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

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT04643938

Enrollment

Registered

2020-11-25

Start date

2020-01-01

Completion date

2020-02-01

Last updated

2020-11-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Recurrent Early Pregnancy Loss

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.

Interventions

None listed

Study design

Observational model

CASE_ONLY

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

FEMALE

Age

20 Years to 46 Years

Healthy volunteers

Yes

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.

Design outcomes

Primary

Measure	Time frame	Description
Baseline characteristics	January 2012 to December 2016	Age
laboratory outcomes of patients	January 2012 to December 2016	Oocyte count
clinical outcoms	January 2012 to January 2020	normal karyotype blastocyst rate

Countries

China

Outcome results