Fertility Preservation Surgery, Ovarian Malignancy
Conditions
Brief summary
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
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.
Interventions
DRUGGnRHa
patients in the experimental group are supposed to receive GnRHa preoperatively and postoperatively according to their individual situation
Sponsors
Second Affiliated Hospital of Wenzhou Medical University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
1 Years to 90 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| the content of FSH(mIU/mL), LH(mIU/mL), E2(pmol/L), P(nmol/L), T(nmol/L) and PRL(nmol/L) | 1 year during the perioperative period | by monitoring six above-mentioned hormones preoperatively and postoperatively, the ovarian function is evaluated |
| the volume of ovary(cm*cm*cm) | 1 year during the perioperative period | by monitoring the change of ovarian form and volume, we evaluate the physical ovarian transformation |
| the ovulating period | 1 year during the perioperative period | by comparing the ovulating period perioperatively and postoperatively between two groups, we assess the GnRHa effect on the reproductive function |
Contacts
Primary ContactYu ZHAO, Ph.D
Backup ContactQiong ZHANG, Ph.D
Outcome results
None listed