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Expression of Endometrium During Window of Implantation

Sponsor
Kaohsiung Veterans General Hospital. (Other)
Overall Status
Recruiting
CT.gov ID
NCT05478616
Collaborator
(none)
60
Enrollment
1
Location
30
Anticipated Duration (Months)
2
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The aim of this study was to investigate the expression of endometrium during window of implantation between natural cycles and artificial cycles.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    Due to progress of embryo vitrification in recent years, frozen embryo transfer (FET) of in vitro fertilization (IVF) has already been a world trend. The most used two protocols of FET are natural cycles (NCs) and artificial cycles (ACs). Recent studies showed that IVF outcomes of NCs were superior to ACs. We hypothesized that the result may be because of better endometrial receptivity of NCs compared to ACs. In NCs, no hormonal agents were administrated. Thus, endometrial receptivity was not disturbed by hormone and became better. However, there were few studies to explore the issue. Therefore, the aim of this study was to investigate the expression of endometrium during window of implantation (WOI) between NCs and ACs.

    The study will be performed from July 1st, 2022 to December 31th, 2023 in our reproductive center. We plan to enroll 60 infertile women who have underwent IVF cycles and would like to receive endometrial receptivity assay. We divide the participants into two groups, NCs and ACs. In NCs, no hormonal agents will be used. We identify ovulation day via serial hormone data and sample endometrium during WOI (LH surge + 7 days). In ACs, first, estrogen will be given for 10~14 days and then transvaginal sonography will be conducted. When endometrial thickness reaches 8 mm at least, progesterone will be prescribed. Endometrium is sampled during WOI (P4 + 5 days). We will record basic characteristics, infertility history, hormone data, ovarian reserve and endometrial thickness of infertile women in both groups. Endometrial samples will be assessed miRNA, implantation factors, uterine NK cells and T cells in both groups.

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    60 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    To Investigate the Expression of Endometrium During Window of Implantation Between Natural Cycles and Artificial Cycles
    Actual Study Start Date :
    Jul 1, 2022
    Anticipated Primary Completion Date :
    Dec 31, 2023
    Anticipated Study Completion Date :
    Dec 31, 2024

    Arms and Interventions

    Arm Intervention/Treatment
    Natural cycles

    Endometrium will be sampled at the day of LH surge + 7 days.
    Artificial cycles

    Endometrium will be sampled at the day of P4 + 5 days.

    Outcome Measures

    Primary Outcome Measures

    1. Expression of endometrium [through study completion, an average of 1.5 year]

      miRNA

    Secondary Outcome Measures

    1. Implantation factors of endometrium [through study completion, an average of 1.5 year]

      HOXA10

    2. Immune cells of endometrium [through study completion, an average of 1.5 year]

      Uterine NK cells

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    30 Years to 44 Years
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • Age: 30-44 years

    • BMI: 18~30 kg/m2

    • Implantation failure at least two times

    Exclusion Criteria:

    • Primary ovarian insufficiency

    • Congenital uterine anomaly

    • Severe intrauterine adhesion

    • Malignancy

    • Donor cycle

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Kaohsiung Veterans General Hospital Kaohsiung City Taiwan 81362

    Sponsors and Collaborators

    • Kaohsiung Veterans General Hospital.

    Investigators

    • Study Director: Li-Te Lin, Kaohsiung Veterans General Hospital.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Li-Te Lin, Attending doctor, Department of Obstetrics and Gynecology, Principal Investigator, Assistant professor, Kaohsiung Veterans General Hospital.
    ClinicalTrials.gov Identifier:
    NCT05478616
    Other Study ID Numbers:
    • KSVGH22-CT7-07
    First Posted:
    Jul 28, 2022
    Last Update Posted:
    Jul 29, 2022
    Last Verified:
    Jul 1, 2022
    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
    Keywords provided by Li-Te Lin, Attending doctor, Department of Obstetrics and Gynecology, Principal Investigator, Assistant professor, Kaohsiung Veterans General Hospital.
    window of implantation
    endometrium receptivity
    frozen embryo transfer cycles
    natural cycles
    artificial cycles
    hormone replacement therapy cycles

    Study Results

    No Results Posted as of Jul 29, 2022