Methods

• 395womenwhowereseekingtoconceiveconsentedtousethemonitorforonemenstrualcycle(NCT01948258,ethicsapproved)

• WomenwererecruitedviaClearbluewebsite

• Semi-structured recorded telephone interviews,consistingof38questionsdefinedon theinterviewschedule,wereconductedwithintwoweeksoftheendofthestudycycle

• Samplesizewasbasedonthemesaturationandincluded14womenwhodidnotbecomepregnantand7womenwhoachievedpregnancy: (n=21).Notall volunteersansweredallquestions,soresultsarepresentedpernumberofrespondentstoeachquestion

• Thematiccontentwasanalysedtoidentifyemergentthemes.

Results

Asummaryofthevolunteers’opinionsofusingamonitortotimeintercourseforthepurposesofachievingpregnancyisprovidedinTable1.

Table 1: Summary of feedback on ‘concept’ of using a monitor to achieve pregnancy.

POSITIVE NEGATIVE

Betterunderstandingofcycle Encouragesobsessivebehaviour

Easiertotargetovulation Putspressureonpartner

Monitor‘takesresponsibility’ Makesintercoursefeelstaged

Decreasedworry/anxiety

Providesguidance

Cangetmedicalhelpearlierifneeded

Helpsmakeintercoursemoreefficient

• Ofwomenwhoresponded,94%thoughtitimportanttounderstandtheircyclewhentryingtoconceive, inorder totargetovulationmoreprecisely, tohelpreducestressandtospeedupconception,aswellastoallowthemtoassessifadditionalmedicalhelpwasneeded(Figure3)

• Elevenof17respondentsfeltthattheyunderstoodtheircyclebetterafterusingthemonitor,withthemonitoridentifyingcyclelength,timeofovulationandfertilewindowdifferentlytotheperceptionofsomewomen.Othersfeltthatthemonitorconfirmedtheirexistingunderstandingoftheircycle(Figure4)

• Amethodtoplanthetimingofintercourseappealedto20ofthe21respondents,forreasonswhichincludedincreasedfeelingsofcontrolandconvenience,alongwithreducedpressureandstress,andtomaximisethechancesofconception

• Afterstarting touse themonitor,13of17women responded that they feltdifferentlyabouttryingtoconceive,withmanystatingthattheyfeltmoreconfidentandincontrol,andreassuredthattheyweretakinganactiveroleinmaximisingthechancesofconception.Somenegativefeelingswerealsoexpressed,suchasaperceivedlossofspontaneity,pressureonthepartner,andintercourseseemingmorestagedorartificial.

• 86%ofthewomenusedthepregnancytestingfacility,andtheremainderdidn’tuseitbecausetheirperiodstarted.Thosewhousedthepregnancytestfounditstraightforwardandfeltthattheresultgivenwasclearandeasytounderstand

• Eighteenof the21respondentssaid theywouldshowthemonitor results to theirdoctor, inordertogivethedoctorasmuchinformationaspossibleandtodemonstratetheircommitmenttoconceiving.However,twowomensaidtheywouldnotshowthemonitortotheirdoctorincasetheirphysiciandidnothaveconfidenceinit

• Allofthe21respondentsagreedthatthemonitorwaseasytouse,andallratedithighly,withameanscoreof4.5onafivepointscale,wherefivewas“brilliant”

• AdvantagesanddisadvantagesoftheMonitorareshowninTable2.

Table 2: Summary of feedback on themes relating to the monitor.

POSITIVE NEGATIVE

Easytouse Concernsaboutprice

Keepsalldatatogether Touchscreennotasgoodasmobilephones/tablets

Onemethodforovulationandpregnancytest Can’trecordadditionaltrackingdata

Tellsyouwhentotest NotdiscreetenoughProvidesdirectionand‘takescontrol’whichgivespeaceofmind Oneroustodotestingeveryday

Helpfuldatadisplay(italsohelpsmyhusbandunderstandmycycle) Testingwindowistooshort

Ithighlightshighdaysaswellaspeakdays NeedsdatabackupIt could help you get medical interventionsoonerifrequiredbysharingresultswithHCPs Needsalternativepowersource

Attitudes and opinions of women using a novel fertility monitor whilst trying to conceive

Alice Herreboudt, Sarah Weddell, Sarah Johnson*

SPD Development Company Ltd., Priory Business Park, Bedford, MK44 3UP, UK*Presenting author Abstract number 0024, Poster number P47

Introduction

• Therearealimitednumberofdaysineachcyclewhenawomancanbecomepregnant,1knownasthe‘fertilewindow’

• Manywomenareunawareofthetimingoftheirfertilewindow,ormiscalculatewhenitoccurs.2 Thismeanstheymaybemissingthetimesduringtheircycleatwhichintercoursewouldgivethehighestchancesofconceiving

• Awoman’sindividualfertilewindowcanbeaccuratelyidentified4usinganewmonitor,Clearblue™AdvancedFertilityMonitor,whichtracksbothluteinising(LH)hormoneandestrone-3-glucuronide(E3G)3

• Thisenablesnotonlyidentificationofthedayofovulation(byLHsurge),butalsotheadditionaldaysofhighfertilitythatprecedeovulation,characterisedbyrisinglevelsofE3G(Figure1)

• ThismethodoffertilephasedetectionisthesameastheClearblueFertilityMonitorwhichhasbeenshowntoincreasethechanceofconceptionby89%,inthefirsttwocyclesofuse4

• Thenewmonitorhasatouchscreeninterface,withadditionalfunctionalitythatenablestheinputandstorageofinformationonmenstruation,intercourseandcyclehistory

• Userscanalso test forpregnancyon thesamemonitor,usingcolour-codedpregnancy teststicks(Figure2)

• Theaimofthisstudywastoinvestigatetheattitudesandopinionsofwomenusingthisnewmonitorwhilsttryingtoconceive.

