Executive Summary for the Pregnanediol-3a-Glucuronide Fertility

study
Principal Investigator: Dr. Rene Leiva

Background
Approximately one in six couples in Ontario have experienced infertility at some point in their lives.
Infertility can cause extreme emotional, physical and financial burden to those who experience it.
However, forty percent of couples who seek infertility services conceive without treatment. To improve a
couples chance for conceiving naturally, it is necessary to confirm when ovulation occurs.
Confirmation that ovulation has occurred can only be done by performing a blood test for serum
progesterone test or by serial transvaginal ultrasound. However, both of these investigations require visits
to a physician, specialized laboratory testing, and in the case of ultrasound high costs and logistical
demands. For example, excluding the costs of the doctors visit, the 2015 cost of a transvaginal
ultrasound procedure in the province of Ontario is approx. $250 and the cost of a serum progesterone
blood test is approximately $20.
A simple home-based pregnanediol-3a-glucuronide (PdG) urinary test to confirm ovulation has been
developed (https://www.mfbfertility.com/) but is not yet approved for use in Canada. The PdG urinary test
works by measuring urine for a marker of Progesterone, which is a hormone that rises sharply only after
ovulation. 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 fertility.
Purpose and Study Design
This pilot study will be the first clinical evaluation of the home based PdG urinary test strip and will
evaluate feasibility and usability of the PdG urinary test strip over the course of one menstrual cycle in 20
female participants in the general Ottawa area. Both English and French-speaking participants will be
recruited through an advertising campaign aimed at Family Health Clinics and Infertility Groups. 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.
Each participant in the study will be provided with PdG urine test strips for daily testing at home. During
the study, participants will have blood drawn to check for a rise in serum Progesterone. In order to see if
the PdG urine test strip can confirm ovulation, the results of this test will be compared to the blood test.
PdG Urine Test Strip
The PdG urine test strip will be bought and imported from the manufacturer, MFB Fertility, Inc., Boulder,
Colorado, USA. This study device is considered investigational and therefore has not been approved for
sale or use by Health Canada. An application to Health Canada has been submitted by the Principal
Investigator for approval for the use of the PdG urine test strip in this research study. Approval is pending.
Study Setting and Study Team
This feasibility study will be conducted under the leadership of Dr. Rene Leiva, MD and supported by the
Clinical Trials Group at the Bruyre Research Institute (BRI). The Clinical Trials Group supports clinical trials
and clinical research in the areas of brain and mind, nutrition, aging, primary health and dermatology. The
study will also receive methodological support from the C.T. Lamont Primary Health Care Research Centre
(CTLC), a Centre within the BRI and the research arm of the Department of Family Medicine at the
University of Ottawa. The CTLC has a team of 13 skilled researchers that offers mentorship to faculty
members and residents and staff that provides support and training.
Each member of the research team is qualified by education, training and experience to perform his or her
respective tasks, and is approved by the principal investigator. Before study start, approval will be sought
from the Bruyre Continuing Care Research Ethical Board.
Future Implications
Confirmation of ovulation is an essential step in the assessment of ovulatory function during the work up of
every infertile couple. Currently, this assessment requires visits to the doctor and specialized tests such as
endocrine blood tests and ultrasound exams. However, if this point-of-care PdG urine test were to be
effective, this process would be greatly simplified resulting in potential reduced cost to the health care
system, expediting information available to the clinician in the initial stages of the fertility evaluation and
empowering women by giving them the ability to monitor their own ovulation. The PdG urine test would
be analogous to the benefit that home urine pregnancy tests brought to the assessment whenever an
early pregnancy is suspected.

2017-2018 Funding Request: $15,000.00

Pregnanediol-3a-Glucuronide Fertility Study - Principal Investigator: Dr. Rene
Leiva

BUDGET Request In-Kind Total

Personnel
Clinical Trials Research Coordinator $6260.25 $3645.7 $9906.00
$30/hr. +27% benefits = $38.10 /hr. x 5 hrs. per week x 5
52 weeks = 260 hrs.
Research Assistant $25/hr. + 27% benefits = $31.75 x $952.50 $952.50
30 hrs.
Statistician: $70/hr (inclusive of HST) x 20hrs. $1,400.0 $1,400.0
0 0
Total Personnel $8612.75 $3645.7 $12,258.
5 50
Materials and Supplies
Urine Pregnancy Test package of 50 tests for $35.45 $35.45 $35.45
through Amazon.ca. Shipping free.
Urine LH strips - 20 participants x 40 strips (Day 7-39 of $542.40 $542.40
one cycle)/participant = 800 strips x $0.60 (inclusive
of HST)/strip
Urinary PDG strips - 20 participants x 40 strips (Day 7- $2533.80 $2533.80
39 of one cycle) /participant = 800 strips needed.
Manufacturer will provide 800 strips for $3.00CDN/strip
=
Shipping from the US to Canada $100.00 US ($ 133.80
CDN).
Serum Progesterone tests - 20 participants x 4 tests $1869.60 $1869.60
(one cycle/participant = 80 tests x $23.37 (inclusive of
HST)/test. Testing includes phlebotomy and processing.
Promotional Material : Printing 100 colour copies 8 x11 $40.00 $40.00
inch recruitment fliers at Staples = $0.40 (inclusive of
HST) /flier x 250
Stamps to mail out recruitment fliers. ($.90stamp/flier $90.00 $90.00
x 100 fliers)
Translation of Recruitment Flier and the Participant $100.00 $100.00
Diaries (estimate of word count = 500 words x
$.20/word)
Printing of 33 +7 (extra) participant colour diaries = $16.00 $16.00
$0.40 (inclusive of HST)/diary x 40
Total Materials and Supplies $5227.25 $5227.25
Other Expenses
Participant parking reimbursement for visits to the $600.00 $600.00
Clinical Trials Unit - Bruyre Research Institute (75
Bruyre St, Ottawa, ON) - 20 participants x 2
visits/participant x $15.00 (inclusive of HST)/visit.
Participant parking reimbursement for LifeLabs at the $560.00 $560.00
Riverside Hospital, Ottawa ON Monday Friday (0.5hr.-
1.0hr = $7.00) 20 participant x $7.00 parking fee
(inclusive of HST) x 4 visits /participant)
Total Other Expenses $1160.00 $1160.00
Total Funding Request $15,000.
00
Total In-kind Support $3645.7
5
Total Project Costs (Funding Request + In-kind $18,645.
Support) 75