<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03230084</url>
  </required_header>
  <id_info>
    <org_study_id>M16-17-027</org_study_id>
    <nct_id>NCT03230084</nct_id>
  </id_info>
  <brief_title>Use of a Home-based PDG Urine Test to Confirm Ovulation</brief_title>
  <official_title>Use of a Home-based Urinary Pregnanediol 3-glucuronide (PDG) Test to Confirm Ovulation</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Bruyere Research Institute</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Rene Leiva, MD</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Bruyere Foundation</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Bruyere Research Institute</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>Yes</is_fda_regulated_device>
    <is_us_export>Yes</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      Infertility affects many people in Ontario and carries a significant amount of emotional,&#xD;
      physical and financial burden to those who experience it. Knowing when a woman ovulates is&#xD;
      important for improving a couple's chance to become pregnant naturally and for learning about&#xD;
      fertility problems, such as infertility, irregular menses, and hormonal disorders.&#xD;
&#xD;
      Currently, there are two reliable methods to confirm ovulation: a trans-vaginal ultrasound or&#xD;
      a blood test for progesterone, which is a hormone that only rises sharply after ovulation.&#xD;
      However, both are time consuming and expensive. Recently, an inexpensive, home-based urine&#xD;
      test strip has been developed to confirm ovulation. The test strip works by measuring urine&#xD;
      for a marker of Progesterone, called pregnanediol-3a-glucuronide (PDG).&#xD;
&#xD;
      The purpose of this feasibility study is to follow the use of this home-based PDG urinary&#xD;
      test strip over the course of one menstrual cycle in 25 female participants. The results of&#xD;
      the urine test strip will then be compared to a Progesterone blood test. Participants will be&#xD;
      recruited from the general Ottawa, Ontario area The ultimate aim of this study is to provide&#xD;
      information for the design of a larger study to determine the accuracy of the PDG urinary&#xD;
      test strip. If shown to be as effective in confirming ovulation, this test would provide&#xD;
      substantial cost saving to the Ontario health care system and a much more convenient way for&#xD;
      women and clinicians to confirm ovulation and determine if women are fertile.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Infertility affects many people in Ontario and carries a significant amount of emotional,&#xD;
      physical and financial burden to those who experience it. More specifically, it impacts the&#xD;
      couple's quality of life and can have detrimental effects related to marital conflicts,&#xD;
      couple burnout and psychological disorders including a lack of confidence and depression.&#xD;
&#xD;
      As part of the standard evaluation of infertility, ovulatory function assessment is a&#xD;
      fundamental step. Confirmation that ovulation has actually occurred can only be determined by&#xD;
      performing a serum Progesterone test or by using the gold standard, serial transvaginal&#xD;
      ultrasound. However, both of these investigations require visits to a physician, specialized&#xD;
      laboratory testing, and in the case of ultrasound are often prohibitive due to its high costs&#xD;
      and logistical demands.&#xD;
&#xD;
      In the female body, levels of Progesterone are low in the first half of the menstrual cycle.&#xD;
      After the ovary releases an egg (ovulation) the corpus luteum produces high levels of&#xD;
      Progesterone. Pregnanediol-3a-glucuronide (PDG) is the major urine metabolite of&#xD;
      Progesterone. An inexpensive, home-based PDG urine test strip to confirm ovulation has&#xD;
      recently been developed. The PDG test measures the presence of PDG in urine, which has been&#xD;
      shown to directly correlate with the presence Progesterone in serum (blood). According to&#xD;
      GLOWM (The Global Library of Women's Medicine) PDG levels in urine typically rise 24-36 hours&#xD;
      after ovulation.&#xD;
&#xD;
      Although there also exists a home-based electronic hormone monitor for measuring urinary PDG,&#xD;
      it is not widely available and is very time-consuming for women. Newer methods to monitor PDG&#xD;
