Endometriosis
Conditions
Keywords
Endometriosis, Recurrence, Pregnancy Rate, Laparoscopy, Gonadotropin-Releasing Hormone
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.
Interventions
DRUGgonadotropin-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.
Sponsors
Zhejiang University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 40 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The recurrent rate of advanced endometriosis | within one year after surgery or GnRH-a management |
Secondary
| Measure | Time frame |
|---|---|
| The pregnancy rate following laparoscopic surgery for advanced endometriosis | within one year after surgery or GnRH-a treatment |
Countries
China
Contacts
Primary ContactXinmei Zhang, Prof.
Outcome results
None listed