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Trial record 7 of 10 for:    zoladex | Endometriosis

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT02779387
Recruitment Status : Not yet recruiting
First Posted : May 20, 2016
Last Update Posted : May 20, 2016
Information provided by (Responsible Party):
Yu xiaoming, Peking University People's Hospital

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.

Condition or disease Intervention/treatment Phase
Infertility Associated With Endometriosis Drug: Goserelin Acetate Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1184 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Efficacy of Laparoscopic Surgery Combined With GnRH-a in the Treatment of Endometriosis Associated Infertility: A Multicenter, Prospective, Randomized-control-trial
Study Start Date : May 2016
Estimated Primary Completion Date : May 2020
Estimated Study Completion Date : May 2021

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: GnRH-a

patients treated with GnRH-a after surgery and Outpatient guidance


Drug: Goserelin Acetate
No Intervention: non GnRH-a
patients treated with outpatient guidance only.

Primary Outcome Measures :
  1. Cumulative pregnancy rate [ Time Frame: 18 month after surgery ]
    Cumulative pregnancy rate of 18 month after surgery

  2. Time interval between surgery and natural pregnancy [ Time Frame: 18 month after surgery ]
    Time interval between surgery and natural pregnancy

  3. miscarriage rate [ Time Frame: 18 month after surgery ]
    miscarriage rate of patients who get natural pregnancy

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 35 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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
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Responsible Party: Yu xiaoming, Clinician from Department of reproductive medicine.Secretary general of Fallopian tube group,Society for reproductive surgery, Peking University People's Hospital Identifier: NCT02779387    
Other Study ID Numbers: PKU01001
First Posted: May 20, 2016    Key Record Dates
Last Update Posted: May 20, 2016
Last Verified: May 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Willing to share IPD
Keywords provided by Yu xiaoming, Peking University People's Hospital:
Additional relevant MeSH terms:
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Antineoplastic Agents, Hormonal
Antineoplastic Agents