      using a simple urinary test strip that are less time consuming would be a welcome addition to&#xD;
      the evaluation of infertility. Additionally, urinary hormonal tests have been proven to be&#xD;
      easy and useful adjuncts to natural fertility markers.&#xD;
&#xD;
      The primary purpose of this feasibility study is to evaluate the use of the PDG urine test in&#xD;
      a clinical setting to determine its accuracy to confirm ovulation when compared to the serum&#xD;
      Progesterone test. This study will follow the use of the PDG urinary test strip over the&#xD;
      course of one menstrual cycle in 25 female participants. In order to obtain participants,&#xD;
      this study will use a non-probability sample using an initiation to volunteer technique for&#xD;
      women in the general Ottawa area. The ultimate aim of this study is to provide information&#xD;
      for the design of a larger study to determine the accuracy of the PDG urinary test strip.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">August 23, 2017</start_date>
  <completion_date type="Actual">March 14, 2018</completion_date>
  <primary_completion_date type="Actual">March 14, 2018</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Device Feasibility</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Sensitivity and specificity of the PDG urine test strip</measure>
    <time_frame>1 month</time_frame>
    <description>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.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Frequency of protocol violation</measure>
    <time_frame>1 month</time_frame>
    <description>Percentage of participants who violated protocol to show acceptability of study design to participants.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Frequency of positive responses versus negative responses about the study procedures</measure>
    <time_frame>1 month</time_frame>
    <description>Ratio of positive responses to negative responses in the feedback questionnaire given to participants concerning the study protocol.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Frequency of positive responses versus negative responses on the study product</measure>
    <time_frame>1 month</time_frame>
    <description>Ratio of positive responses to negative responses in the feedback questionnaire given to participants concerning the study product.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">25</enrollment>
  <condition>Infertility, Female</condition>
  <arm_group>
    <arm_group_label>Urine PDG test</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Urine pregnanediol 3-glucuronide (PDG) test strip</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Urine PDG test</intervention_name>
    <description>Urine dipstick test that detects the presence of the urinary metabolite of progesterone, PDG.</description>
    <arm_group_label>Urine PDG test</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Females aged 18 to 42 years&#xD;
&#xD;
          -  Have had a menstrual cycle length of 25-35 days for the past 3 months&#xD;
&#xD;
          -  Are able to provide informed consent&#xD;
&#xD;
          -  Are willing to complete a trial diary&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Have current or recent (in the past 6 months) use of any hormonal contraception (e.g.&#xD;
             the Pill, Norplant, Depo Provera injections)&#xD;
&#xD;
          -  Have current or recent (in the past 6 months) breastfeeding&#xD;
&#xD;
          -  Have use of emergency contraception (e.g. the morning after pill or Plan B) in the&#xD;
             past two menstrual cycles&#xD;
&#xD;
          -  Cannot medically receive frequent blood tests, for example due to a blood clotting&#xD;
             disorder&#xD;
&#xD;
          -  Are pregnant at the time of enrollment to study&#xD;
&#xD;
          -  Plan to donate blood during the study&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>42 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Rene Leiva, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Bruyere Research Institute</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Bruyere Research Institute</name>
      <address>
        <city>Ottawa</city>
        <state>Ontario</state>
        <zip>K1N5C7</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Canada</country>
  </location_countries>
  <link>
    <url>http://articles.latimes.com/1993-01-07/news/vw-935_1_birth-controlmethods</url>
