CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 25 enrolled
Drug / intervention
Urine PDG testdevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03230084
NCT03230084N/ACompleted

Use of a Home-based Urinary Pregnanediol 3-glucuronide (PDG) Test to Confirm Ovulation

Bruyère Health Research Institute.·interventional·Posted Jul 26, 2017·Updated Mar 20, 2018

In Brief

A clinical study evaluating Urine PDG test for Infertility, Female. Completed, enrolled 25 participants across 1 site.

Detailed Summary

Infertility affects many people in Ontario and carries a significant amount of emotional, physical and financial burden to those who experience it. Knowing when a woman ovulates is important for improving a couple's chance to become pregnant naturally and for learning about fertility problems, such as infertility, irregular menses, and hormonal disorders. Currently, there are two reliable methods to confirm ovulation: a trans-vaginal ultrasound or a blood test for progesterone, which is a hormone that only rises sharply after ovulation. However, both are time consuming and expensive. Recently, an inexpensive, home-based urine test strip has been developed to confirm ovulation. The test strip works by measuring urine for a marker of Progesterone, called pregnanediol-3a-glucuronide (PDG). The purpose of this feasibility study is to follow the use of this home-based PDG urinary test strip over the course of one menstrual cycle in 25 female participants. The results of the urine test strip will then be compared to a Progesterone blood test. Participants will be recruited from the general Ottawa, Ontario area The ultimate aim of this study is to provide information for the design of a larger study to determine the accuracy of the PDG urinary test strip. If shown to be as effective in confirming ovulation, this test would provide substantial cost saving to the Ontario health care system and a much more convenient way for women and clinicians to confirm ovulation and determine if women are fertile.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesCanada

Timeline

N/ACompletedFinished
201820192020202120222023202420252026
First PostedJul 26, 2017
Enrollment StartAug 23, 2017
Primary CompletionMar 14, 2018
TodayJul 2, 2026
Enrollment to primary: 7 monthsPosted 8.9 years ago

Interventions

Urine PDG testdevice

Urine dipstick test that detects the presence of the urinary metabolite of progesterone, PDG.