Fertility in Healthy Premenopausal Women

Status Completed

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

Fertility

Clinical Trial Details

NCT number	NCT02772848
Study type	Observational
Source	Fujirebio Diagnostics, Inc.
Contact
Status	Completed
Phase	N/A
Start date	April 2016
Completion date	July 2016

View Details

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