NCT03882190

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

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Apr 2019

Typical duration for not_applicable

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 17, 2019

Completed
3 days until next milestone

First Posted

Study publicly available on registry

March 20, 2019

Completed
12 days until next milestone

Study Start

First participant enrolled

April 1, 2019

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 15, 2021

Completed
17 days until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2021

Completed
Last Updated

March 20, 2019

Status Verified

March 1, 2019

Enrollment Period

2 years

First QC Date

March 17, 2019

Last Update Submit

March 17, 2019

Conditions

Fertility Preservation SurgeryOvarian Malignancy

Outcome Measures

Primary Outcomes (3)

  • 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

  • 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

  • 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

Study Arms (2)

group 1

NO INTERVENTION

group 2

EXPERIMENTAL
Drug: GnRHa

Interventions

GnRHaDRUG

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

group 2

Eligibility Criteria

Age1 Year - 90 Years
Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Volunteer to participate in the study with informed consent;
  • Females aged 10-90 who are confirmed with ovarian malignancy and are willing to receive GnRHa experimentally to preserve their fertility function.

You may not qualify if:

  • Pregnancy, lactation and postmenopause;
  • Suspected or identified as other tumors of genital tract;
  • History of hyperparathyroidism, infectious diseases (tuberculosis, AIDS), autoimmune diseases, or digestive system diseases (malabsorption, crohn disease and dysentery);
  • Other diseases or heavy injuries that will interfere with the results;
  • Simultaneous participation in another clinical study with investigational medicinal product(s) or researcher thinks the subjects are not suitable for this trial.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Central Study Contacts

Yu ZHAO, Ph.D

CONTACT

13777760306zhaoyu196035@163.com

Qiong ZHANG, Ph.D

CONTACT

13587605820joan_zhang2002@sina.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 17, 2019

First Posted

March 20, 2019

Study Start

April 1, 2019

Primary Completion

March 15, 2021

Study Completion

April 1, 2021

Last Updated

March 20, 2019

Record last verified: 2019-03