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Association Between Embryo Implantation Rate and Maternal Age

Sponsor
Nanjing University (Other)
Overall Status
Completed
CT.gov ID
NCT05232019
Collaborator
(none)
17,394
Enrollment
1
Location
72
Actual Duration (Months)
241.6
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

To explore the relationship between maternal age and embryo implantation rate in patients undergoing assisted reproductive technology.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    The investigators designed a retrospective clinical trial conducted from January 2015 to December 2020 at the Reproductive Medicine Center of the Affiliated Drum Tower Hospital of Nanjing University Medical School. Infertility was defined as the failure of a clinical pregnancy after 12 months or more of regular unprotected intercourse with the same marriage partner. Patients experiencing infertility no younger than the age of 20 who attended the Reproductive Medicine Center of the Affiliated Drum Tower Hospital of Nanjing University Medical School for the first time and had experienced no less than one embryo transplantation between January 2015 and December 2019 were recruited. Patients who had experienced or canceled embryo transplantation cycles for any reason were excluded from this study. The gap year from December 2019 to December 2020 allowed researchers to follow up on the outcomes of pregnancies before 2020. Frozen cycles were performed when high-quality embryos existed to avoid unnecessary ovarian stimulation and oocyte retrieval processes. Investigators were blinded to the outcome of embryo transplantation, and information on pregnancy was gathered through telephone follow-up one year after transplantation.

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    17394 participants
    Observational Model:
    Cohort
    Time Perspective:
    Retrospective
    Official Title:
    Association Between Embryo Implantation Rate and Maternal Age in Different Embryo Transplantation Cycles: a Retrospective Cohort Study
    Actual Study Start Date :
    Jan 1, 2015
    Actual Primary Completion Date :
    Dec 31, 2019
    Actual Study Completion Date :
    Dec 31, 2020

    Arms and Interventions

    Arm Intervention/Treatment
    Infertile females

    No less than 20 years old who were attending our clinical center for the first time were enlisted

    Outcome Measures

    Primary Outcome Measures

    1. embryo implantation rate [60 days after embryo transplantation]

      Fetal heartbeat can be visualized via ultrasound in order to definitely confirm the implantation of the embryo

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    20 Years to 50 Years
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    1. infertile patients

    2. attended the Reproductive Medicine Center of the Affiliated Drum Tower Hospital of Nanjing University Medical School for the first time

    3. had experienced no less than one embryo transplantation between January 2015 and December 2019

    Exclusion Criteria:

    canceled embryo transplantation cycles for any reason

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Reproductive Medicine Center, The affiliated Drum Towel Hospital of Nanjing University Medical School Nanjing Jiangsu China 210008

    Sponsors and Collaborators

    • Nanjing University

    Investigators

    • Study Director: Haixiang Sun, PhD, The affiliated Drum Towel Hospital of Nanjing University Medical School

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Li-jun Ding, Principal Investigator of Reproductive Medicine Center of The Affiliated Drum Tower Hospital of Nanjing University Medical School, Nanjing University
    ClinicalTrials.gov Identifier:
    NCT05232019
    Other Study ID Numbers:
    • SZ-2021-RIF
    First Posted:
    Feb 9, 2022
    Last Update Posted:
    Feb 22, 2022
    Last Verified:
    Feb 1, 2022
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Infertility
    Infertility, Female

    Study Results

    No Results Posted as of Feb 22, 2022