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Pilot observational prospective cohort study on the use of a novel home-based urinary pregnanediol 3-glucuronide (PDG) test to confirm ovulation when used as adjunct to fertility awareness methods (FAMs) stage 1
  1. Rene Leiva1,2,
  2. Marie McNamara-Kilian2,
  3. Helen Niezgoda2,
  4. René Ecochard3,
  5. Thomas Bouchard4
  1. 1 Department of Family Medicine, University of Ottawa, Ottawa, Ontario, Canada
  2. 2 Elisabeth Bruyère Research Institute, Ottawa, Ontario, Canada
  3. 3 Biostatistics, Centre Hospitalier Universitaire de Lyon, Lyon, France
  4. 4 Department of Family Medicine, University of Calgary, Calgary, Alberta, Canada
  1. Correspondence to Dr Rene Leiva; rene.leiva{at}mail.mcgill.ca

Abstract

Rationale Ovulation confirmation is a fundamental component of the evaluation of infertility.

Purpose To inform the design of a larger clinical trial to determine the effectiveness of a new home-based pregnanediol glucuronide (PDG) urine test to confirm ovulation when compared with the standard of serum progesterone.

Methods In this observational prospective cohort study (single group assignment) in an urban setting (stage 1), a convenience sample of 25 women (aged 18–42 years) collected daily first morning urine for luteinisinghormone (LH), PDG and kept a daily record of their cervical mucus for one menstrual cycle. Serum progesterone levels were measured to confirm ovulation. Sensitivity and specificity were used as the main outcome measures. Estimation of number of ultrasound (US)-monitored cycles needed for a future study was done using an exact binomial CI approach.

Results Recruitment over 3 months was achieved (n=28) primarily via natural fertility regulation social groups. With an attrition rate of 22%, specificity of the test was 100% for confirming ovulation. Sensitivity varied depending on whether a peak-fertility mucus day or a positive LH test was observed during the cycle (85%–88%). Fifty per cent of participants found the test results easy to determine. A total of 73 US-monitored cycles would be needed to offer a narrow CI between 95% and 100%.

Conclusion This is first study to clinically evaluate this test when used as adjunct to the fertility awareness methods. While this pilot study was not powered to validate or test efficacy, it helped to provide information on power, recruitment and retention, acceptability of the procedures and ease of its use by the participants. Given this test had a preliminary result of 100% specificity, further research with a larger clinical trial (stage 2) is recommended to both improve this technology and incorporate additional approaches to confirm ovulation.

Trial registration number NCT03230084

  • reproductive medicine
  • subfertility
  • gynaecology

This is an open access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited, appropriate credit is given, any changes made indicated, and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/.

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Footnotes

  • Contributors RL conceived the study. RL, MMcN-K, HN, RE and TB designed the study, analysed the data and wrote the manuscript. RE performed the statistical analysis. MMcN-K and HN supervised the enrolment and participants during the study.

  • Funding This study was funded by Bruyère Foundation.

  • Competing interests None declared.

  • Ethics approval Ethics approval was sought and granted by the Bruyère Continuing Care Research Ethics Board.

  • Provenance and peer review Not commissioned; externally peer reviewed.

  • Data sharing statement All data relevant to the study are included in the article or uploaded as supplementary information.

  • Patient consent for publication Not required.

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