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About
The study objectives are described below:
Full description
The purpose of this study is to obtain sufficient specimens and correlating clinical data from a well-controlled prospective clinical trial collecting specimens from healthy, premenopausal subjects to support domestic and international regulatory submissions on fertility biomarker assays, and to establish a collection of specimens that will support future assay discovery and validation efforts.
Enrollment
Sex
Ages
Volunteers
Inclusion criteria
Exclusion criteria
Males
Females, age <21 years
Weighing < 110 lbs
Anemic (Hemoglobin < 12.5 g/dL)
History of bilateral oophorectomy
Females taking any form of hormonal birth control including:
Women in menopause (defined as the end of menstrual cycles or at least more than 365 days since the last menstrual cycle)
Amenorrhea except for women that continue to ovulate as documented in a physician note available to the enrolling center.
Has a current diagnosis of any clinically significant cardiac, respiratory, neurological, immunological, hematological, liver disease, renal disease, gastrointestinal (GI) disorder, including any history of hyper- or hypothyroid, peptic or gastric ulcers or GI bleeding, or any other condition which, in the opinion of the investigator, would deem the subject unhealthy and therefore, ineligible.
Has a history of any clinically significant cardiac, respiratory, neurological, immunological, hematological, liver disease, renal disease, gastrointestinal (GI) disorder, including any history of hyper- or hypothyroid, peptic or gastric ulcers or GI bleeding, or any other condition which, in the opinion of the investigator, is unstable at the time of enrollment.
Is receiving systemic chemotherapy or radiation treatment, has an active malignancy of any type, or has been diagnosed with cancer within 5 years before screening other than basal or squamous cell skin cancers or in-situ cervical cancer.
History of seizures
Diagnosed with an infectious disease including any sexually transmitted diseases.
Diagnosed with HIV/AIDS or ever tested positive for HIV.
History of hepatitis
Subject that has had sexual contact with a person who has hepatitis within the last 12 months.
Pregnancy, lactation or actively seeking to conceive (trying to become pregnant).
Unable to provide informed consent.
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Data sourced from clinicaltrials.gov
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