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Use of a Home-based PDG Urine Test to Confirm Ovulation

NCT03230084 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 25

Last updated 2018-03-20

No results posted yet for this study

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.

Conditions

  • Infertility, Female

Interventions

DEVICE

Urine PDG test

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

Sponsors & Collaborators

  • Rene Leiva, MD

    collaborator UNKNOWN

  • Bruyere Foundation

    collaborator UNKNOWN

  • Bruyère Health Research Institute.

    lead OTHER

Principal Investigators

  • Rene Leiva, MD · Bruyère Health Research Institute.

Study Design

Allocation
NA
Purpose
DEVICE_FEASIBILITY
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
42 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2017-08-23
Primary Completion
2018-03-14
Completion
2018-03-14
FDA Device
Yes

Countries

  • Canada

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03230084 on ClinicalTrials.gov