Fertility Preservation Surgery Clinical Trial
Official title:
The Clinical Significance of Ovarian Function Detection and Protection in Fertility Preservation Surgery for Ovarian Malignancy
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
Status | Not yet recruiting |
Enrollment | 20 |
Est. completion date | April 1, 2021 |
Est. primary completion date | March 15, 2021 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 1 Year to 90 Years |
Eligibility |
Inclusion Criteria: 1. Volunteer to participate in the study with informed consent; 2. Females aged 10-90 who are confirmed with ovarian malignancy and are willing to receive GnRHa experimentally to preserve their fertility function. Exclusion Criteria: 1. Pregnancy, lactation and postmenopause; 2. Suspected or identified as other tumors of genital tract; 3. History of hyperparathyroidism, infectious diseases (tuberculosis, AIDS), autoimmune diseases, or digestive system diseases (malabsorption, crohn disease and dysentery); 4. Other diseases or heavy injuries that will interfere with the results; 5. Simultaneous participation in another clinical study with investigational medicinal product(s) or researcher thinks the subjects are not suitable for this trial. |
Country | Name | City | State |
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n/a |
Lead Sponsor | Collaborator |
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Second Affiliated Hospital of Wenzhou Medical University |
Type | Measure | Description | Time frame | Safety issue |
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Primary | 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 | |
Primary | 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 | |
Primary | 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 |