Infertility, FemaleNCT03230084
Use of a Home-based PDG Urine Test to Confirm Ovulation
A study testing Urine PDG test in people with Infertility, Female, run by Bruyère Health Research Institute. at 1 site in Canada.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 42 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Infertility, Female
- What is being tested?
- Urine PDG test
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteCanada
- Study dates
- 23 Aug 2017to 14 Mar 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 42 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Infertility, Female
- Being tested
- Urine PDG test
- Keywords
- Infertility, Ovulation, Pregnanediol 3-glucuronide, Progesterone, Urine dipstick test, Feasibility study, Fertile period, Menstrual cycle, Natural family planning, Fertility awareness methods
- Medical subject headings
- Infertility, Female, Infertility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Urine PDG testDevice
Urine dipstick test that detects the presence of the urinary metabolite of progesterone, PDG.
| Study group | Role | What they receive |
|---|---|---|
| Urine PDG test | Experimental | Urine pregnanediol 3-glucuronide (PDG) test strip Receives: Device: Urine PDG test |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 month
Secondary outcomes (3)
Frequency of protocol violation
Percentage of participants who violated protocol to show acceptability of study design to participants.
Measured: 1 month
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.
Measured: 1 month
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.
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jul 2017
- Study start23 Aug 2017
- Primary completion14 Mar 2018
- Study completion14 Mar 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (24)Papers the sponsor has linked to this study.
- Other trials for Infertility, FemaleStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bruyère Health Research Institute.
- Sponsor type
- University, hospital or other
- Collaborators
- Rene Leiva, MD, Bruyere Foundation
- Responsible party
- Sponsor
- Investigators
- Rene Leiva, MD, Principal investigator, Bruyère Health Research Institute.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03230084
- Sponsor's protocol ID
- M16-17-027
- Status last verified
- Jul 2017
- First submitted
- 24 Jul 2017
- Last updated
- 20 Mar 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Ecochard R, Leiva R, Bouchard T, Boehringer H, Direito A, Mariani A, Fehring R. Use of urinary pregnanediol 3-glucuronide to confirm ovulation. Steroids. 2013 Oct;78(10):1035-40. doi: 10.1016/j.steroids.2013.06.006. Epub 2013 Jul 4.
PubMed 23831784Messerlian C, Fishman JR. Less is more: improving outcomes and cutting costs to Quebec's assisted reproduction program. CMAJ. 2014 Apr 1;186(6):405-6. doi: 10.1503/cmaj.131672. Epub 2014 Mar 3. No abstract available.
PubMed 24591273Brown JB. Types of ovarian activity in women and their significance: the continuum (a reinterpretation of early findings). Hum Reprod Update. 2011 Mar-Apr;17(2):141-58. doi: 10.1093/humupd/dmq040. Epub 2010 Oct 5.
PubMed 20923873Vigil P, Ceric F, Cortes ME, Klaus H. Usefulness of monitoring fertility from menarche. J Pediatr Adolesc Gynecol. 2006 Jun;19(3):173-9. doi: 10.1016/j.jpag.2006.02.003.
PubMed 16731410Bushnik T, Cook JL, Yuzpe AA, Tough S, Collins J. Estimating the prevalence of infertility in Canada. Hum Reprod. 2012 Mar;27(3):738-46. doi: 10.1093/humrep/der465. Epub 2012 Jan 17.
PubMed 22258658Ghavi F, Jamale S, Mosalanejad L, Mosallanezhad Z. A Study of Couple Burnout in Infertile Couples. Glob J Health Sci. 2015 Aug 6;8(4):158-65. doi: 10.5539/gjhs.v8n4p158.
PubMed 26573033Evans-Hoeker E, Pritchard DA, Long DL, Herring AH, Stanford JB, Steiner AZ. Cervical mucus monitoring prevalence and associated fecundability in women trying to conceive. Fertil Steril. 2013 Oct;100(4):1033-1038.e1. doi: 10.1016/j.fertnstert.2013.06.002. Epub 2013 Jul 11.
