Blood Spot Self-administered Test and Assay
Condition: Dysfunction; Endocrine; Effects of Chemotherapy; Premature Ovarian Failure
MeSH terms: Primary Ovarian Insufficiency; Menopause, Premature
Study type: Observational

Summary: 
      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.
    

Detailed description: 
      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.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        The target population is 80 pre-menopausal women ages 18-45 years with normal menstrual
        cycles:

        Aim 1: Total 80 subjects:

          -  30 cancer survivors

          -  30 similar aged healthy controls

          -  20 late reproductive aged women

        Aim 2: Subset of 60 subjects:

          -  30 cancer survivors

          -  30 similar aged healthy controls
      
Biospecimen description: 
      whole blood, serum
    
Keywords: healthy; premenopausal; postmenarchal; chemotherapy; alkylating agent; alkylator; high dose cancer therapy; low dose cancer therapy