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Etonogestrel Implants Protect Ovarian Reserve Function in Systemic Lupus Erythematosus

Primary Purpose

Systemic Lupus Erythematosus

Status
Not yet recruiting
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Etonogestrel
Sponsored by
Sixth Affiliated Hospital, Sun Yat-sen University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Systemic Lupus Erythematosus

Eligibility Criteria

18 Years - 37 Years (Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria: Systemic lupus erythematosus was confirmed 18-37 years old Exclusion Criteria: History of sex chromosome abnormalities History of abnormal thyroid function History of abnormal adrenal function History of pituitary disease History of sexual hormone drug use in the past 3 months History of ovarian tumors or invasive ovarian operations Pregnancy Have a birth plan in the next 1 year Ovarian failure

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    No Intervention

    Arm Label

    Etonogestrel implants group

    control group

    Arm Description

    Women will be subjected to etonogestrel implant (68mg) insertion.

    This group of women will not be intervened.

    Outcomes

    Primary Outcome Measures

    Anti-Mullerian hormone (AMH) serum level
    The serum AMH levels of the two groups will be compared one year and three months after enrollment.

    Secondary Outcome Measures

    Number of antral follicle
    The number of antral follicles will be recorded by transvaginal ultrasound and compared one year and three months after enrollment.
    Follicle-stimulating hormone (FSH) serum level
    The serum FSH levels of the two groups will be compared one year and three months after enrollment.
    luteinizing hormone (LH) serum level
    The serum LH levels of the two groups will be compared one year and three months after enrollment.
    Estradiol (E2) serum level
    The serum E2 levels of the two groups will be compared one year and three months after enrollment.

    Full Information

    First Posted
    February 1, 2023
    Last Updated
    March 17, 2023
    Sponsor
    Sixth Affiliated Hospital, Sun Yat-sen University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05791799
    Brief Title
    Etonogestrel Implants Protect Ovarian Reserve Function in Systemic Lupus Erythematosus
    Official Title
    A Multicenter Prospective Randomized Controlled Clinical Study of Etonogestrel Implants to Protect Ovarian Reserve Function in Systemic Lupus Erythematosus
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    February 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    April 1, 2023 (Anticipated)
    Primary Completion Date
    October 31, 2025 (Anticipated)
    Study Completion Date
    October 31, 2025 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Sixth Affiliated Hospital, Sun Yat-sen University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. Study Description

    Brief Summary
    This clinical trial aims to test in female patients with systemic lupus erythematosus (SLE). The main question it seeks to answer is whether etonogestrel implants can protect ovarian reserve function in patients with SLE. Participants will be randomly divided into a test group and a control group. The test group will be implanted subcutaneously with etongestrel for one year. Researchers won't intervene in the control group. After three months of drug-eluting, researchers will compare measures of ovarian reserve function in the test and control groups to see if etonogestrel implants can protect ovarian reserve function in patients with SLE.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Systemic Lupus Erythematosus

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Phase 2, Phase 3
    Interventional Study Model
    Parallel Assignment
    Masking
    Outcomes Assessor
    Allocation
    Randomized
    Enrollment
    180 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Etonogestrel implants group
    Arm Type
    Experimental
    Arm Description
    Women will be subjected to etonogestrel implant (68mg) insertion.
    Arm Title
    control group
    Arm Type
    No Intervention
    Arm Description
    This group of women will not be intervened.
    Intervention Type
    Drug
    Intervention Name(s)
    Etonogestrel
    Intervention Description
    Etongestrel implant will be implanted subcutaneously in the participant's non-dominant arm for one year
    Primary Outcome Measure Information:
    Title
    Anti-Mullerian hormone (AMH) serum level
    Description
    The serum AMH levels of the two groups will be compared one year and three months after enrollment.
    Time Frame
    one year and three months
    Secondary Outcome Measure Information:
    Title
    Number of antral follicle
    Description
    The number of antral follicles will be recorded by transvaginal ultrasound and compared one year and three months after enrollment.
    Time Frame
    one year and three months
    Title
    Follicle-stimulating hormone (FSH) serum level
    Description
    The serum FSH levels of the two groups will be compared one year and three months after enrollment.
    Time Frame
    one year and three months
    Title
    luteinizing hormone (LH) serum level
    Description
    The serum LH levels of the two groups will be compared one year and three months after enrollment.
    Time Frame
    one year and three months
    Title
    Estradiol (E2) serum level
    Description
    The serum E2 levels of the two groups will be compared one year and three months after enrollment.
    Time Frame
    one year and three months

    10. Eligibility

    Sex
    Female
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    37 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Systemic lupus erythematosus was confirmed 18-37 years old Exclusion Criteria: History of sex chromosome abnormalities History of abnormal thyroid function History of abnormal adrenal function History of pituitary disease History of sexual hormone drug use in the past 3 months History of ovarian tumors or invasive ovarian operations Pregnancy Have a birth plan in the next 1 year Ovarian failure
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Xiaoyan Liang
    Phone
    86 020-38250752
    Email
    liangxy2@mail.sysu.edu.cn

    12. IPD Sharing Statement

    Learn more about this trial

    Etonogestrel Implants Protect Ovarian Reserve Function in Systemic Lupus Erythematosus

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