    <description>: As couples search for satisfactory forms of contraception, some 'rediscover' a traditional method; others are introduced to birth control by an unconventional messenger.</description>
  </link>
  <link>
    <url>https://www.nice.org.uk/guidance/cg156</url>
    <description>Fertility problems: assessment and treatment</description>
  </link>
  <link>
    <url>http://www.health.gov.on.ca/en/public/programs/ivf/docs/ivf_report.pdf</url>
    <description>Advisory Process for Infertility Services Report: Key Recommendations.</description>
  </link>
  <reference>
    <citation>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.</citation>
    <PMID>23831784</PMID>
  </reference>
  <reference>
    <citation>Messerlian 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.</citation>
    <PMID>24591273</PMID>
  </reference>
  <reference>
    <citation>Brown 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.</citation>
    <PMID>20923873</PMID>
  </reference>
  <reference>
    <citation>Vigil 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.</citation>
    <PMID>16731410</PMID>
  </reference>
  <reference>
    <citation>Bushnik 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. Erratum In: Hum Reprod. 2013 Apr;28(4):1151.</citation>
    <PMID>22258658</PMID>
  </reference>
  <reference>
    <citation>Ghavi 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.</citation>
    <PMID>26573033</PMID>
  </reference>
  <reference>
    <citation>Evans-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.</citation>
    <PMID>23850303</PMID>
  </reference>
  <reference>
    <citation>Robinson 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.</citation>
    <PMID>17074329</PMID>
  </reference>
  <reference>
    <citation>Leiva 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.</citation>
    <PMID>26111590</PMID>
  </reference>
  <reference>
    <citation>Practice 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.</citation>
    <PMID>22698637</PMID>
  </reference>
  <reference>
    <citation>Practice 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.</citation>
    <PMID>23993665</PMID>
  </reference>
  <reference>
    <citation>Stanford 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.</citation>
    <PMID>25772771</PMID>
  </reference>
  <reference>
    <citation>Leiva 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.</citation>
    <PMID>24808123</PMID>
  </reference>
  <reference>
    <citation>Ecochard 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.</citation>
    <PMID>11510707</PMID>
  </reference>
  <reference>
    <citation>Ecochard 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.</citation>
    <PMID>25724738</PMID>
  </reference>
  <reference>
    <citation>Blackwell LF, Vigil P, Alliende ME, Brown S, Festin M, Cooke DG. Monitoring of ovarian activity by measurement of urinary excretion rates using the Ovarian Monitor, Part IV: the relationship of the pregnanediol glucuronide threshold to basal body temperature and cervical mucus as markers for the beginning of the post-ovulatory infertile period. Hum Reprod. 2016 Feb;31(2):445-53. doi: 10.1093/humrep/dev303. Epub 2015 Dec 17.</citation>
    <PMID>26677961</PMID>
  </reference>
  <reference>
    <citation>Sauer MV, Paulson RJ. Utility and predictive value of a rapid measurement of urinary pregnanediol glucuronide by enzyme immunoassay in an infertility practice. Fertil Steril. 1991 Nov;56(5):823-6. doi: 10.1016/s0015-0282(16)54649-4.</citation>
    <PMID>1936313</PMID>
  </reference>
  <reference>
    <citation>Denari JH, Farinati Z, Casas PR, Oliva A. Determination of ovarian function using first morning urine steroid assays. Obstet Gynecol. 1981 Jul;58(1):5-9.</citation>
    <PMID>7195531</PMID>
  </reference>
  <reference>
    <citation>Adlercreutz H, Brown J, Collins W, Goebelsman U, Kellie A, Campbell H, Spieler J, Braissand G. The measurement of urinary steroid glucuronides as indices of the fertile period in women. World Health Organization, Task Force on Methods for the Determination of the Fertile Period, special programme of research, development and research training in human reproduction. J Steroid Biochem. 1982 Dec;17(6):695-702. doi: 10.1016/0022-4731(82)90573-8.</citation>
    <PMID>7176659</PMID>
  </reference>
  <reference>
    <citation>Sauer MV, Paulson RJ, Chenette P, Frederick J, Stanczyk FZ. Effect of hydration on random levels of urinary pregnanediol glucuronide. Gynecol Endocrinol. 1990 Sep;4(3):145-9. doi: 10.3109/09513599009009801.</citation>
    <PMID>2284979</PMID>
  </reference>
