Fertility in Healthy Premenopausal Women
NCT02772848 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 60
Last updated 2016-08-10
Summary
The study objectives are described below:
1. Obtain serum specimens collected for one ovulatory cycle or a maximum of 33 days, but not to exceed a total of 550 ml of whole blood per subject from a minimum of 60 healthy, premenopausal subjects. Specimens will be used to determine a reference range for estradiol, FSH, LH, and progesterone assays, used as an aid in the assessment of fertility in adult, premenopausal women.
2. To store any remaining specimens for use in future assay development and to evaluate as yet undetermined assays for the development of IVDs, including additional estradiol, FSH, LH, and progesterone assays.
Conditions
Sponsors & Collaborators
-
Fujirebio Diagnostics, Inc.
lead INDUSTRY
Principal Investigators
-
Diana Dickson · Fujirebio Diagnostics, Inc.
Eligibility
- Min Age
- 21 Years
- Sex
- FEMALE
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2016-04-30
- Primary Completion
- 2016-07-31
- Completion
- 2016-07-31
Countries
- United States
Study Locations
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