PubMed 23850303Robinson JE, Wakelin M, Ellis JE. Increased pregnancy rate with use of the Clearblue Easy Fertility Monitor. Fertil Steril. 2007 Feb;87(2):329-34. doi: 10.1016/j.fertnstert.2006.05.054. Epub 2006 Oct 30.
PubMed 17074329Leiva R, Bouchard T, Boehringer H, Abulla S, Ecochard R. Random serum progesterone threshold to confirm ovulation. Steroids. 2015 Sep;101:125-9. doi: 10.1016/j.steroids.2015.06.013. Epub 2015 Jun 22.
PubMed 26111590Practice Committee of American Society for Reproductive Medicine. Diagnostic evaluation of the infertile female: a committee opinion. Fertil Steril. 2012 Aug;98(2):302-7. doi: 10.1016/j.fertnstert.2012.05.032. Epub 2012 Jun 13.
PubMed 22698637Practice Committee of American Society for Reproductive Medicine in collaboration with Society for Reproductive Endocrinology and Infertility. Optimizing natural fertility: a committee opinion. Fertil Steril. 2013 Sep;100(3):631-7. doi: 10.1016/j.fertnstert.2013.07.011.
PubMed 23993665Stanford JB. Revisiting the fertile window. Fertil Steril. 2015 May;103(5):1152-3. doi: 10.1016/j.fertnstert.2015.02.015. Epub 2015 Mar 13. No abstract available.
PubMed 25772771Leiva R, Burhan U, Kyrillos E, Fehring R, McLaren R, Dalzell C, Tanguay E. Use of ovulation predictor kits as adjuncts when using fertility awareness methods (FAMs): a pilot study. J Am Board Fam Med. 2014 May-Jun;27(3):427-9. doi: 10.3122/jabfm.2014.03.130255.
PubMed 24808123Ecochard R, Boehringer H, Rabilloud M, Marret H. Chronological aspects of ultrasonic, hormonal, and other indirect indices of ovulation. BJOG. 2001 Aug;108(8):822-9. doi: 10.1111/j.1471-0528.2001.00194.x.
PubMed 11510707Ecochard R, Duterque O, Leiva R, Bouchard T, Vigil P. Self-identification of the clinical fertile window and the ovulation period. Fertil Steril. 2015 May;103(5):1319-25.e3. doi: 10.1016/j.fertnstert.2015.01.031. Epub 2015 Feb 24.
PubMed 25724738
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of a Home-based Urinary Pregnanediol 3-glucuronide (PDG) Test to Confirm Ovulation
- ClinicalTrials.gov ID
- NCT03230084
- Acronym / sponsor ID
- M16-17-027
- Conditions
- Infertility, Female
- Keywords
- Infertility, Ovulation, Pregnanediol 3-glucuronide, Progesterone, Urine dipstick test, Feasibility study, Fertile period, Menstrual cycle
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Bruyère Health Research Institute.University, hospital or other
- Collaborators
- Rene Leiva, MD, Bruyere Foundation
- Study start
- 23 Aug 2017 (actual)
- Primary completion
- 14 Mar 2018 (actual)
- Study completion
- 14 Mar 2018 (actual)
- First posted
- 26 Jul 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Urine PDG test | Experimental | Device: Urine PDG testUrine pregnanediol 3-glucuronide (PDG) test strip |
Who may qualify
- Ages
- 18 to 42 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Urine PDG testUrine dipstick test that detects the presence of the urinary metabolite of progesterone, PDG. | Device | Urine PDG test |
Primary outcome
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.
3 secondary outcomes
Frequency of protocol violation
Time frame: 1 month
Frequency of positive responses versus negative responses about the study procedures
Time frame: 1 month
Frequency of positive responses versus negative responses on the study product
Time frame: 1 month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Mar 2018.
- Background: PubMed 23831784Ecochard R, Leiva R, Bouchard T, Boehringer H, Direito A, Mariani A, Fehring R. Use of urinary pregnanediol 3-glucuronide to confirm ovulation. Steroids. 2013 Oct;78(10):1035-40. doi: 10.1016/j.steroids.2013.06.006. Epub 2013 Jul 4.
