Fertility in Healthy Premenopausal Women

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.

Inclusion criteria

• Females, age ≥ 21 years
• Premenopausal (defined as a woman that has had at least one menstrual cycle in the last 365 days).
• A minimum weight of 110 lbs
• The subject is not anemic (Hemoglobin ≥ 12.5 g/dL)
• Willing to provide a daily blood draw for one ovulatory cycle or a maximum of 33 days
• Able to understand and willing to provide informed consent.

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:

• Oral contraceptive pill (combined or progestin-only) within five days enrollment.
• Contraceptive patch (such as Ortho Evra®) within seven days of enrollment.
• Vaginal contraceptive ring (such as NuvaRing™) within 21 days of enrollment.
• Contraceptive injection (such as Depo-Provera®) within 90 days of enrollment.
• Intra-uterine system (IUS) within 90 days of enrollment. An intra-uterine device (IUD) made of copper does not exclude the patient from participating in this study.
• Subdermal contraceptive implants (such as Nexplanon®) within 90 days of enrollment.
• Emergency contraceptive within 30 days of enrollment.
• 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.