Mode
Text Size
Log in / Sign up
N/A N=395 Other

Clearblue Advanced Fertility Monitor Consumer One Cycle at Home Study

Pregnancy

Enrolled (actual)
395
Serious AEs
0.0%
Results posted
Nov 2018
Primary outcome: Primary: The Ability of the Volunteer to Use the New Clearblue Advanced Fertility Monitoring a Home Setting — 89.7 percentage of participants

Study Design & Population

Study type
Interventional
Phase
N/A
Interventions
Clearblue Advanced Fertility Monitor (Device)
Age
Adult · 18+ yrs
Sex
Female
Sponsor
SPD Development Company Limited
Primary completion
Nov 2013

Outcome Measures

OutcomeResultp-value
PRIMARY
The Ability of the Volunteer to Use the New Clearblue Advanced Fertility Monitoring a Home Setting
89.7
SECONDARY
Correct Identification of Monitor Status
91.2

Summary

This study will assess the use of the new Clearblue Advanced Fertility Monitor for one menstrual cycle in a home setting by female volunteers seeking to get pregnant.

Eligibility Criteria

Inclusion Criteria

  • Female
  • Aged 18 - 45 years
  • Willing to provide written informed consent to participate in the study and comply to the investigational procedures
  • Naive to similar marketed products including current Clearblue fertility monitor and Persona
  • Two natural cycles immediately prior to entering the study, each lasting between 21 and 42 days
  • Seeking to become pregnant

Exclusion Criteria

  • Unwilling to provide written informed consent to participate in the study or comply with study procedures
  • Employees of SPD, Proctor & Gamble or Alere
  • Have a condition that is known to be contra-indicated in pregnancy
  • Usually have menstrual cycles which are shorter than 21 days or longer than 42 days
  • Using or have used in their last 2 cycles, hormonal contraceptives including oral, emergency oral, implants, patches, transdermal injections, vaginal ring and progesterone intrauterine systems (IUS)
  • Using or have used in the last 2 cycles, infertility medications or hormone replacement therapy containing hCG or LH
  • Taking clomiphene citrate or other ovulation induction drugs
  • Are using any treatment which may affect the menstrual cycle
  • Have recently been pregnant, miscarried or breastfeeding
  • Have been diagnosed with polycystic ovarian syndrome (PCOS)
  • Are peri- or post-menopausal e.g. experiencing symptoms such as irregular menstrual periods, hot flushes, night sweats, sleep disturbances and mood swings
  • Are taking antibiotics containing tetracyclines
  • Have impaired liver or kidney function
  • Have previously participated in a SPD 'trying to conceive' study
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01948258). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

Back to search