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

Fertility Preservation Surgery Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03882190
• Other study ID #: SAHoWMU-CR2019-07-101
• Status: Not yet recruiting
• Phase: N/A
• Start date: April 1, 2019
• Est. completion date: April 1, 2021

Study information

• Verified date: March 2019
• Source: Second Affiliated Hospital of Wenzhou Medical University
• Contact: Yu ZHAO, Ph.D
• Phone: 13777760306
• Email: zhaoyu196035[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• 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.

Related Conditions & MeSH terms

• Fertility Preservation Surgery
• Neoplasms
• Ovarian Malignancy

Intervention

Drug:
• GnRHa
patients in the experimental group are supposed to receive GnRHa preoperatively and postoperatively according to their individual situation

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Second Affiliated Hospital of Wenzhou Medical University

Outcome

Type	Measure	Description	Time frame	Safety issue
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