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NCT Number: NCT04643938

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

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.

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Key information

Conditions

Recurrent Early Pregnancy Loss Abortion, Habitual Abortion, Spontaneous Female Urogenital Diseases and Pregnancy Complications Pregnancy Complications Urogenital Diseases

Age range

20 year–46 year

Sex eligibility

Female

Study type

Observational

Primary location

Center of Reproductive Medicine, Peking University Third Hospital

Beijing, Haidian, 100191, China

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. Baseline characteristics

    Time frame: January 2012 to December 2016

    Age

  2. Baseline characteristics

    Time frame: January 2012 to December 2016

    basal sex hormone

  3. Baseline characteristics

    Time frame: January 2012 to December 2016

    the number of abortion

  4. laboratory outcomes of patients

    Time frame: January 2012 to December 2016

    Oocyte count

  5. laboratory outcomes of patients

    Time frame: January 2012 to December 2016

    Number of blastocysts

  6. clinical outcoms

    Time frame: January 2012 to January 2020

    normal karyotype blastocyst rate

  7. clinical outcoms

    Time frame: January 2012 to January 2020

    live birth rate

  8. clinical outcoms

    Time frame: January 2012 to January 2020

    Cumulative pregnancy rate

Sponsors and collaborators

Lead sponsor

Peking University Third Hospital

Other

Registry information

Official study 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

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Nov 25, 2020
Registry last updated
Nov 25, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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