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| ID | Type | Description | Link |
|---|---|---|---|
| ChiCTR-TRC-00000068 |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | Patients in this arm will be treated with goserelin depot-3.6mg plus add-back therapy. |
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| 2 | No Intervention | 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| gonadotropin-releasing-hormone agonist (GnRHa) - Goserelin | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| The recurrent rate of advanced endometriosis | within one year after surgery or GnRH-a management |
| Measure | Description | Time Frame |
|---|---|---|
| The pregnancy rate following laparoscopic surgery for advanced endometriosis | within one year after surgery or GnRH-a treatment |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Xinmei Zhang, Prof. | Contact | 0086-571-87061501 | 2131 | zhangxinm@zju.edu.cn |
| Name | Affiliation | Role |
|---|---|---|
| Xinmei Zhang, Prof. | Women's Hospital School Of Medicine Zhejiang University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Women's Hospital School Of Medicine Zhejiang University | Recruiting | Hangzhou | Zhejiang | 310006 | China |
| Type | Date | Date Unknown |
|---|---|---|
| Release | Apr 26, 2011 | |
| Reset | May 20, 2011 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Apr 26, 2011 | May 20, 2011 |
| ID | Term |
|---|---|
| D004715 | Endometriosis |
| D012008 | Recurrence |
| ID | Term |
|---|---|
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
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| ID | Term |
|---|---|
| D007987 | Gonadotropin-Releasing Hormone |
| D017273 | Goserelin |
| D002119 | Calcium Carbonate |
| C027385 | tibolone |
| ID | Term |
|---|---|
| D010906 | Pituitary Hormone-Releasing Hormones |
| D007028 | Hypothalamic Hormones |
| D036361 | Peptide Hormones |
| D006728 | Hormones |
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|
| D000091662 | Genital Diseases |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D006730 |
| Hormones, Hormone Substitutes, and Hormone Antagonists |
| D009479 | Neuropeptides |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D009842 | Oligopeptides |
| D009419 | Nerve Tissue Proteins |
| D011506 | Proteins |
| D017610 | Calcium Compounds |
| D007287 | Inorganic Chemicals |
| D002254 | Carbonates |
| D002255 | Carbonic Acid |
| D017554 | Carbon Compounds, Inorganic |
| D008903 | Minerals |