The Clinical Significance of Ovarian Function Detection and Protection in Fertility Preservation Surgery for Ovarian Malignancy

Study Overview
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Brief Summary
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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

Detailed Description
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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.

Official Title
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The Clinical Significance of Ovarian Function Detection and Protection in Fertility Preservation Surgery for Ovarian Malignancy

Conditions
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Fertility Preservation Surgery, Ovarian Malignancy

Intervention / Treatment
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* Drug: GnRHa


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Volunteer to participate in the study with informed consent; Females aged 10-90 who are confirmed with ovarian malignancy and are willing to receive GnRHa experimentally to preserve their fertility function. Exclusion Criteria: Pregnancy, lactation and postmenopause; Suspected or identified as other tumors of genital tract; History of hyperparathyroidism, infectious diseases (tuberculosis, AIDS), autoimmune diseases, or digestive system diseases (malabsorption, crohn disease and dysentery); Other diseases or heavy injuries that will interfere with the results; Simultaneous participation in another clinical study with investigational medicinal product(s) or researcher thinks the subjects are not suitable for this trial.

Ages Eligible for Study
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Minimum Age: 1 Year
Maximum Age: 90 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: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: group 1<br> | |
| Experimental: group 2<br> | Drug: GnRHa<br>* patients in the experimental group are supposed to receive GnRHa preoperatively and postoperatively according to their individual situation<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 |