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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Endometriosis

Intervention / Treatment
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* Drug: gonadotropin-releasing-hormone agonist (GnRHa) - Goserelin


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Patients in this arm will be treated with goserelin depot-3.6mg plus add-back therapy. | Drug: gonadotropin-releasing-hormone agonist (GnRHa) - Goserelin<br>* 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.<br>* Other names: Livial;|
| No Intervention: 2<br>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?
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Primary Outcome Measures

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

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Endometriosis, Recurrence, Pregnancy Rate, Laparoscopy, Gonadotropin-Releasing Hormone