Clinical trial · Observational
Ovarian Damage in Young Premenopausal Women Undergoing Chemotherapy for Cancer
Effects of Cytotoxic Chemotherapy on Ovarian Structure and Function
NCT00402935CI-TRIAL-00006546withdrawnClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): slow accrual
Summary
Brief summary (as posted)
RATIONALE: Comparing results of diagnostic procedures, such as ultrasound, done before, during, and after chemotherapy may help doctors learn about the side effects of chemotherapy and help plan the best treatment. PURPOSE: This clinical trial is studying ovarian damage in young premenopausal women undergoing chemotherapy for cancer.
Conditions
Conditions (8)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Leukemia | Leukemia | ONTOLOGY_EXACT | 0.90 |
| Long-term Effects Secondary to Cancer Therapy in Adults | — | UNRESOLVED | — |
| Long-term Effects Secondary to Cancer Therapy in Children | — | UNRESOLVED | — |
| Lymphoma | Lymphoma | ONTOLOGY_EXACT | 0.90 |
| Sexual Dysfunction and Infertility | — | UNRESOLVED | — |
| Sexuality and Reproductive Issues | — | UNRESOLVED | — |
| Unspecified Adult Solid Tumor, Protocol Specific | Adult Solid Neoplasm | ALIAS | 0.85 |
| Unspecified Childhood Solid Tumor, Protocol Specific | Childhood Solid Neoplasm | ALIAS | 0.85 |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| fertility assessment and management | Procedure | — | UNRESOLVED |
| laboratory biomarker analysis | Other | — | UNRESOLVED |
| management of therapy complications | Procedure | — | UNRESOLVED |
| ultrasound imaging | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Incidence of ovarian damage after cytotoxic chemotherapy as determined by changes in ovarian volume, antral follicle count, and follicle-stimulating hormone, estradiol, and inhibin B levels
- timeFrame
- Ultrasound to measure the ovarian volume and count the number of antral follicles at baseline, 3 months after beginning cytotoxic chemotherapy, and at 6 months after completion of treatment. Patients undergo blood collection at the same time points.
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 14 Years
- Maximum age
- 35 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Diagnosis of cancer, including, but not limited to, any of the following: * Acute lymphocytic leukemia * Acute myeloid leukemia * Hodgkin's lymphoma * Must have primary disease with significant chance for long-term survival after therapy * Scheduled to receive chemotherapeutic agents known to be associated with ovarian failure, including any of the following: * Cyclophosphamide * Mechlorethamine hydrochloride * Busulfan * Procarbazine hydrochloride * Chlorambucil * Melphalan * Ifosfamide * Cisplatin * Carboplatin * Postmenarchal and premenopausal PATIENT CHARACTERISTICS: * Female * Weight ≤ 250 pounds * Not pregnant PRIOR CONCURRENT THERAPY: * No prior or concurrent total-body irradiation or radiotherapy to the pelvis * Concurrent bone marrow transplantation allowed * Concurrent oral contraception and/or gonadotropin releasing-hormone analogue allowed
References
Publications (0)
Data not yet available
No reference posted for this study.