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

Recurrent Early Pregnancy Loss Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04643938
• Other study ID #: 2019SZ-076
• Status: Completed
• Start date: January 1, 2020
• Est. completion date: February 1, 2020

Study information

• Verified date: November 2020
• Source: Peking University Third Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 69
• Est. completion date: February 1, 2020
• Est. primary completion date: January 1, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 20 Years to 46 Years

Eligibility

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.

Related Conditions & MeSH terms

• Abortion, Habitual
• Abortion, Spontaneous
• Recurrent Early Pregnancy Loss

Locations

Country	Name	City	State
China	Center of Reproductive Medicine, Peking University Third Hospital	Beijing	Haidian

Sponsors (1)

Lead Sponsor	Collaborator
Peking University Third Hospital

Country where clinical trial is conducted

China, 

Outcome

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