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

May 19, 2016 updated by: Yu xiaoming, Peking University People's Hospital

Efficacy of Laparoscopic Surgery Combined With GnRH-a in the Treatment of Endometriosis Associated Infertility: A Multicenter, Prospective, Randomized-control-trial

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

1184

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 35 years (ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cumulative pregnancy rate
Time Frame: 18 month after surgery
Cumulative pregnancy rate of 18 month after surgery
18 month after surgery
Time interval between surgery and natural pregnancy
Time Frame: 18 month after surgery
Time interval between surgery and natural pregnancy
18 month after surgery
miscarriage rate
Time Frame: 18 month after surgery
miscarriage rate of patients who get natural pregnancy
18 month after surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Peking University People's Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2016

Primary Completion (ANTICIPATED)

May 1, 2020

Study Completion (ANTICIPATED)

May 1, 2021

Study Registration Dates

First Submitted

May 18, 2016

First Submitted That Met QC Criteria

May 19, 2016

First Posted (ESTIMATE)

May 20, 2016

Study Record Updates

Last Update Posted (ESTIMATE)

May 20, 2016

Last Update Submitted That Met QC Criteria

May 19, 2016

Last Verified

May 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PKU01001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Willing to share IPD

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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