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The design of this prospective interventional study is to investigate the clinical significance of applying GnRHa preoperatively and postoperatively and detecting physical and endocrinic change in fertility preservation surgery
20 patients with ovarian maligancies are anticipated to be enrolled in this study within 2 years. With their permission, they will be randomized into the control group and the experimental group when the latter is supposed to receive GNRHa preoperatively and postoperatively. And their physical and endocrinic indexes will be monitored. The effect of extra use of GnRHa will be observed by comparing these two groups' outcomes.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| group 1 | No Intervention | ||
| group 2 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GnRHa | Drug | patients in the experimental group are supposed to receive GnRHa preoperatively and postoperatively according to their individual situation |
|
| Measure | Description | Time Frame |
|---|---|---|
| the content of FSH(mIU/mL), LH(mIU/mL), E2(pmol/L), P(nmol/L), T(nmol/L) and PRL(nmol/L) | by monitoring six above-mentioned hormones preoperatively and postoperatively, the ovarian function is evaluated | 1 year during the perioperative period |
| the volume of ovary(cm*cm*cm) | by monitoring the change of ovarian form and volume, we evaluate the physical ovarian transformation | 1 year during the perioperative period |
| the ovulating period | by comparing the ovulating period perioperatively and postoperatively between two groups, we assess the GnRHa effect on the reproductive function | 1 year during the perioperative period |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yu ZHAO, Ph.D | Contact | 13777760306 | zhaoyu196035@163.com | |
| Qiong ZHANG, Ph.D | Contact | 13587605820 | joan_zhang2002@sina.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Feb 1, 2019 |
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| Mar 14, 2019 |
| Prot_SAP_000.pdf |