- Background: PubMed 24591273Messerlian C, Fishman JR. Less is more: improving outcomes and cutting costs to Quebec's assisted reproduction program. CMAJ. 2014 Apr 1;186(6):405-6. doi: 10.1503/cmaj.131672. Epub 2014 Mar 3. No abstract available.
- Background: PubMed 20923873Brown JB. Types of ovarian activity in women and their significance: the continuum (a reinterpretation of early findings). Hum Reprod Update. 2011 Mar-Apr;17(2):141-58. doi: 10.1093/humupd/dmq040. Epub 2010 Oct 5.
- Background: PubMed 16731410Vigil P, Ceric F, Cortes ME, Klaus H. Usefulness of monitoring fertility from menarche. J Pediatr Adolesc Gynecol. 2006 Jun;19(3):173-9. doi: 10.1016/j.jpag.2006.02.003.
- Background: PubMed 22258658Bushnik T, Cook JL, Yuzpe AA, Tough S, Collins J. Estimating the prevalence of infertility in Canada. Hum Reprod. 2012 Mar;27(3):738-46. doi: 10.1093/humrep/der465. Epub 2012 Jan 17.
- Background: PubMed 26573033Ghavi F, Jamale S, Mosalanejad L, Mosallanezhad Z. A Study of Couple Burnout in Infertile Couples. Glob J Health Sci. 2015 Aug 6;8(4):158-65. doi: 10.5539/gjhs.v8n4p158.
- Background: PubMed 23850303Evans-Hoeker E, Pritchard DA, Long DL, Herring AH, Stanford JB, Steiner AZ. Cervical mucus monitoring prevalence and associated fecundability in women trying to conceive. Fertil Steril. 2013 Oct;100(4):1033-1038.e1. doi: 10.1016/j.fertnstert.2013.06.002. Epub 2013 Jul 11.
- Background: PubMed 17074329Robinson JE, Wakelin M, Ellis JE. Increased pregnancy rate with use of the Clearblue Easy Fertility Monitor. Fertil Steril. 2007 Feb;87(2):329-34. doi: 10.1016/j.fertnstert.2006.05.054. Epub 2006 Oct 30.
- Background: PubMed 26111590Leiva R, Bouchard T, Boehringer H, Abulla S, Ecochard R. Random serum progesterone threshold to confirm ovulation. Steroids. 2015 Sep;101:125-9. doi: 10.1016/j.steroids.2015.06.013. Epub 2015 Jun 22.
- Background: PubMed 22698637Practice Committee of American Society for Reproductive Medicine. Diagnostic evaluation of the infertile female: a committee opinion. Fertil Steril. 2012 Aug;98(2):302-7. doi: 10.1016/j.fertnstert.2012.05.032. Epub 2012 Jun 13.
- Background: PubMed 23993665Practice Committee of American Society for Reproductive Medicine in collaboration with Society for Reproductive Endocrinology and Infertility. Optimizing natural fertility: a committee opinion. Fertil Steril. 2013 Sep;100(3):631-7. doi: 10.1016/j.fertnstert.2013.07.011.
- Background: PubMed 25772771Stanford JB. Revisiting the fertile window. Fertil Steril. 2015 May;103(5):1152-3. doi: 10.1016/j.fertnstert.2015.02.015. Epub 2015 Mar 13. No abstract available.
- : As couples search for satisfactory forms of contraception, some 'rediscover' a traditional method; others are introduced to birth control by an unconventional messenger.Link provided by the sponsor.
- Schedule of Benefits Physician Services Under the Health Insurance Act.Link provided by the sponsor.
- Fertility problems: assessment and treatmentLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rene Leiva, MD principal investigator
Bruyère Health Research Institute.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Urine PDG test in people with Infertility, Female, run by Bruyère Health Research Institute. at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Mar 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sensitivity and specificity of the PDG urine test strip (time frame: 1 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03230084, which also lists 24 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Mar 2018.