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

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ClinicalTrials.gov Identifier: NCT03230084
Recruitment Status : Completed
First Posted : July 26, 2017
Last Update Posted : March 20, 2018
Sponsor:
Collaborators:
Rene Leiva, MD
Bruyere Foundation
Information provided by (Responsible Party):
Bruyere Research Institute

Tracking Information
First Submitted Date  ICMJE July 24, 2017
First Posted Date  ICMJE July 26, 2017
Last Update Posted Date March 20, 2018
Actual Study Start Date  ICMJE August 23, 2017
Actual Primary Completion Date March 14, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 24, 2017)
Sensitivity and specificity of the PDG urine test strip [ Time Frame: 1 month ]
The sensitivity will be estimated as the proportion of true positives cycles, that is, cycles with appropriate recognition of the post-ovulatory phase. The specificity will be estimated as the proportion of true negatives cycles, that is, cycles with appropriate recognition of the pre-ovulatory phase.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 24, 2017)
  • Frequency of protocol violation [ Time Frame: 1 month ]
    Percentage of participants who violated protocol to show acceptability of study design to participants.
  • Frequency of positive responses versus negative responses about the study procedures [ Time Frame: 1 month ]
    Ratio of positive responses to negative responses in the feedback questionnaire given to participants concerning the study protocol.
  • Frequency of positive responses versus negative responses on the study product [ Time Frame: 1 month ]
    Ratio of positive responses to negative responses in the feedback questionnaire given to participants concerning the study product.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Use of a Home-based PDG Urine Test to Confirm Ovulation
Official Title  ICMJE Use of a Home-based Urinary Pregnanediol 3-glucuronide (PDG) Test to Confirm Ovulation
Brief 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.

Detailed Description

Infertility affects many people in Ontario and carries a significant amount of emotional, physical and financial burden to those who experience it. More specifically, it impacts the couple's quality of life and can have detrimental effects related to marital conflicts, couple burnout and psychological disorders including a lack of confidence and depression.

As part of the standard evaluation of infertility, ovulatory function assessment is a fundamental step. Confirmation that ovulation has actually occurred can only be determined by performing a serum Progesterone test or by using the gold standard, serial transvaginal ultrasound. However, both of these investigations require visits to a physician, specialized laboratory testing, and in the case of ultrasound are often prohibitive due to its high costs and logistical demands.

In the female body, levels of Progesterone are low in the first half of the menstrual cycle. After the ovary releases an egg (ovulation) the corpus luteum produces high levels of Progesterone. Pregnanediol-3a-glucuronide (PDG) is the major urine metabolite of Progesterone. An inexpensive, home-based PDG urine test strip to confirm ovulation has recently been developed. The PDG test measures the presence of PDG in urine, which has been shown to directly correlate with the presence Progesterone in serum (blood). According to GLOWM (The Global Library of Women's Medicine) PDG levels in urine typically rise 24-36 hours after ovulation.

Although there also exists a home-based electronic hormone monitor for measuring urinary PDG, it is not widely available and is very time-consuming for women. Newer methods to monitor PDG using a simple urinary test strip that are less time consuming would be a welcome addition to the evaluation of infertility. Additionally, urinary hormonal tests have been proven to be easy and useful adjuncts to natural fertility markers.

The primary purpose of this feasibility study is to evaluate the use of the PDG urine test in a clinical setting to determine its accuracy to confirm ovulation when compared to the serum Progesterone test. This study will follow the use of the PDG urinary test strip over the course of one menstrual cycle in 25 female participants. In order to obtain participants, this study will use a non-probability sample using an initiation to volunteer technique for women in the general Ottawa 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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Device Feasibility
Condition  ICMJE Infertility, Female
Intervention  ICMJE Device: Urine PDG test
Urine dipstick test that detects the presence of the urinary metabolite of progesterone, PDG.
Study Arms  ICMJE Experimental: Urine PDG test
Urine pregnanediol 3-glucuronide (PDG) test strip
Intervention: Device: Urine PDG test
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: July 24, 2017)
25
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE March 14, 2018
Actual Primary Completion Date March 14, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Females aged 18 to 42 years
  • Have had a menstrual cycle length of 25-35 days for the past 3 months
  • Are able to provide informed consent
  • Are willing to complete a trial diary

Exclusion Criteria:

  • Have current or recent (in the past 6 months) use of any hormonal contraception (e.g. the Pill, Norplant, Depo Provera injections)
  • Have current or recent (in the past 6 months) breastfeeding
  • Have use of emergency contraception (e.g. the morning after pill or Plan B) in the past two menstrual cycles
  • Cannot medically receive frequent blood tests, for example due to a blood clotting disorder
  • Are pregnant at the time of enrollment to study
  • Plan to donate blood during the study
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years to 42 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03230084
Other Study ID Numbers  ICMJE M16-17-027
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Product Manufactured in and Exported from the U.S.: Yes
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Bruyere Research Institute
Study Sponsor  ICMJE Bruyere Research Institute
Collaborators  ICMJE
  • Rene Leiva, MD
  • Bruyere Foundation
Investigators  ICMJE
Principal Investigator: Rene Leiva, MD Bruyere Research Institute
PRS Account Bruyere Research Institute
Verification Date July 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP