Clinical trial · Observational
Ovarian Function of Nasopharyngeal Carcinoma Women Survivors
Effects of Radiotherapy and Chemotherapy on Ovarian Function and Post-treatment Pregnancy Outcomes in Women With Nasopharyngeal Carcinoma
NCT05183724CI-TRIAL-00055911unknownClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This is an observational cohort study aimed to explore the fertility concerns, fertility preservation strategies, fertility status (pregnancy and Ovarian Failure) and birth outcome among young woman Nasopharyngeal carcinoma patients.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Nasopharyngeal Carcinoma | Nasopharyngeal Carcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (0)
Data not yet available
No intervention recorded.
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Premature Ovarian Failure (POF)
- timeFrame
- 3 years after Radiotherapy
- description
- Premature Ovarian Failure (POF) was defined as menopause before age 40 years. Menopause was defined as cessation of menstruation at least 1 year before the date of the survey in the absence of pregnancy, breastfeeding, continuous use of progestagens or other medication causing amenorrhea, or surgical removal of uterus and/ or ovaries.
Secondary outcomes (5)
- measure
- Progress-Free Survival (PFS)
- timeFrame
- 3 years after Radiotherapy
- description
- Progress-free survival is calculated from the date of registration to the date of the first progress at any site.
- measure
- Pregnancy and birth outcome
- timeFrame
- Within 6 month of diagnosis, or 3-5years after Radiotherapy
- description
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 45 Years
Show eligibility criteria text
Inclusion Criteria: 1. Patients with newly histologically confirmed non-keratinizing nasopharyngeal carcinoma, including WHO II or III ,with no distant metastasis 2. Age between 18-45, female 3. Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0 or 1 4. Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤2.5×upper limit of normal (ULN),serum total bilirubin (TBIL) ≤2.0 times the upper limit of normal (ULN) . 5. Adequate renal function: creatinine clearance rate≥60 ml/min or Creatinine ≤1.5× upper limit of normal value. 6. No history of infertility. 7. No history of hysterectomy or bilateral ovariectomy. 8. Patient have signed on the informed consent, and well understood the objective and procedure of this study Exclusion Criteria: 1. Histologically or cytologically confirmed with keratinizing squamous cell carcinoma of the nasopharynx. 2. Women in the period of pregnancy, lactation, or reproductive without effective contraceptive measures. 3. Known history of other malignancies (except cured basal cell carcinoma or carcinoma in situ of the cervix). 4. Patients with severe dysfunction of heart, liver, lung, kidney or marrow. 5. Patients with severe, uncontrolled disease or infections. 6. Refuse or fail to sign the informed consent . 7. Patients with personality or mental disorders, incapacity or limited capacity for civil conduct.
References
Publications (0)
Data not yet available
No reference posted for this study.