Randomized Study of Gonadotropin-releasing-hormone Agonist (GnRH-a) or Expectant Management for Endometriosis

March 14, 2011 updated by: Zhejiang University

A Randomized Study Comparing Goserelin or Expectant Management Following Laparoscopic Surgery for Advanced Endometriosis

The purpose of this study is to identify the recurrent rate and pregnancy rate of advanced endometriosis after laparoscopic surgery plus GnRHa goserelin acetate treatment.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

In order to decrease endometriosis recurrence and enhance pregnancy rate after surgical therapy, it has been proposed to use a post-surgical gonadotropin-releasing-hormone agonist (GnRHa) treatment. Data on the short-term recurrence of advanced endometriosis is rare. Although operative treatment has resulted in increasing pregnancy rate comparing non surgery management for moderate to severe endometriosis, very few data of spontaneous pregnancy rate are available comparing GnRHa treatment or expectant management after surgery treatment. In this situation, the investigators conduct a prospective, randomized, controlled study to determine whether postoperative GnRHa (goserelin acetate) therapy for advanced endometriosis is effective in reducing endometriosis recurrence rate and improving reproductive outcome.

Study Type

Interventional

Enrollment (Anticipated)

60

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Zhejiang
      • Hangzhou, Zhejiang, China, 310006
        • Recruiting
        • Women's Hospital School of Medicine Zhejiang University
        • Contact:
        • Sub-Investigator:
          • Xiufeng Huang, A/Prof.

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

16 years to 38 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Age >=18 years old
  • Normal menstruation for 3 months before enrollment (25-35 days）
  • Advanced endometriosis confirmed histologically (r-AFS score III-IV) with laparoscopy or laparotomy-pelvic pain and/or dysmenorrhea and/or dyspareunia
  • Agreement on the strict follow-up plan
  • Without previous hormonal treatment
  • Using nonhormonal method of contraception during this study

Exclusion Criteria:

  • Serious heart diseases/pulmonary/liver/kidney diseases
  • Previous non-endometriosis relevant surgery possibly influence to abdominal or pelvic pain
  • Suspected malignancy in endometriosis
  • Coagulation disorders with hemorrhagic tendency
  • Pregnancy or lactation
  • Allergy to GnRHa
  • Previous ineffective treatment with GnRHa

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: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
Patients in this arm will be treated with goserelin depot-3.6mg plus add-back therapy.
Drug: gonadotropin-releasing-hormone agonist (GnRHa) - Goserelin
The patient will be managed with GnRH-a injection (Goserelin 3.6mg) every 4 weeks for 6 months plus add-back therapy (Caltrate With Vitamin D 600mg p.o. q.d.& Livial 1.25-2.5mg p.o. q.d.) if needed.
Other Names:
  • Livial
  • Goserelin
  • Caltrate With Vitamin D 600
No Intervention: 2
The patient with advanced endometriosis（stage III-IV）confirmed histologically after conservative laparoscopic surgery will be suggested to prepare for spontaneous pregnancy rather than any medical administration.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
The recurrent rate of advanced endometriosis
Time Frame: within one year after surgery or GnRH-a management
within one year after surgery or GnRH-a management

Secondary Outcome Measures

Outcome Measure
Time Frame
The pregnancy rate following laparoscopic surgery for advanced endometriosis
Time Frame: within one year after surgery or GnRH-a treatment
within one year after surgery or GnRH-a treatment

Collaborators and Investigators

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

Sponsor

Zhejiang University

Investigators

  • Principal Investigator: Xinmei Zhang, Prof., Women's Hospital School of Medicine Zhejiang University

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

March 1, 2008

Primary Completion (Anticipated)

December 1, 2009

Study Completion (Anticipated)

December 1, 2010

Study Registration Dates

First Submitted

April 2, 2008

First Submitted That Met QC Criteria

April 7, 2008

First Posted (Estimate)

April 8, 2008

Study Record Updates

Last Update Posted (Estimate)

March 15, 2011

Last Update Submitted That Met QC Criteria

March 14, 2011

Last Verified

September 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • D8664L0001
  • ChiCTR-TRC-00000068

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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