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词条 Draft:Ovusense
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{{AFC submission|d|reason|There are numerous issues with this draft. It reads too promotional and like an ADVERT for the company. The tone is set out more like a brochure or company website and does not follow Wikipedia guidelines for style. I would suggest reading through FIRST and make corrections prior to re-submission. |u=Rmilnes|ns=118|decliner=CNMall41|declinets=20181112195816|ts=20181112194255}} OvuSense Realtime Fertility MonitorPurposeThis page explains the development of the OvuSenseTM [1] [2] technology based on the original invention [3] [4] [5] by Butterworth [6] and Knowles [7] at University of Bristol in the United Kingdom. The page provides a background to clinical understanding, a summary of the clinical trials conducted to date and comparison with other methodologies.Detecting Ovulation

The thermogenic action of progesterone during ovulation in mammals, and evidence for the use of Basal Body Temperature (BBT) in detecting ovulation has been documented in the literature for over 100 years [8] [9]. More recently, a rule related to those temperature rises in humans was put forward by Barrett and Marshall (1969) – study size 1,898 cycles for 241 women [10], which holds that ovulation has occurred if in any window of 6 consecutive days there is a sustained rise of over 0.1°C for each day of 3 consecutive days. This work was later supported by McCarthy and Rockette (1983) – study size 8,496 cycles [11].

Predicting Ovulation

As outlined above, the literature established the clear relationship between an ovulation that has already occurred and a temperature rise. By better pinpointing when ovulation occurs, this technique improved on calendar based methods for predicting ovulation based on the known length of a menstrual cycle, the start date of the current menstrual cycle and the ovulation date from previous cycles.

However, this means BBT is still only really useful for women with regular cycles and/ or regular ovulation timing. The regularity of cycles is easily known of course by measuring the time between subsequent menstruations, but the regularity and timing of ovulation is generally unknown unless established through serial ultrasound folliculometry in multiple cycles to establish the presence of a dominant follicle which can then be shown to have ruptured, thereby establishing in each successive cycle when ovulation has taken place. In its committee opinion on "optimizing natural fertility", the American Society of Reproductive Medicine concludes "the time of peak fertility can vary considerably, even among women who have regular cycles" [12].

Ovulation predictor kits measure the luteinizing hormone (LH) surge that occurs 24-48 hours in advance of ovulation using a urine test. They too have proven to be extremely useful in women with regular cycles and ovulation, but McGovern PG et al. (2004) – study size 706 established that they can also produce false positive results[13] and this is largely believed to be due to elevated levels of LH in women with particular ovulatory issues such as Polycystic Ovarian Syndrome as reported by Robinson S et al (1992) - study size 63 [14] and more recently by Weddell and Schiffer (2017) – study size 385 women [15]

Hence, establishing a more accurate usage of temperature to enable it to predict during the current cycle might prove valuable in establishing ovulation, particularly in women who have irregular cycles and or irregular ovulation/ unknown timing of ovulation.

Both McCarthy et al and Barron et al (2005) [16] by way of their literature review, cast doubt on the ability of the temperature nadir to predict ovulation in the current cycle, mostly because of the difficulty in knowing when the true nadir has been reached. Other methods of determining the start and end points of ovulation using BBT have been examined in Hilgers and Bailey (1980) - study size 74 women with 24 cycles [17] and de Mouzon et al (1984) - study size 38 spontaneous cycles [18] but neither are particularly conclusive.

Freundl and Frank-Hermann (2014) – study size 51 women with 406 cycles [19] suggest that a combination of basal body temperature, cervical mucus and other cycle symptoms recorded using a standardised cycle chart according to the Sensiplan® [20] method could be used to identify the “BBT shift” day by means of a “Trigg's Tracking Signal”. However, this shift is also insufficient to predict the onset of ovulation.

While BBT was traditionally related to a single oral temperature measurement taken first thing on waking (in order to establish a proxy for the lowest basal measurement), more recent technological developments resulted in the application of BBT to multiple skin based temperature measurements either taken under the armpit (DuoFertility, [https://ifertracker.com/ iFertracker]) or otherwise on the wrist ([https://www.avawomen.com Avawomen]). Rollason et al. (2014) – study size 16 included cycles concluded [21] that the DuoFertility device may be useful for identifying ovulation in infertile women with regular cycles, and it is reasonable to conclude other skin based methods will likewise be able to identify ovulation once it has occurred in the cycle.

