NCT02772848

Fertility in Healthy Premenopausal Women

A Prospective Collection of Peripheral Blood Specimens to Study Fertility in Healthy, Premenopausal Women

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 60 (actual)
• Sponsor: Fujirebio Diagnostics, Inc. · Industry
• Sex: Female
• Age: 21 Years
• Healthy volunteers: Accepted

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.

Detailed 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.

Conditions

• Fertility

Timeline

• Start date: 2016-04-01
• Primary completion: 2016-07-01
• Completion: 2016-07-01
• First posted: 2016-05-16
• Last updated: 2016-08-10

Locations

2 sites across 1 country: United States