  <reference>
    <citation>Stirnemann JJ, Samson A, Bernard JP, Thalabard JC. Day-specific probabilities of conception in fertile cycles resulting in spontaneous pregnancies. Hum Reprod. 2013 Apr;28(4):1110-6. doi: 10.1093/humrep/des449. Epub 2013 Jan 22.</citation>
    <PMID>23340057</PMID>
  </reference>
  <reference>
    <citation>Wesselink AK, Wise LA, Hatch EE, Rothman KJ, Mikkelsen EM, Stanford JB, McKinnon CJ, Mahalingaiah S. Menstrual cycle characteristics and fecundability in a North American preconception cohort. Ann Epidemiol. 2016 Jul;26(7):482-487.e1. doi: 10.1016/j.annepidem.2016.05.006. Epub 2016 May 31.</citation>
    <PMID>27449569</PMID>
  </reference>
  <reference>
    <citation>Bigelow JL, Dunson DB, Stanford JB, Ecochard R, Gnoth C, Colombo B. Mucus observations in the fertile window: a better predictor of conception than timing of intercourse. Hum Reprod. 2004 Apr;19(4):889-92. doi: 10.1093/humrep/deh173. Epub 2004 Feb 27.</citation>
    <PMID>14990542</PMID>
  </reference>
  <verification_date>July 2017</verification_date>
  <study_first_submitted>July 24, 2017</study_first_submitted>
  <study_first_submitted_qc>July 24, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">July 26, 2017</study_first_posted>
  <last_update_submitted>March 19, 2018</last_update_submitted>
  <last_update_submitted_qc>March 19, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">March 20, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Infertility</keyword>
  <keyword>Ovulation</keyword>
  <keyword>Pregnanediol 3-glucuronide</keyword>
  <keyword>Progesterone</keyword>
  <keyword>Urine dipstick test</keyword>
  <keyword>Feasibility study</keyword>
  <keyword>Fertile period</keyword>
  <keyword>Menstrual cycle</keyword>
  <keyword>Natural family planning</keyword>
  <keyword>Fertility awareness methods</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Infertility</mesh_term>
    <mesh_term>Infertility, Female</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03230084
org study id: M16-17-027
nct id: NCT03230084
lead sponsor: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: Yes
is us export: Yes
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.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Device Feasibility
masking: None (Open Label)
measure: Sensitivity and specificity of the PDG urine test strip
time frame: 1 month
description: 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.
measure: Frequency of protocol violation
time frame: 1 month
description: Percentage of participants who violated protocol to show acceptability of study design to participants.
measure: Frequency of positive responses versus negative responses about the study procedures
time frame: 1 month
description: Ratio of positive responses to negative responses in the feedback questionnaire given to participants concerning the study protocol.
measure: Frequency of positive responses versus negative responses on the study product
time frame: 1 month
description: Ratio of positive responses to negative responses in the feedback questionnaire given to participants concerning the study product.
arm group label: Urine PDG test
arm group type: Experimental
description: Urine pregnanediol 3-glucuronide (PDG) test strip
intervention type: Device
intervention name: Urine PDG test
description: Urine dipstick test that detects the presence of the urinary metabolite of progesterone, PDG.
arm group label: Urine PDG test
criteria: 
gender: Female
minimum age: 18 Years
maximum age: 42 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Rene Leiva, MD
role: Principal Investigator
affiliation: Bruyere Research Institute
facility: 
country: Canada
url: http://articles.latimes.com/1993-01-07/news/vw-935_1_birth-controlmethods
description: : As couples search for satisfactory forms of contraception, some 'rediscover' a traditional method; others are introduced to birth control by an unconventional messenger.
url: https://www.nice.org.uk/guidance/cg156
description: Fertility problems: assessment and treatment
url: http://www.health.gov.on.ca/en/public/programs/ivf/docs/ivf_report.pdf
description: Advisory Process for Infertility Services Report: Key Recommendations.
citation: 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.
PMID: 23831784
citation: Messerlian 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.
PMID: 24591273
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responsible party type: Sponsor
mesh term: Infertility
mesh term: Infertility, Female
sharing ipd: No