The ability of core body temperature (otherwise known as human body temperature), as opposed to oral BBT or skin based temperature, to more accurately track the level of progesterone and to provide real time prediction was suggested by Coyne al. (2000) – study size 11 cycles [22]. The study size was small most probably due to the impracticality of the measuring technique – a swallowed temperature probe. The OvuSense technology was developed based on this concept.

How does OvuSense work?

The OvuSense technology is embodied in a class II medical device regulated under the medical devices directive in Europe and approved for sale in the USA under FDA 510(k) number K122337. The device takes readings of core body temperature every 5 minutes using a specially designed sensor with a measurement resolution of 0.003°C. The sensor is placed in the vagina overnight and is shaped and used like a tampon, made of medical grade silicone, and tested and passed the standards of ISO 10993-1.

The device underwent a development trial in 2007 - 2008. This trial was used to optimise the sensor, and gather comparative data of the sensor versus ultrasound folliculometry, ovulation predictor kits and oral BBT temperature measurements. The data from this trial were presented at the ESHRE meeting in Istanbul in July 2012 in a poster by Papaioannou S, Aslam M (2012) Ovulation Assessment and Fertile Period Prediction by Portable Computerised Vaginal Temperature Analysis (online citation unavailable). The results from the clinical investigation demonstrated the basic functionality of OvuSense, and its ability to consistently track changes in basal body temperature.

The resulting product completed a second patient as own control clinical trial which focused on gold standard comparative measurement of OvuSense against ultrasound folliculometry, oral BBT temperature, and ovulation predictor kits to ensure no bias in the results. In total, 98 cycles of stratified data were produced with known results for all tests. These data were then used to construct a second generation algorithm. The data from this trial have been published in the following peer reviewed publications:

Papaioannou S, Delkos D, Pardey J (2014). Vaginal core body temperature assessment identifies pre-ovulatory body temperature rise and detects ovulation in advance of ultrasound folliculometry. European Society of Human Reproduction and Embryology 30th Annual Conference.[23]Papaioannou S, Aslam M (2013) Quality Index assessment of vaginal temperature based Fertility Prediction and comparison with LH Testing, Ultrasound Folliculometry and other home Cycle Monitors. American Society for Reproductive Medicine 69th Annual conference.[24]Papaioannou S, Aslam M (2013) User’s acceptability of Ovusense: a novel vaginal temperature sensor for prediction of the fertile period. J Obstet Gynaecol 33: 705–709.[25]Papaioannou S, Aslam M (2012) Ovulation Assessment By Vaginal Temperature Analysis (Ovusense Fertility Monitoring System) In Comparison To Oral Temperature Recording. American Society for Reproductive Medicine 68th Annual conference.[26]Patents

Building on the University of Bristol intellectual property, the OvuSense technology has been developed through two patent families "Method of Detecting and Predicting Ovulation"[27] [28], with extensions filed in the US [29] [30] and "Data Analysis System and Method" [31]

