Infertility, Female Clinical Trial
Official title:
Use of a Home-based Urinary Pregnanediol 3-glucuronide (PDG) Test to Confirm Ovulation
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.
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.
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