Infertility, Female Clinical Trial
Official title:
Use of a Home-based Urinary Pregnanediol 3-glucuronide (PDG) Test to Confirm Ovulation
Verified date | July 2017 |
Source | Bruyere Research Institute |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 25 |
Est. completion date | March 14, 2018 |
Est. primary completion date | March 14, 2018 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | 18 Years to 42 Years |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
Canada | Bruyere Research Institute | Ottawa | Ontario |
Lead Sponsor | Collaborator |
---|---|
Bruyere Research Institute | Bruyere Foundation, Rene Leiva, MD |
Canada,
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* Note: There are 23 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Sensitivity and specificity of the PDG urine test strip | 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. | 1 month | |
Secondary | Frequency of protocol violation | Percentage of participants who violated protocol to show acceptability of study design to participants. | 1 month | |
Secondary | Frequency of positive responses versus negative responses about the study procedures | Ratio of positive responses to negative responses in the feedback questionnaire given to participants concerning the study protocol. | 1 month | |
Secondary | Frequency of positive responses versus negative responses on the study product | Ratio of positive responses to negative responses in the feedback questionnaire given to participants concerning the study product. | 1 month |
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