References

1. ^{{Cite web|url=https://euipo.europa.eu/eSearch/#details/trademarks/009848458|title=OvuSense European Trademark using EUIPO search|last=|first=|date=|website=euipo.europa.eu|archive-url=|archive-date=|dead-url=|access-date=2018-11-12}}
2. ^{{Cite web|url=http://tmsearch.uspto.gov/bin/showfield?f=doc&state=4802:6xjda9.2.1|title=OvuSense US Trademark using Trademark Electronic Search System (TESS)|last=|first=|date=|website=tmsearch.uspto.gov|archive-url=|archive-date=|dead-url=|access-date=2018-11-12}}
3. ^{{Cite web|url=https://worldwide.espacenet.com/publicationDetails/originalDocument?FT=D&date=20051228&DB=EPODOC&locale=en_EP&CC=EP&NR=1485690B1&KC=B1&ND=4|title=Indwelling Thermometer Espacenet link|last=|first=|date=|website=worldwide.espacenet.com|language=en|archive-url=|archive-date=|dead-url=|access-date=2018-11-12}}
4. ^{{Citation|title=United States Patent: 8684944 - Thermometer|url=http://patft.uspto.gov/netacgi/nph-Parser?d=PALL&p=1&u=/netahtml/PTO/srchnum.htm&r=1&f=G&l=50&s1=8684944.PN.&OS=PN/8684944&RS=PN/8684944|patent-number=8684944|issue-date=April 1, 2014|access-date=2018-11-12|inventor-last=Butterworth|inventor2-last=GB|inventor-first=Andrew}}
5. ^{{Citation|last=|first=|title=Thermometer|url=https://worldwide.espacenet.com/publicationDetails/biblio?FT=D&date=20050803&DB=EPODOC&locale=en_EP&CC=CN&NR=1650154A&KC=A&ND=4|volume=|pages=}}
6. ^{{Cite web|url=http://www.bris.ac.uk/vetscience/people/andrew-butterworth/index.html|title=Dr Andrew Butterworth - Bristol Veterinary School|last=Bristol|first=University of|website=www.bris.ac.uk|language=en-GB|access-date=2018-11-12}}
7. ^{{Cite web|url=http://www.bristol.ac.uk/vetscience/people/toby-g-knowles/index.html|title=Professor Toby Knowles - Bristol Veterinary School|last=Bristol|first=University of|website=www.bristol.ac.uk|language=en-GB|access-date=2018-11-12}}
8. ^{{Cite web|url=https://www.jstor.org/stable/i20177615|title=Vol. 2, No. 1982, Dec. 24, 1898 of The British Medical Journal on JSTOR|website=www.jstor.org|language=en|access-date=2018-11-12}}
9. ^{{Citation|title=Theodoor Hendrik van de Velde|date=2017-11-24|url=https://en.wikipedia.org/w/index.php?title=Theodoor_Hendrik_van_de_Velde&oldid=811899614|work=Wikipedia|language=en|access-date=2018-11-12}}
10. ^{{Cite journal|last=Barrett|first=J. C.|last2=Marshall|first2=J.|date=1969|title=The risk of conception on different days of the menstrual cycle|journal=Population Studies|volume=23|issue=3|pages=455–461|doi=10.1080/00324728.1969.10405297|issn=0032-4728|pmid=22073960}}
11. ^{{Cite journal|last=McCarthy|first=J. J.|last2=Rockette|first2=H. E.|date=1983|title=A comparison of methods to interpret the basal body temperature graph|journal=Fertility and Sterility|volume=39|issue=5|pages=640–646|issn=0015-0282|pmid=6840307}}
12. ^{{Cite journal|date=2013|title=Optimizing natural fertility: a committee opinion|url=https://www.fertstert.org/article/S0015-0282(13)00790-5/fulltext|journal=Fertility and Sterility|language=English|volume=100|issue=3|pages=631–637|doi=10.1016/j.fertnstert.2013.07.011|pmid=23993665|issn=0015-0282|via=|author1=Practice Committee of American Society for Reproductive Medicine in collaboration with Society for Reproductive Endocrinology Infertility}}
13. ^{{Cite journal|last=McGovern|first=Peter G.|last2=Myers|first2=Evan R.|last3=Silva|first3=Susan|last4=Coutifaris|first4=Christos|last5=Carson|first5=Sandra A.|last6=Legro|first6=Richard S.|last7=Schlaff|first7=William D.|last8=Carr|first8=Bruce R.|last9=Steinkampf|first9=Michael P.|date=2004|title=Absence of secretory endometrium after false-positive home urine luteinizing hormone testing|journal=Fertility and Sterility|volume=82|issue=5|pages=1273–1277|doi=10.1016/j.fertnstert.2004.03.070|issn=0015-0282|pmid=15533341}}
