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

Second Affiliated Hospital of Wenzhou Medical University

Status: Unknown

Conditions: Fertility Preservation Surgery; Ovarian Malignancy

Treatments: Drug: GnRHa

Study type: Interventional

Funder types: Other

Identifiers

NCT03882190

SAHoWMU-CR2019-07-101

Details and patient eligibility

About

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

Full 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.

Enrollment: 20 estimated patients

Sex: Female

Ages: 1 to 90 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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20 participants in 2 patient groups

group 1

No Intervention group

group 2

Experimental group

Treatment:

Drug: GnRHa