NCT00654524

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

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

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: Zhejiang University · Academic / Other
• Sex: Female
• Age: 18 Years – 40 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Endometriosis

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2008-03-01
• Primary completion: 2009-12-01
• Completion: 2010-12-01
• First posted: 2008-04-08
• Last updated: 2011-03-15

Locations

1 site across 1 country: China