14. ^{{Cite journal|last=Robinson|first=S.|last2=Rodin|first2=D. A.|last3=Deacon|first3=A.|last4=Wheeler|first4=M. J.|last5=Clayton|first5=R. N.|date=1992|title=Which hormone tests for the diagnosis of polycystic ovary syndrome?|journal=British Journal of Obstetrics and Gynaecology|volume=99|issue=3|pages=232–238|issn=0306-5456|pmid=1296589}}
15. ^{{Cite web|url=https://www.clearblue.com/sites/default/files/eshre-2017-poster.pdf|title=Can likelihood of natural pregnancy be predicted from demographics and LH surge characteristics?|last=Weddell|first=S|date=|website=|archive-url=|archive-date=|dead-url=|access-date=}}
16. ^{{Cite journal|last=Barron|first=Mary Lee|last2=Fehring|first2=Richard J.|date=2005|title=Basal body temperature assessment: is it useful to couples seeking pregnancy?|journal=MCN. The American Journal of Maternal Child Nursing|volume=30|issue=5|pages=290–296; quiz 297–298|issn=0361-929X|pmid=16132004}}
17. ^{{Cite journal|last=Hilgers|first=T. W.|last2=Bailey|first2=A. J.|date=1980|title=Natural family planning. II. Basal body temperature and estimated time of ovulation|journal=Obstetrics and Gynecology|volume=55|issue=3|pages=333–339|issn=0029-7844|pmid=7360431}}
18. ^{{Cite journal|last=de Mouzon|first=J.|last2=Testart|first2=J.|last3=Lefevre|first3=B.|last4=Pouly|first4=J. L.|last5=Frydman|first5=R.|date=1984|title=Time relationships between basal body temperature and ovulation or plasma progestins|journal=Fertility and Sterility|volume=41|issue=2|pages=254–259|issn=0015-0282|pmid=6421622}}
19. ^{{Cite journal|last=Freundl|first=Günter|last2=Frank-Herrmann|first2=Petra|last3=Brown|first3=Simon|last4=Blackwell|first4=Leonard|date=2014|title=A new method to detect significant basal body temperature changes during a woman's menstrual cycle|journal=The European Journal of Contraception & Reproductive Health Care: The Official Journal of the European Society of Contraception|volume=19|issue=5|pages=392–400|doi=10.3109/13625187.2014.948612|issn=1473-0782|pmid=25159914}}
20. ^{{Cite web|url=http://www.sensiplan.be/default.asp?iID=GDLHJM|title=What is Sensiplan? {{!}} Sensiplan|last=Laet|first=Marc De|website=www.sensiplan.be|access-date=2018-11-12}}
21. ^{{Cite journal|last=Rollason|first=Jennie Cb|last2=Outtrim|first2=Joanne G.|last3=Mathur|first3=Raj S.|date=2014|title=A pilot study comparing the DuoFertility(®) monitor with ultrasound in infertile women|journal=International Journal of Women's Health|volume=6|pages=657–662|doi=10.2147/IJWH.S59080|issn=1179-1411|pmc=4106957|pmid=25075200}}
22. ^{{Cite journal|last=Coyne|first=M. D.|last2=Kesick|first2=C. M.|last3=Doherty|first3=T. J.|last4=Kolka|first4=M. A.|last5=Stephenson|first5=L. A.|date=2000|title=Circadian rhythm changes in core temperature over the menstrual cycle: method for noninvasive monitoring|journal=American Journal of Physiology. Regulatory, Integrative and Comparative Physiology|volume=279|issue=4|pages=R1316–1320|doi=10.1152/ajpregu.2000.279.4.R1316|issn=0363-6119|pmid=11003999}}
23. ^{{Cite web|url=http://www.posters2view.eu/eshre2014/data/247.pdf|title=Vaginal core body temperature assessment|last=Papaoiannou|first=Spyros|date=|website=ESHRE|archive-url=|archive-date=|dead-url=|access-date=}}
