Clinical trial NCT04643938: PGT-A in Screening of Embryos in the Treatment of Unexplained Recurrent Miscarriage
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Recurrent Early Pregnancy Loss
Lead sponsor: Peking University Third Hospital
Sponsor class: OTHER
First posted: 2020-11-25
Enrollment: 69
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 46
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Baseline characteristics
timeFrame: January 2012 to December 2016
measure: Baseline characteristics
timeFrame: January 2012 to December 2016
measure: Baseline characteristics
timeFrame: January 2012 to December 2016
measure: laboratory outcomes of patients
timeFrame: January 2012 to December 2016
measure: laboratory outcomes of patients
timeFrame: January 2012 to December 2016
measure: clinical outcoms
timeFrame: January 2012 to January 2020
measure: clinical outcoms
timeFrame: January 2012 to January 2020
measure: clinical outcoms
timeFrame: January 2012 to January 2020
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: Center of Reproductive Medicine, Peking University Third Hospital
state: Haidian
Study officials:
affiliation: Center of Reproductive Medicine, Peking University Third Hospital
name: Haiyan Wang, M.D.
role: PRINCIPAL_INVESTIGATOR
References: