Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 11:59 PM
Ignite Modification Date:
2025-12-24 @ 11:59 PM
NCT ID:
NCT01948258
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
Healthy Volunteers:
True
Sex:
FEMALE
Minimum Age:
18 Years
Maximum Age:
45 Years
Study:
NCT01948258
Study Brief:
Protocol Section:
NCT01948258