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

Primary Purpose

Endometriosis

Status
Unknown status
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
gonadotropin-releasing-hormone agonist (GnRHa) - Goserelin
Sponsored by
Zhejiang University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Endometriosis focused on measuring Endometriosis, Recurrence, Pregnancy Rate, Laparoscopy, Gonadotropin-Releasing Hormone

Eligibility Criteria

18 Years - 40 Years (Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Women's Hospital School Of Medicine Zhejiang UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

1

2

Arm Description

Patients in this arm will be treated with goserelin depot-3.6mg plus add-back therapy.

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.

Outcomes

Primary Outcome Measures

The recurrent rate of advanced endometriosis

Secondary Outcome Measures

The pregnancy rate following laparoscopic surgery for advanced endometriosis

Full Information

First Posted
April 2, 2008
Last Updated
March 14, 2011
Sponsor
Zhejiang University
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1. Study Identification

Unique Protocol Identification Number
NCT00654524
Brief Title
Randomized Study of Gonadotropin-releasing-hormone Agonist (GnRH-a) or Expectant Management for Endometriosis
Official Title
A Randomized Study Comparing Goserelin or Expectant Management Following Laparoscopic Surgery for Advanced Endometriosis
Study Type
Interventional

2. Study Status

Record Verification Date
September 2008
Overall Recruitment Status
Unknown status
Study Start Date
March 2008 (undefined)
Primary Completion Date
December 2009 (Anticipated)
Study Completion Date
December 2010 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
Zhejiang University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Endometriosis
Keywords
Endometriosis, Recurrence, Pregnancy Rate, Laparoscopy, Gonadotropin-Releasing Hormone

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
Patients in this arm will be treated with goserelin depot-3.6mg plus add-back therapy.
Arm Title
2
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
gonadotropin-releasing-hormone agonist (GnRHa) - Goserelin
Other Intervention Name(s)
Goserelin, Caltrate With Vitamin D 600, Livial
Intervention Description
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.
Primary Outcome Measure Information:
Title
The recurrent rate of advanced endometriosis
Time Frame
within one year after surgery or GnRH-a management
Secondary Outcome Measure Information:
Title
The pregnancy rate following laparoscopic surgery for advanced endometriosis
Time Frame
within one year after surgery or GnRH-a treatment

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Xinmei Zhang, Prof.
Phone
0086-571-87061501
Ext
2131
Email
zhangxinm@zju.edu.cn
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Xinmei Zhang, Prof.
Organizational Affiliation
Women's Hospital School Of Medicine Zhejiang University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Women's Hospital School Of Medicine Zhejiang University
City
Hangzhou
State/Province
Zhejiang
ZIP/Postal Code
310006
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xinmei Zhang, Prof.
Phone
0086-571-87061501
Ext
2131
Email
zhangxinm@zju.edu.cn
First Name & Middle Initial & Last Name & Degree
Xiufeng Huang, A/Prof.

12. IPD Sharing Statement

Learn more about this trial

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

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