NCT05905289

Brief Summary

Malignant ovarian germ cell tumor patients conducted fertility-sparing surgery and adjuvant chemotherapy in Kasr El-Aini Hospital - Faculty of Medicine - Cairo University from January 2012 to December 2016 will be retrospectively investigated.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
27

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started May 2023

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2023

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

June 7, 2023

Completed
8 days until next milestone

First Posted

Study publicly available on registry

June 15, 2023

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 11, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 11, 2023

Completed
Last Updated

February 9, 2024

Status Verified

February 1, 2024

Enrollment Period

7 months

First QC Date

June 7, 2023

Last Update Submit

February 7, 2024

Conditions

Fertility Issues

Keywords

Ovarian germ cell tumorsFertility sparing

Outcome Measures

Primary Outcomes (1)

  • reproductive outcomes

    To report and analyze reproductive outcome including pregnancy rate and live birth rate after fertility-sparing surgery and adjuvant chemotherapy in malignant ovarian germ cell tumors

    5 years

Secondary Outcomes (1)

  • Clinico-pathological characteristics of MOGCTs.

    5 years

Study Arms (1)

group A

young female patients diagnosed with malignant ovarian germ cell tumors underwent fertility-sparing surgery and adjuvant chemotherapy will be retrospectively investigated

Other: observational study

Interventions

observational studyOTHER

no intervention as it is an observational study

group A

Eligibility Criteria

Age18 Years - 35 Years
Sexfemale
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
Study Population

Malignant ovarian germ cell tumor patients conducted fertility-sparing surgery and adjuvant chemotherapy with complete follow up data from January 2012 to December 2016 will be retrospectively investigated.

You may qualify if:

  • Age : younger than 35 years old at first treatment.
  • Fertility-sparing surgery and adjuvant chemotherapy.
  • Pathological diagnosis of malignant ovarian germ cell tumor.

You may not qualify if:

  • Patients with benign ovarian germ cell tumors e.g. mature teratoma.
  • Concurrent malignancy.
  • Severe comorbidities that may affect ovarian reproductive function.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Obstetrics & Gynecology

Cairo, Egypt

Location

MeSH Terms

Conditions

Infertility

Interventions

Observation

Condition Hierarchy (Ancestors)

Genital DiseasesUrogenital Diseases

Intervention Hierarchy (Ancestors)

MethodsInvestigative Techniques

Study Officials

  • Mahmoud Ahmed Abd El Hameed, MD

    Kasr Al Ainy Hospital, Faculty of Medicine, Cairo University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

June 7, 2023

First Posted

June 15, 2023

Study Start

May 1, 2023

Primary Completion

December 11, 2023

Study Completion

December 11, 2023

Last Updated

February 9, 2024

Record last verified: 2024-02

Data Sharing

IPD Sharing
Will not share

Locations

EG(1)