Observational studyBMJ open2019
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.
Observational study in BMJ open, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 13 papers.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Use of a Home-based Urinary Pregnanediol 3-glucuronide (PDG) Test to Confirm Ovulation
Comparing Cervical Mucus, PDG, LH, and Basal Body Temperature Combinations for Ovulation and Luteal Phase Identification Using the Premom Smartphone App Versus User-Read Test Results: A Prospective Observational Study
Who cites it
13 citing papers in PubMed.
- Performance of algorithms using wrist temperature for retrospective ovulation day estimate and next menses start day prediction: a prospective cohort study.Human reproduction (Oxford, England) · 2025Observational
- Insights into Perimenopause: A Survey of Perceptions, Opinions on Treatment, and Potential Approaches.Women (Basel, Switzerland) · 2025Article
- Comparison of Day-Specific Serum LH, Estradiol, and Progesterone with MiraMedicina (Kaunas, Lithuania) · 2024Article
- Current Ovulation and Luteal Phase Tracking Methods and Technologies for Fertility and Family Planning: A Review.Seminars in reproductive medicine · 2024Review
- Validation of urinary reproductive hormone measurements using a novel smartphone connected reader.Scientific reports · 2023Article
- Using Quantitative Hormonal Fertility Monitors to Evaluate the Luteal Phase: Proof of Concept Case Study.Medicina (Kaunas, Lithuania) · 2023Article
- Predicting serum hormone concentration by estimation of urinary hormones through a home-use device.Human reproduction open · 2023Article
- A time-resolved fluorescence microsphere-lateral flow immunochromatographic strip for quantitative detection of Pregnanediol-3-glucuronide in urine samples.Frontiers in bioengineering and biotechnology · 2023Article
- Complete Cycle Mapping Using a Quantitative At-Home Hormone Monitoring System in Prediction of Fertile Days, Confirmation of Ovulation, and Screening for Ovulation Issues Preventing Conception.Medicina (Kaunas, Lithuania) · 2022Article
- Urinary metabolomics reveals the biological characteristics of early pregnancy in pigs.Porcine health management · 2022Article
- Algorithms with Area under the Curve for Daily Urinary Estrone-3-Glucuronide and Pregnanediol-3-Glucuronide to Signal the Transition to the Luteal Phase.Medicina (Kaunas, Lithuania) · 2022Article
- Fertility Awareness-Based Methods for Women's Health and Family Planning.Frontiers in medicine · 2022Review
- The Fertility Indicator Equation Using Serum Progesterone and Urinary Pregnanediol-3-Glucuronide for Assessment of Ovulatory to Luteal Phase Transition.Medicina (Kaunas, Lithuania) · 2021Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
5 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
rationaleOvulation 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.
methodsIn 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.
resultsRecruitment 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%.
conclusionThis 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.
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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.