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Clearblue Advanced Fertility Monitor Consumer One Cycle at Home Study

Sponsored by SPD Development Company Limited

About this trial

Last updated 7 years ago

Study ID

0481

Status

Completed

Type

Interventional

Phase

N/A

Placebo

No

Accepting

18-75 Years
18 to 45 Years
Female
Female

Trial Timing

Ended 12 years ago

What is this trial about?

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.

What are the participation requirements?

Yes

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

No

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