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Trial record 7 of 10 for:    zoladex | Endometriosis
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Reproductive Outcome of EM Treated by GnRH-a Associated With Laparoscopy

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ClinicalTrials.gov Identifier: NCT02779387
Recruitment Status : Not yet recruiting
First Posted : May 20, 2016
Last Update Posted : May 20, 2016
Sponsor:
Information provided by (Responsible Party):
Yu xiaoming, Peking University People's Hospital

Study Description
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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

Study Design
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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

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Arms and Interventions
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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.


Outcome Measures
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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


Eligibility Criteria
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Ages Eligible for Study:   20 Years to 35 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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No Contacts or Locations Provided
More Information
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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
ClinicalTrials.gov 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:
GnRH-a
endometriosis
efficiency
Additional relevant MeSH terms:
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Infertility
Endometriosis
Goserelin
Antineoplastic Agents, Hormonal
Antineoplastic Agents