N/A
N=395
Clearblue Advanced Fertility Monitor Consumer One Cycle at Home Study
Pregnancy
Bottom Line
View on ClinicalTrials.gov: NCT01948258 ↗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
| Outcome | Result | p-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
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.