Accuracy and Clinical Research
The accuracy of Ovulation Double Check® Tests have been rigorously tested to ensure the highest quality product. In doing so, we tested Ovulation Double Check tests in laboratories, in clinics, and in homes of typical users.
In laboratory testing, Ovulation Double Check tests are 99% accurate at detecting progesterone metabolites (Pregnanediol) in urine.
Home Use Studies
Ovulation Double Check is an in vitro diagnostic device designed for self-testing in a home environment. Testing procedure involves home users collecting urine, performing the test, and reading the results without any formal education or training. Therefore, we performed studies to determine if our test could be performed and read correctly by normal women and in a typical home environment.
Home users were provided Ovulation Double Check® tests and asked to report their test results back to MFB Fertility. Users tracked ovulation via clinical signs such as cervical mucus, urine LH surge, and/or Clearblue Fertility Monitor. Users would self-report when they believed “peak” fertility had occurred. Ovulation Double Check® tests were taken both before and after “peak” fertility was detected. No users reported a positive Ovulation Double Check® test result before “peak” fertility. 92% of users reported seeing a positive Ovulation Double Check® test result after “peak” fertility was determined. The average time it took users to report a positive results was 3-6 days post “peak” fertility.
The Ovulation Double Check® test is performed exactly like a pregnancy or ovulation predictor test. Collect urine in a cup, dip the test strip, wait 5 minutes, then read your results. Fast, simple, and more cost effective than blood draws.
Several more clinical studies are planned for 2018. We look forward to collecting more data and improving the test as needed. We are always looking for study participants. Please contact us at firstname.lastname@example.org if you’re interested in joining our next study.
Research Publications validating the use of PdG as an accurate way to measure progesterone during ovulation, infertility detection and early pregnancy monitoring.
MFB Fertility was founded by scientists, scientists dedicated to empowering women to take control of their fertility. Before we developed the Ovulation Double Check (urine progesterone test) we did a complete survey of all current research studies in order to develop the most accurate product. Below are some of the most important studies on PdG that were used to develop Ovulation Double Check test and set its threshold value.
- Pope Paul VI Institute, Progesterone Support in Pregnancy; Indications for Use and Safety of progesterone in Pregnancy, The Medical & Surgical Practice of NaPro Technology.
- Long CA, Whitworth NS, Murphy HM, Bacquet K, Cowan BD, (1994) First-trimester rapid semiquantitative assay for urine pregnanediol glucuronide predicts gestational outcome with the same diagnostic accuracy as serial human chorionic gonadotropin measurements, Am J Obstet Gynecol, Vol 170(6) 1822-5.
- Ecochard R, Leiva R, Bouchard T, Boehringer H, Direito A, Mariani A, Fehring, R. (2013). Use of urinary pregnanediol 3-glucuronide to confirm ovulation. Steroids 78:1035-1040.
- Johnson S, Weddell S, Godbert S, Freundl G, Roos J, Gnoth C (2015) Development of the first urinary reproductive hormone ranges referenced to independently determined ovulation day (2015) Clin Chem Lab Med, Vol 53(7)
- Blackwell LF, Brown JB, Cooke DG. (1998). Definition of the potentially fertile period from urinary steroid excretion rates. Part II. A threshold value for pregnanediol glucuronide as a marker for the end of the potentially fertile period in the humanmenstrual cycle. Steroids, 63, 5.
- Blackwell LF, Vigil P, Alliende ME, Brown S, Festin M, Cooke D (2016) 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, Human Reproduction, Volume 31, Issue 2, 1 February 2016, Pages 445–453
- Vigil P, Blackwell LF, Cortés ME. The importance of fertility awareness in the assessment of a woman’s health. A review. Linacre Quarterly 79(4): 426–450, 2012.
- Taylor HW SE, Samuela SJ, Lasley BL (2003) Survival-time analysis of the postpartum anovulatory interval as measured by rise in urinary pregnanediol-3-glucuronide in lactating women. in Engineering in Medicine and Biology Society, 2003. Proceedings of the 25th Annual International Conference of the IEEE. 2003. IEEE.
- Roos J, Johnson S, Weddell S, Godehardt E, Schiffner J, Freundl G, Gnoth C (2015) Eur J Monitoring the menstrual cycle: Comparison of urinary and serum reproductive hormones referenced to true ovulation, Contraception and Repro Health Care, pages 438-450.
- Venners SA, Liu X, Perry MJ, Korrick SA, Li Z, Yang F, Yang J, Lasley BL, Xu X, Wang X (2006) Urinary estrogen and progesterone metabolite concentrations in menstrual cycles of fertile women with non-conception, early pregnancy loss or clinical pregnancy, Human Repro, Vol 21(9) 2272-80.
- Biro I, Bufa A, Wilhelm F, Manfai Z, Kilar P, Gocze M ( 2012) Urinary steroid profile in early pregnancy after in vitro fertilization, AOGS, Vol 91(5) 625-9.
- Leiva R, Bouchard T, Boehringer H, Abulla S, Ecochard R (2015) Random serum progesterone threshold to confirm ovulation, Steroids, Vol 101 125-129.
- Moran VH, Leathard HL, Coley J (2001) Urinary hormone levels during the natural menstrual cycle: the effect of age, J Endocrinol, Vol 170 157-164.
- Matias-Garcia PR, Martinez-Hurtado JL, Beckley A, Scmidmayr M, Seifert-Klauss V (2018) Hormone Smartphone Diagnostics, Methods Mol Biol, 1735:505-515.
- Rosetta L, Thalabard JC, Tanniuo J, Ducot B, Maitrot-Mantelet L, Roussett-Jablonski C, Bohet A, Bouyer J, Chimenes A, Slama R, (2017) Ovulatory status and menstrual cycle duration assessed by self-collection of urine on pH strips in a population-based sample of French women not using hormonal contraception, Eur J Contracept Reprod Health care, Vol 22(6) 450-458.