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

Not Applicable

• Conditions: Ovarian Malignancy; Fertility Preservation Surgery
• Interventions: Drug: GnRHa

• Registration Number: NCT03882190
• Lead Sponsor: Second Affiliated Hospital of Wenzhou Medical University

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.

Study Timeline

• Status Verified: 2019-03
• Study First Submitted: 2019-03-17
• Study First Submitted QC: 2019-03-17
• Last Update Submitted: 2019-03-17
• Study First Posted: 2019-03-20
• Last Update Posted: 2019-03-20
• Study Start: 2019-04-01
• Primary Completion: 2021-03-15
• Study Completion: 2021-04-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 20

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
group 2	GnRHa	-

Primary Outcome Measures

Name	Time	Method
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
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