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

Completed

• Conditions: Recurrent Early Pregnancy Loss

• Registration Number: NCT04643938
• Lead Sponsor: Peking University Third Hospital

Brief Summary

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

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.

Study Timeline

• Study Start: 2020-01-01
• Primary Completion: 2020-01-01
• Study Completion: 2020-02-01
• Status Verified: 2020-11
• Study First Submitted: 2020-11-03
• Study First Submitted QC: 2020-11-20
• Last Update Submitted: 2020-11-20
• Study First Posted: 2020-11-25
• Last Update Posted: 2020-11-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 69

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.

Read More

Exclusion Criteria

Couples with parental chromosomal abnormalities were excluded, as were women with anatomical abnormalities of the uterus, autoimmune diseases, and endocrine abnormalities.

Read More

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
laboratory outcomes of patients	January 2012 to December 2016	Number of blastocysts
Baseline characteristics	January 2012 to December 2016	the number of abortion
clinical outcoms	January 2012 to January 2020	Cumulative pregnancy rate

Trial Locations

Locations (1)

Center of Reproductive Medicine, Peking University Third Hospital; 🇨🇳 Beijing, Haidian, China