24. ^{{Cite journal|last=Papaioannou|first=S.|last2=Al Wattar|first2=B.H.|last3=Milnes|first3=R.C.|last4=Knowles|first4=T.G.|date=2013|title=Quality index assessment of vaginal temperature based fertility prediction and comparison with luteinising hormone testing, ultrasound folliculometry and other home cycle monitors|url=https://www.fertstert.org/article/S0015-0282(13)01726-3/fulltext|journal=Fertility and Sterility|language=English|volume=100|issue=3|pages=S326–S327|doi=10.1016/j.fertnstert.2013.07.947|issn=0015-0282|via=}}
25. ^{{Cite journal|last=Papaioannou|first=S.|last2=Aslam|first2=M.|last3=Al Wattar|first3=B. H.|last4=Milnes|first4=R. C.|last5=Knowles|first5=T. G.|date=2013|title=User's acceptability of OvuSense: a novel vaginal temperature sensor for prediction of the fertile period|journal=Journal of Obstetrics and Gynaecology: The Journal of the Institute of Obstetrics and Gynaecology|volume=33|issue=7|pages=705–709|doi=10.3109/01443615.2013.817984|issn=1364-6893|pmid=24127960}}
26. ^{{Cite journal|last=Papaioannou|first=S.|last2=Aslam|first2=M.|last3=Al Wattar|first3=B.H.|last4=Milnes|first4=R.C.|last5=Knowles|first5=T.G.|date=2012|title=Ovulation assessment by vaginal temperature analysis (the ovusense advanced fertility monitoring system) in comparison to oral temperature measurement|url=https://www.fertstert.org/article/S0015-0282(12)01324-6/fulltext|journal=Fertility and Sterility|language=English|volume=98|issue=3|pages=S160|doi=10.1016/j.fertnstert.2012.07.590|issn=0015-0282|via=}}
27. ^{{Cite web|url=https://register.epo.org/application?number=EP07804149&tab=main|title=Method of Detecting and Predicting Ovulation - EPO|last=|first=|date=|website=register.epo.org|archive-url=|archive-date=|dead-url=|access-date=2018-11-12}}
28. ^{{Citation|title=United States Patent: 8496597 - Method of detecting and predicting ovulation and the period of fertility|url=http://patft.uspto.gov/netacgi/nph-Parser?Sect1=PTO1&Sect2=HITOFF&d=PALL&p=1&u=/netahtml/PTO/srchnum.htm&r=1&f=G&l=50&s1=8496597.PN.&OS=PN/8496597&RS=PN/8496597|patent-number=8496597|issue-date=July 30, 2013|access-date=2018-11-12|inventor-last=James|inventor2-last=GB|inventor3-last=GB|inventor-first=Michael Howard|inventor3-first=Toby Grahame}}
29. ^{{Citation|title=United States Patent: 9155522 - Method of detecting and predicting ovulation and the period of fertility|url=http://patft.uspto.gov/netacgi/nph-Parser?Sect1=PTO2&Sect2=HITOFF&u=/netahtml/PTO/search-adv.htm&r=1&p=1&f=G&l=50&d=PTXT&S1=9155522&OS=9155522&RS=9155522|patent-number=9155522|issue-date=October 13, 2015|access-date=2018-11-12|inventor-last=James|inventor2-last=GB|inventor3-last=GB|inventor-first=Michael Howard|inventor3-first=Toby Grahame}}
30. ^{{Citation|title=United States Patent: 9155523 - Method of detecting and predicting ovulation and the period of fertility|url=http://patft.uspto.gov/netacgi/nph-Parser?Sect1=PTO2&Sect2=HITOFF&u=/netahtml/PTO/search-adv.htm&r=2&p=1&f=G&l=50&d=PTXT&S1=9155523&OS=9155523&RS=9155523|patent-number=9155523|issue-date=October 13, 2015|access-date=2018-11-12|inventor-last=James|inventor2-last=GB|inventor3-last=GB|inventor-first=Michael Howard|inventor3-first=Toby Grahame}}
31. ^{{Cite web|url=https://worldwide.espacenet.com/publicationDetails/originalDocument?FT=D&date=20141231&DB=EPODOC&locale=en_EP&CC=WO&NR=2014207484A1&KC=A1&ND=6|title=Data Analysis System and Method - EPO|last=|first=|date=|website=worldwide.espacenet.com|language=en|archive-url=|archive-date=|dead-url=|access-date=2018-11-12}}

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