Blood Spot Self-administered Test and Assay
| Status: | Completed |
|---|---|
| Conditions: | Women's Studies |
| Therapuetic Areas: | Reproductive |
| Healthy: | No |
| Age Range: | 18 - 45 |
| Updated: | 2/17/2019 |
| Start Date: | October 2010 |
| End Date: | August 2016 |
The current study will compare hormone levels of AMH, FSH and inhibin B in blood specimens
collected by venipuncture and fingerstick in a sample of pre-menopausal women ages 18-45
years with normal menstrual cycles.
collected by venipuncture and fingerstick in a sample of pre-menopausal women ages 18-45
years with normal menstrual cycles.
Recent advances in cancer diagnosis and treatment have led to greater survival rates in
patients with malignancies. However, these life-saving treatments, especially alkylating
agents, often lead to premature ovarian failure, infertility and related long-term health
problems. It is difficult to predict whether, and the extent to which, patients will
experience these problems. There are no early clinical signs of decreased fertility
potential; even young women who maintain cyclic menses after therapy are at high risk of
infertility, early menopause and related health problems. Preliminary studies suggest that
several surrogate measures of fertility potential are different in cancer survivors compared
with controls. These include follicle stimulating hormone (FSH), estradiol, anti-mullerian
hormone (AMH) and inhibin B. Large longitudinal studies are needed to validate these measures
with gold standard outcomes such as pregnancy rates, pregnancy outcomes and time to
menopause. The main impediment to assessing the value of these markers and generating data
that is useful to cancer survivors is the need for frequent and timed blood samples.
Daily or frequent trips to the clinical center are not practical and reduce the compliance of
even the most motivated patients. The hypothesis that will be tested by this study is that
blood spot assays can be developed that provide robust, personalized data for surrogate
markers of reproductive function which can be used to assess reproductive potential in women;
furthermore, bloodspots collected at home are an acceptable method for reproductive hormone
measurement in women with and without a history of cancer. The current study will compare
hormone levels of AMH, FSH and inhibin B in blood specimens collected by venipuncture and
fingerstick in a sample of subjects.
patients with malignancies. However, these life-saving treatments, especially alkylating
agents, often lead to premature ovarian failure, infertility and related long-term health
problems. It is difficult to predict whether, and the extent to which, patients will
experience these problems. There are no early clinical signs of decreased fertility
potential; even young women who maintain cyclic menses after therapy are at high risk of
infertility, early menopause and related health problems. Preliminary studies suggest that
several surrogate measures of fertility potential are different in cancer survivors compared
with controls. These include follicle stimulating hormone (FSH), estradiol, anti-mullerian
hormone (AMH) and inhibin B. Large longitudinal studies are needed to validate these measures
with gold standard outcomes such as pregnancy rates, pregnancy outcomes and time to
menopause. The main impediment to assessing the value of these markers and generating data
that is useful to cancer survivors is the need for frequent and timed blood samples.
Daily or frequent trips to the clinical center are not practical and reduce the compliance of
even the most motivated patients. The hypothesis that will be tested by this study is that
blood spot assays can be developed that provide robust, personalized data for surrogate
markers of reproductive function which can be used to assess reproductive potential in women;
furthermore, bloodspots collected at home are an acceptable method for reproductive hormone
measurement in women with and without a history of cancer. The current study will compare
hormone levels of AMH, FSH and inhibin B in blood specimens collected by venipuncture and
fingerstick in a sample of subjects.
Inclusion Criteria:
- Adult females
- Age between 18-45 years
- Premenopausal (defined as menses in the past 12 months)
- Postmenarchal
- Presence of an intact uterus and two ovaries
- Ability and willingness to comply with study protocol
Exclusion Criteria:
- Pregnancy within the previous 3 months
- Lactation within the previous 3 months
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