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NCT00644683 · ClinicalTrials.gov registry record
A Pilot Observational Study to Assess Changes in Biochemical Parameters of Ovarian Reserve With Chemotherapy
A clinical trial of Breast Cancer, sponsored by Lynn Henry.
- Completed
- Registry status
- 28
- Enrollment target
- 1
- Study location
NCT00644683: Completed study of Breast Cancer, sponsored by Lynn Henry.
NCT00644683 is a study of Breast Cancer that has completed, run by Lynn Henry. The registered enrollment target is 28 participants, below the 2,803-participant average among 1,224 other Breast Cancer trials with a reported enrollment target (99% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00644683, a study of Breast Cancer, has completed, sponsored by Lynn Henry.
- COMPLETED
- Registry status
- 28 participants
- Enrollment target
- 1
- Study location
Study Summary
Premenopausal women who are diagnosed with breast cancer are frequently treated with chemotherapy. Chemotherapy can affect the ovaries, and the effects can range from temporary loss of menstrual periods to permanent menopause. It is difficult to predict how an individual's ovarian function will be affected by chemotherapy. There are a number of hormones which can be measured in the blood which are related to fertility and ovarian function. The levels of these hormones may change with chemotherapy, and may relate to the effect of chemotherapy on the ovaries. In this study, we plan to enroll 28 women ranging in age from 25 to 50 who are diagnosed with breast cancer and will be treated with chemotherapy. We will check blood levels of the hormones before, immediately after, and 1 year after treatment with chemotherapy. We will only be checking these blood tests for this study; the type of chemotherapy given will be up to the patient and her oncologist. We will also ask some questions about factors that can influence the levels of these hormones, such as number of children, age of menopause of other family members, and smoking history. The results from this study will be used to help us develop future studies looking at changes in ovarian function with chemotherapy, and the effects of other breast cancer therapies, such as endocrine therapy, on the ovaries.
Primary Outcome
To generate estimates of serum concentrations of inhibin A, inhibin B, and anti-Mullerian hormone in premenopausal breast cancer patients (25-50 years of age) before, immediately after, and 1 year following completion of chemotherapy. Hypothesis: Serum concentrations of hormones involved in the hypothalamic-pituitary-ovarian axis (anti-Müllerian hormone, inhibin A, inhibin B, and follicle stimulating hormone) are detectable in the serum of all premenopausal women prior to chemotherapy
Conditions Studied
Study Locations (1)
Michigan
- University of Michigan Cancer Center - Ann Arbor
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 28 participants |
| Start Date | 2007-09 |
| Est. Completion | 2013-09 |
What the finished NCT00644683 record still lists
NCT00644683 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 28 participants, a relatively small participant target, below the 2,803-participant average among 1,224 other Breast Cancer trials with a reported enrollment target (99% lower).
The record links to 1 condition, with Breast Cancer appearing as the primary indexed condition, and to 0 interventions.
NCT00644683 reports a single indexed study location in Michigan.
Frequently Asked Questions
What is clinical trial NCT00644683 about?
NCT00644683 is a clinical study titled "A Pilot Observational Study to Assess Changes in Biochemical Parameters of Ovarian Reserve With Chemotherapy". Premenopausal women who are diagnosed with breast cancer are frequently treated with chemotherapy. Chemotherapy can affect the ovaries, and the effects can range from temporary loss of menstrual periods to permanent menopause. It is difficult to predict how an individual's ovarian function will be a...
What is the current status of trial NCT00644683?
This trial is currently completed. The enrollment target is 28 participants. The study started on 2007-09. Estimated completion is 2013-09.
What conditions does trial NCT00644683 study?
This clinical trial studies the following conditions: Breast Cancer.
Who is sponsoring clinical trial NCT00644683?
This trial is sponsored by Lynn Henry, which has 4 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00644683 being conducted?
This trial has 1 study location across Michigan. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Breast Cancer
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT00644683's enrollment target sits among peer trials
28 1005th of 1224 higher than 207 of 1,224 other Breast Cancer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Breast Cancer trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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