Clinical trial · Observational
Assessing Urinary Hormones in Female Cancer Survivors
Follicular and Luteal Dysfunction in Cancer Survivors
NCT03197532CI-TRIAL-00048416AUHScompletedClinicalTrials.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 late to mid reproductive age may participate in a study using novel methodology to identify subtle changes in the reproductive endocrine axis via daily urine hormone analysis, which may have important implications for reproduction and may signal reproductive senescence.
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 |
|---|---|---|---|
| Effects of Chemotherapy | — | UNRESOLVED | — |
Interventions
Interventions (0)
Data not yet available
No intervention recorded.
Design
Arms and outcomes
Arms (3)
- label
- Group 1
- description
- Otherwise healthy, mid-reproductive aged women between the ages of 20 and 35 years previously exposed to high dose alkylating agent therapy (or have an alkylator score of 1 or more), and at least 1 year from cancer treatment.
- label
- Group 2
- description
- Healthy, mid-reproductive aged women between the ages of 20 to 35 who have not been exposed to cancer therapy.
- label
- Group 3
- description
- Reproductive aged women between the ages of 43-50 who have not been exposed to cancer therapy, nor have a history of infertility
Primary outcomes (5)
- measure
- Urinary Follicle Stimulating Hormone (FSH)
- timeFrame
- up to 49 days each menstrual cycle
- description
- Integrated urinary follicular-phase Follicle Stimulating Hormone (FSH) in urine samples collected daily for 2 menstrual cycles will be measured in mIU/mL by means of two-site chemiluminescent immunoassay with the use of two monoclonal antibodies.
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 20 Years
- Maximum age
- 50 Years
Show eligibility criteria text
Inclusion Criteria for Group 1: * Otherwise healthy, mid-reproductive aged women between the ages of 20 and 35 years previously exposed to high dose alkylating agent therapy (or have an alkylator score of 1 or more), and at least 1 year from cancer treatment. Inclusion Criteria for Group 2: * Healthy, mid-reproductive aged women between the ages of 20 to 35 who have not been exposed to cancer therapy. Inclusion Criteria for Group 3: * Healthy, late reproductive aged women between the ages of 43-50 who have not been exposed to cancer therapy, nor have a history of infertility. Exclusion Criteria for all subjects: * Pregnancy or lactation within the previous 3 months * Use of hormonal contraception or replacement within the previous 3 months * Body Mass Index greater than 30 kg/m2 * Excessive exercise greater than 1 hour per day * Any medical condition other than cancer known to be associated with premature ovarian failure (such as Turners Syndrome or Fragile X) or ovulatory dysfunction (such as thyroid disease, congenital adrenal hyperplasia, Cushings syndrome, hyperprolactinemia, and polycystic ovary syndrome)
References
Publications (0)
Data not yet available
No reference posted for this study.