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

Sponsor
Peking University Third Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT04643938
Collaborator
(none)
69
Enrollment
1
Location
1
Actual Duration (Months)
67.7
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

    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 Design

    Study Type:
    Observational
    Actual Enrollment :
    69 participants
    Observational Model:
    Case-Only
    Time Perspective:
    Prospective
    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
    Actual Study Start Date :
    Jan 1, 2020
    Actual Primary Completion Date :
    Jan 1, 2020
    Actual Study Completion Date :
    Feb 1, 2020

    Arms and Interventions

    Arm Intervention/Treatment
    Two spontaneous abortions

    No intervention
    three spontaneous abortions

    No intervention
    Four or more spontaneous abortions

    No intervention

    Outcome Measures

    Primary Outcome Measures

    1. Baseline characteristics [January 2012 to December 2016]

      Age

    2. Baseline characteristics [January 2012 to December 2016]

      basal sex hormone

    3. Baseline characteristics [January 2012 to December 2016]

      the number of abortion

    4. laboratory outcomes of patients [January 2012 to December 2016]

      Oocyte count

    5. laboratory outcomes of patients [January 2012 to December 2016]

      Number of blastocysts

    6. clinical outcoms [January 2012 to January 2020]

      normal karyotype blastocyst rate

    7. clinical outcoms [January 2012 to January 2020]

      live birth rate

    8. clinical outcoms [January 2012 to January 2020]

      Cumulative pregnancy rate

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    20 Years to 46 Years
    Sexes Eligible for Study:
    Female
    Accepts 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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Center of Reproductive Medicine, Peking University Third Hospital Beijing Haidian China 100191

    Sponsors and Collaborators

    • Peking University Third Hospital

    Investigators

    • Principal Investigator: Haiyan Wang, M.D., Center of Reproductive Medicine, Peking University Third Hospital

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Wang Haiyan, Professor, Peking University Third Hospital
    ClinicalTrials.gov Identifier:
    NCT04643938
    Other Study ID Numbers:
    • 2019SZ-076
    First Posted:
    Nov 25, 2020
    Last Update Posted:
    Nov 25, 2020
    Last Verified:
    Nov 1, 2020
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Abortion, Spontaneous
    Abortion, Habitual
    Recurrence

    Study Results

    No Results Posted as of Nov 25, 2020