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Reproductive Outcome of EM Treated by GnRH-a Associated With Laparoscopy

Primary Purpose

Infertility Associated With Endometriosis

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Goserelin Acetate
Sponsored by
Peking University People's Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Infertility Associated With Endometriosis focused on measuring GnRH-a, endometriosis, efficiency

Eligibility Criteria

20 Years - 35 Years (Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • Infertile patients
  • Endometriosis I-II phase：according to Revised American Society for Reproductive Medicine classification of endometriosis: 1996
  • BMI:19-28 kg/㎡
  • Ovarian reserve function is normal（M2-5：bilateral antral follicles≥6 FSH：5-12U/ml）

Exclusion Criteria:

  • Male factor causes infertility
  • hydrosalpinx or salpingemphraxis
  • Uterine malformation
  • Uterine cavity lesion
  • Contra-indications for GnRH-a
  • not willing to participate

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    No Intervention

    Arm Label

    GnRH-a

    non GnRH-a

    Arm Description

    patients treated with GnRH-a after surgery and Outpatient guidance .

    patients treated with outpatient guidance only.

    Outcomes

    Primary Outcome Measures

    Cumulative pregnancy rate
    Cumulative pregnancy rate of 18 month after surgery
    Time interval between surgery and natural pregnancy
    Time interval between surgery and natural pregnancy
    miscarriage rate
    miscarriage rate of patients who get natural pregnancy

    Secondary Outcome Measures

    Full Information

    First Posted
    May 18, 2016
    Last Updated
    May 19, 2016
    Sponsor
    Peking University People's Hospital
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02779387
    Brief Title
    Reproductive Outcome of EM Treated by GnRH-a Associated With Laparoscopy
    Official Title
    Efficacy of Laparoscopic Surgery Combined With GnRH-a in the Treatment of Endometriosis Associated Infertility: A Multicenter, Prospective, Randomized-control-trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    May 2016
    Overall Recruitment Status
    Unknown status
    Study Start Date
    May 2016 (undefined)
    Primary Completion Date
    May 2020 (Anticipated)
    Study Completion Date
    May 2021 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Peking University People's Hospital

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    This study is a multicenter, randomized-control-trial. This study select 1184 Infertile patients associated with endometriosis diagnosed by laparoscopy surgery. Patients are going to be divided into two groups according to 1:1 ratio randomly assigned to receive GnRH-a. Cumulative pregnancy rate, end of treatment to natural pregnancy time, accept the assisted reproductive treatment rate, miscarriage rate, live birth rate will be recorded.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Infertility Associated With Endometriosis
    Keywords
    GnRH-a, endometriosis, efficiency

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    1184 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    GnRH-a
    Arm Type
    Experimental
    Arm Description
    patients treated with GnRH-a after surgery and Outpatient guidance .
    Arm Title
    non GnRH-a
    Arm Type
    No Intervention
    Arm Description
    patients treated with outpatient guidance only.
    Intervention Type
    Drug
    Intervention Name(s)
    Goserelin Acetate
    Primary Outcome Measure Information:
    Title
    Cumulative pregnancy rate
    Description
    Cumulative pregnancy rate of 18 month after surgery
    Time Frame
    18 month after surgery
    Title
    Time interval between surgery and natural pregnancy
    Description
    Time interval between surgery and natural pregnancy
    Time Frame
    18 month after surgery
    Title
    miscarriage rate
    Description
    miscarriage rate of patients who get natural pregnancy
    Time Frame
    18 month after surgery

    10. Eligibility

    Sex
    Female
    Minimum Age & Unit of Time
    20 Years
    Maximum Age & Unit of Time
    35 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Infertile patients Endometriosis I-II phase：according to Revised American Society for Reproductive Medicine classification of endometriosis: 1996 BMI:19-28 kg/㎡ Ovarian reserve function is normal（M2-5：bilateral antral follicles≥6 FSH：5-12U/ml） Exclusion Criteria: Male factor causes infertility hydrosalpinx or salpingemphraxis Uterine malformation Uterine cavity lesion Contra-indications for GnRH-a not willing to participate

    12. IPD Sharing Statement

    Plan to Share IPD
    Yes
    IPD Sharing Plan Description
    Willing to share IPD

    Learn more about this trial

    Reproductive Outcome of EM Treated by GnRH-a Associated With Laparoscopy

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