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

NCT ID: NCT03882190

Last Updated: 2019-03-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-04-01

Study Completion Date

2021-04-01

Brief Summary

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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

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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.

Conditions

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Fertility Preservation Surgery Ovarian Malignancy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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group 1

Group Type NO_INTERVENTION

No interventions assigned to this group

group 2

Group Type EXPERIMENTAL

GnRHa

Intervention Type DRUG

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

Interventions

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GnRHa

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

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

1 Year

Maximum Eligible Age

90 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Second Affiliated Hospital of Wenzhou Medical University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Central Contacts

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Yu ZHAO, Ph.D

Role: CONTACT

13777760306

Qiong ZHANG, Ph.D

Role: CONTACT

13587605820

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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SAHoWMU-CR2019-07-101

Identifier Type: -

Identifier Source: org_study_id

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