Clinical trial · Observational
Ovarian Reserve After Cancer: Longitudinal Effects
Ovarian Reserve After Cancer: Longitudinal Effects A Multicenter Prospective Cohort Study by the Oncofertility Consortium
NCT02467231CI-TRIAL-00096818ORACLEactive not recruitingClinicalTrials.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)
Women of reproductive age who will receive treatment for cancer that includes chemotherapy may participate in a study measuring ovarian function over time. Eligible women are asked to complete a questionnaire, a menstrual diary, a brief physical examination, an ultrasound, and a blood test before, during and after cancer treatment.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Effects of Chemotherapy | — | UNRESOLVED | — |
| Premature Ovarian Failure | — | UNRESOLVED | — |
Interventions
Interventions (0)
Data not yet available
No intervention recorded.
Design
Arms and outcomes
Arms (1)
- label
- Exposed
- description
- Females ages 11-35 to be exposed to alkylating agent chemotherapy
Primary outcomes (1)
- measure
- Change from baseline in reproductive hormone measures, during and after chemotherapy.
- timeFrame
- 18-30 months: pre-chemotherapy baseline and at 3 month intervals from start of chemotherapy through 6 months after end of chemotherapy.
- description
- 20 mls blood will be obtained at stated timepoints for determining levels of Follicle Stimulating Hormone (FSH), Luteinizing Hormone (LH), Estradiol (E2), Inhibin B, and Anti-mullerian Hormone (AMH). In menstruating girls and young women hormone measures will be obtained during the early follicular phase of the menstrual cycle (days 1-4). In women with irregular cycles the testing will be done spontaneously without regard for the bleeding pattern.
Secondary outcomes (1)
- measure
- Change from baseline in antral follicle counts, during and after chemotherapy.
- timeFrame
- 18-30 months: pre-chemotherapy baseline and at 3 month intervals from start of chemotherapy through 6 months after end of chemotherapy.
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 11 Years
- Maximum age
- 35 Years
Show eligibility criteria text
Inclusion Criteria for exposed population: * Postmenarchal females to be treated with chemotherapy * between the ages of 11-35 years, * with a uterus and at least one ovary Inclusion Criteria for unexposed population: * healthy postmenarchal females * no prior or planned exposure to chemotherapy * between the ages of 11-35, * with a uterus and at least one ovary * regular menstrual cycles (21-35 days) Exclusion criteria for all subjects: * positive pregnancy test at enrollment * lactation within the previous 1 month, * previous treatment with chemotherapy or radiation therapy with the exception of radioactive iodine for thyroid cancer. * previous diagnosis of an illness associated with premature ovarian failure (Turner's syndrome, Fragile X permutation carrier) * endocrine disorder associated with irregular menstrual cycles (Cushing's disease, Thyroid disease, hyper-prolactinemia, congenital adrenal hyperplasia). Additional exclusions for the unexposed population: * a history of infertility, defined as at least 12 months of unprotected intercourse without conception * polycystic ovary syndrome (PCOS)
References
Publications (2)
- BACKGROUNDDillon KE, Sammel MD, Prewitt M, Ginsberg JP, Walker D, Mersereau JE, Gosiengfiao Y, Gracia CR. Pretreatment antimullerian hormone levels determine rate of posttherapy ovarian reserve recovery: acute changes in ovarian reserve during and after chemotherapy. Fertil Steril. 2013 Feb;99(2):477-83. doi: 10.1016/j.fertnstert.2012.09.039. Epub 2012 Oct 18. PMID 23084267
- DERIVEDCameron K, Sammel MD, Prewitt M, Gracia C. Differential Rates of Change in Measures of Ovarian Reserve in Young Cancer Survivors Across the Reproductive Lifespan. J Clin Endocrinol Metab. 2019 May 1;104(5):1813-1822. doi: 10.1210/jc.2018-02257. PMID 30566616