Clearblue Advanced Fertility Monitor Consumer Three Cycle at Home Study

NCT02535260 | Withdrawn

• 1 other identifier: PROTOCOL-0682
• Study Type: observational
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

This study will assess the use of the new Clearblue Advanced Fertility Monitor in a home setting for three menstrual cycles or until pregnancy is achieved (whichever comes first) by female volunteers seeking to get pregnant.

Conditions

Pregnancy

Keywords

Pregnancy

Outcome Measures

Primary Outcomes (5)

• Behavioural change

  To compare change in behaviour from self-reported baseline behaviour to that reported in daily diaries including intercourse frequency, personal fertility knowledge and pregnancy testing behaviour

  3 months

• Behavioural change

  To observe % compliance of conducting tests

  3 months

• User comprehension

  To assess user comprehension of the Instructions for use

  3 months

• Product performance

  To assess performance of the Clearblue Advanced Fertility Monitor at identification of fertile window in relation to quantitative LH and E3G measurements

  3 months

• product performance

  To compare pregnancy test results to quantitative hCG concentration

  3 months

Secondary Outcomes (2)

• Behavioural change

  3 month

• Pregnancy rate

  3 months

Study Arms (1)

Fertility Monitor

Clearblue Fertility Monitor

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Probability Sample

Study Population

women wishing to become pregnant

You may qualify if:

• 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

You may not qualify if:

• 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
• Trying to conceive for12 months (for volunteers under 35) or trying to conceive for \>6 months ( for volunteers 35 or older)
• 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
• 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

Sponsors & Collaborators

• SPD Development Company Limited: lead

Study Sites (1)

SPD Development Company Ltd

Bedford, Bedfordshire, MK43 7JX, United Kingdom

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Urine samples collected throughout study

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 18, 2013
• First Posted: August 28, 2015
• Primary Completion: April 11, 2014
• Last Updated: February 8, 2019

Record last verified: 2019-02

Locations

GB (1)