHER |
| Zhuhai Maternal and Child Health Hospital | UNKNOWN |
| Shenzhen Maternal and Child Health Hospital | UNKNOWN |
| Liuzhou Hospital of Guangzhou Women and Children's Medical Center | UNKNOWN |
| Maternal and Child Health Hospital of Guangxi Zhuang Autonomous Region | OTHER |
| Dongguan Maternal and Children Health Hospital | OTHER |
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| PGT-A screening | Genetic | 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. |
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| the rate of a Good Birth Outcome |
| From enrollment to the end of treatment at 12months |
| multiple pregnancy rate | From enrollment to the end of treatment at 12months |
| duration of pregnancy | From enrollment to the end of treatment at 12months |
| birth weight | From enrollment to the end of treatment at 12months |
| incidence of maternal and neonatal complications (including fetal anomalies) | From enrollment to the end of treatment at 12months |