PGT-A in Screening of Embryos in the Treatment of Unexplained Recurrent Miscarriage

Study Overview
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Brief Summary
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uRM patients selected PGT-A from 2012 to 2016 were included in this study. Their clinical outcomes were prospectively observed and analyzed to explore the factor influenced the outcomes.

Detailed Description
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This prospective observational study enrolled all women with uRM who underwent array-comparative genomic hybridization (array-CGH) for PGT-A in the Reproductive Medicine Center of Peking University Third Hospital from 2012 to 2016. If a couple underwent multiple stimulation cycles during the research period, only the first cycle was included. All patients underwent adequate clinical and genetic consultations before undergoing PGT-A, and all voluntarily chose PGT-A after fully understanding its risks and benefits. All patients signed the informed consent document of PGT-A. All included stimulation cycles involved intracytoplasmic sperm injection insemination. After successfully fertilized embryos formed blastocysts on Day 5-7, trophoblasts were biopsied to determine embryonic karyotypes. The blastocysts with normal/balanced test results were cryopreserved, whereas abnormal blastocysts were discarded after notifying the patients. All normal blastocysts from a patient were thawed and transferred singly, and the outcomes of all subsequent frozen-thawed embryo transfer cycles were followed-up until January 2020. Clinical outcomes included the blastocyst formation rate, the proportion of blastocysts with normal karyotypes, and the clinical pregnancy, live birth, and cumulative live birth rates. The factors that affected these clinical outcomes were analyzed to predict outcomes and guide treatment in women with uRM.

Official Title
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Preimplantation Genetic Testing for Aneuploidy in Screening of Embryos in the Treatment of Unexplained Recurrent Miscarriage: a Single-center, Prospective Clinical Analysis Based on aCGH Technology

Conditions
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Recurrent Early Pregnancy Loss

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: women with uRM who underwent array-comparative genomic hybridization (array-CGH) for PGT-A in the Reproductive Medicine Center of Peking University Third Hospital from 2012 to 2016.Only the first cycle was included. All patients underwent adequate clinical and genetic consultations before undergoing PGT-A, and all voluntarily chose PGT-A after fully understanding its risks and benefits. All patients signed the informed consent document of PGT-A. Exclusion Criteria: Couples with parental chromosomal abnormalities were excluded, as were women with anatomical abnormalities of the uterus, autoimmune diseases, and endocrine abnormalities.

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 46 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Two spontaneous abortions<br>No intervention | |
| three spontaneous abortions<br>No intervention | |
| Four or more spontaneous abortions<br>No intervention | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Baseline characteristics | Age | January 2012 to December 2016 | 
| Baseline characteristics | basal sex hormone | January 2012 to December 2016 | 
| Baseline characteristics | the number of abortion | January 2012 to December 2016 | 
| laboratory outcomes of patients | Oocyte count | January 2012 to December 2016 | 
| laboratory outcomes of patients | Number of blastocysts | January 2012 to December 2016 | 
| clinical outcoms | normal karyotype blastocyst rate | January 2012 to January 2020 | 
| clinical outcoms | live birth rate | January 2012 to January 2020 | 
| clinical outcoms | Cumulative pregnancy rate | January 2012 to January 2020 |