Use of a Home-based PDG Urine Test to Confirm Ovulation

Infertility, Female Clinical Trial

Official title:

Use of a Home-based Urinary Pregnanediol 3-glucuronide (PDG) Test to Confirm Ovulation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03230084
• Other study ID #: M16-17-027
• Status: Completed
• Phase: N/A
• First received: July 24, 2017
• Last updated: March 19, 2018
• Start date: August 23, 2017
• Est. completion date: March 14, 2018

Study information

• Verified date: July 2017
• Source: Bruyere Research Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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, 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.

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.

Recruitment information / eligibility

• 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

Related Conditions & MeSH terms

• Infertility
• Infertility, Female

Intervention

Device:
• Urine PDG test
Urine dipstick test that detects the presence of the urinary metabolite of progesterone, PDG.

Locations

Country	Name	City	State
Canada	Bruyere Research Institute	Ottawa	Ontario

Sponsors (3)

Lead Sponsor	Collaborator
Bruyere Research Institute	Bruyere Foundation, Rene Leiva, MD

Country where clinical trial is conducted

Canada, 

References & Publications (23)

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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. Epub 2004 Feb 27. — View 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. — View 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. Review. — View Citation

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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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. Epub 2012 Jun 13. — View 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. Epub 2006 Oct 30. — View 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. — View 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. — View 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. — View 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. — View Citation

Vigil P, Ceric F, Cortés ME, Klaus H. Usefulness of monitoring fertility from menarche. J Pediatr Adolesc Gynecol. 2006 Jun;19(3):173-9. — View 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. — View Citation

* Note: There are 23 references in all — Click here to view all references

Outcome

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

External Links

•   : As couples search for satisfactory forms of contraception, some 'rediscover' a traditional method; others are introduced to birth control by an unconventional messenger.
•   Advisory Process for Infertility Services Report: Key Recommendations.
•   Fertility problems: assessment and treatment
•   Schedule of Benefits Physician Services Under the Health Insurance Act.