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Survival and Reproductive Outcomes of Malignant Ovarian Germ Cell Tumors

Survival and Reproductive Outcomes After Fertility-sparing Surgery and Adjuvant Chemotherapy in Malignant Ovarian Germ Cell Tumors

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05905289
Enrollment
27
Registered
2023-06-15
Start date
2023-05-01
Completion date
2023-12-11
Last updated
2024-02-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Fertility Issues

Keywords

Ovarian germ cell tumors, Fertility sparing

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.

Detailed description

MOGCT patients conducted fertility-sparing surgery and adjuvant chemotherapy with complete follow up data, younger than 35 years old at first treatment, in Kasr El-Aini Hospital - Faculty of Medicine - Cairo University ( Department of Obstetrics & Gynecology and Center of Clinical Oncology and Nuclear Medicine ) from January 2012 to December 2016 will be retrospectively investigated. Diagnosis of MOGCT was revealed by pelvic mass, abdominal pain, and elevated tumor markers like α-fetoprotein (AFP), human choionic gonadotophin (HCG) and lactate dehydrogenase (LDH) and confirmed by surgical procedure and pathological diagnosis. Pathological diagnosis was confirmed according to the 2014 World Health Organization classification of tumors of female reproductive organs. Tumors were staged according to American Joint Committee of Cancer (AJCC), TNM and FIGO staging system for Ovarian and Primary Peritoneal Cancer. Fertility sparing surgery preserves uterus and the contralateral ovary with or without comprehensive staging (omentectomy and lymphadenectomy) by open laparotomy. Adjuvant chemotherapy was scheduled based on histopathology, grade and stage. All patients received chemotherapy, but with different schemes and courses The data including: subjects' demographics, clinical and pathological characteristics, treatment received, survival outcome and reproductive outcomes including pregnancy rate ( natural conception ) and live birth rate will be investigated. Follow-up data until January 31, 2022 will be collected from hospital records and telephone interview.

Interventions

OTHERobservational study

no intervention as it is an observational study

Sponsors

Cairo University
Lead SponsorOTHER

Study design

Observational model
OTHER
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 35 Years

Inclusion criteria

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

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frameDescription
reproductive outcomes5 yearsTo 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

Secondary

MeasureTime frameDescription
Clinico-pathological characteristics of MOGCTs.5 yearsthe clinical presentation and histopathological features of MOGCTs.

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026