1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 23 24 25 2622

Day of ovulation

Day of cycle

Ho

rmo

ne c

onc

entr

atio

n

Estrogen (E3G)

Luteinising hormone (LH)

Low fertility Low fertility

PEAK fertility

HIGH fertility

Clearblue™ is a trademark of SPD Swiss Precision Diagnostics GmbH (”SPD”). © 2013 SPD (except for any third party content identi�ed as such). All rights reserved.

Do you feel that you have a better understanding of your cycles now than you did before using the monitor?

Yes No

121086420

76543210

I did have an idea but this has confirmed it

The conception window is a different

length to what Ithought

Ovulation occurred at a different time to when I

thought it did

I realised that the previous methods I used we inaccurate

I didn’t get a peak The monitor didn’t give me more onformation

than other methods do

“It just confirmed what I already knew”

“I didn’t get a peak”

“It just backed up exactly what my temperature and charting had done before”

“The monitor didn’t totally match up with what I would have

understood about my cycle if I hadn’t been using it”

References1.WilcoxAJ.,et al.Timingofsexualintercourseinrelationtoovulation.NewEnglandJournalofMedicine.(1995)333:1517–1521.2.ZinamanM.,et al.Accuracyofperceptionofovulationdayinwomentryingtoconceive.CurrentMedicalResearchandOpinion.(2012)28:1–6.

3.BehreHM.,et al.PredictionofovulationbyurinaryhormonemeasurementswiththehomeuseClearblueFertilityMonitor:comparisonwithtransvaginalultrasoundscansandserumhormonemeasurements.HumanReproduction(2000)12:2478–2482.†

4.RobinsonJ.,et al.IncreasedpregnancyratewithuseofClearblueEasyFertilityMonitor.FertilityandSterility.(2007)87:329–34.†

†StudiesconductedusingtheClearblueFertilityMonitor.ThechemistryusedtodetectE3GandLHintheClearblueAdvancedFertilityMonitorandthemethodologyusedtoconverttestsignalstofertilitystatusarethesameasthoseusedintheClearblueFertilityMonitor.

AcknowledgmentsIMCMedicalCommunicationassistedwithpreparationofthisposter.

Declaration of interestAtpreparationoftheabstract,allauthorswereemployeesofSPDDevelopmentCompanyLtd.,afullyownedsubsidiaryofSPDSwissPrecisionDiagnosticsGmbH,themanufacturersofClearblue™products.ThestudywasfundedbySPDDevelopmentCompanyLtd.

‘Low’ is displayed on days when it isunlikelybutnot impossible thatyouwillbecomepregnant.

TheestrogenlevelrisesinthedaysbeforetheLHsurgeandhelpsthebodypreparefor ovulation. Detecting your rise inestrogenindicatesyouareatHIGHfertilityand‘High’isdisplayedontheMonitor.

AnLHsurgehappensabout24-36hoursbeforeovulation.DetectingyourLHsurgeindicatesyouareatyourmostfertiletimeand‘Peak’isdisplayedontheMonitor.

Figure 1: Changes in urine concentration of LH and E3G can be used to track fertility during the ovulatory cycle.

Figure 2: (A) The monitor showing its home screen, and test sticks (purple for fertility tests and blue for pregnancy tests); (B) Fertility testing results

screens for the Clearblue Advanced Fertility Monitor, with information from the instruction booklet for users to understand their results.

Figure 3: Responses regarding the appeal of a method to time intercourse.

Figure 4: Responses regarding the users’ understanding of their cycles.

7

6

5

4

3

2

1

0

To make sure I’m giving it

my best shot

To reduce stress

To maximise the chance of conception

It takes the pressure off having to try all the time

It’s too time consuming otherwise

It makes me feel more in

control

ConvenienceTo plan intercourse

To identify ovulation

Why does using a method to time intercourse appeal to you?

Discussion

• Manypositivebenefitswerereportedbywomenusingthenewfertilitymonitor;

- Increased informationprovisionmakingwomenfeel theyhadabetterunderstandingoftheircycles

- Betteridentificationoffertiledaysallowedthemtoplanintercoursetomaximisethechancesofconception

- Enabledpartnerstogainabetterunderstanding

- Givingmorecontrolandreassuranceoverall

• Somenegativeaspectswerealsoidentified,includingcostandlimitationsofthetechnology,aswellasfeelingthatintercoursewas‘staged’andlessspontaneous.AsrecruitmentwasviatheClearbluewebsite,selectionbiasshouldbeconsidered,howevertheparticipantsdorepresentwomenwhowouldchoosetousesuchamonitortoassistwithconception

• Due to the short nature of the study, some of the features of the monitor (such as thecyclesummarychart)couldnotbefullyexplored,andwomen’sresponsetogainingmoreunderstandingregardingtheirindividualcyclevariabilitycouldalsonotbeexamined

• The inclusionofpregnancy testingwithin the fertilitymonitor couldeliminate theneed formultipledevicesandaddtotheconvenienceappreciatedbytheusersoverthelongerterm.