Use of a Home-based PDG Urine Test to Confirm Ovulation
Condition: Infertility, Female
MeSH terms: Infertility; Infertility, Female
Study type: Interventional

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.
    

Intervention name(s): Urine PDG test
Intervention type(s): Device
Intervention description(s): Urine dipstick test that detects the presence of the urinary metabolite of progesterone, PDG.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Device Feasibility
Keywords: Infertility; Ovulation; Pregnanediol 3-glucuronide; Progesterone; Urine dipstick test; Feasibility study; Fertile period; Menstrual cycle; Natural family planning; Fertility awareness methods