Please select the eligibility criteria that correspond to the clinical trial below.
Title: Accuracy of SPD Persona LH Assay When Compared to Ultrasound Observed Ovulation and Other Indices of Ovulation
Brief Summary: This study will examine the performance of the Persona assays in identifying the time when risk of pregnancy is highest by comparing results to ultrasound observed ovulation and other indices of ovulation.


Options:
A: Inclusion Criteria:

* Female, age 18-45
* Have menstrual bleeds
* Seeking to become pregnant
* Willing to provide written, informed consent

Exclusion Criteria:

* Known condition to contra-indicate pregnancy
* Having treatment for infertility.
B: For Female participants

Inclusion Criteria:

* be between the age of 18 and 42
* be in a sexually active committed relationship with a man
* have a menstrual cycle range of 21-42 days

Exclusion Criteria:

* have not used Depo (injectable) contraception for the past 6 months
* have not used oral or patch hormonal contraception for the past 3 months
* have not breast-fed baby for at least three months
* have no known fertility problems
* not be using medications that interfere with fertility
* not smoke cigarettes; and
* not be pregnant.

For Male Participants

Inclusion criteria:

* be between the ages of 18 and 50
* be in a sexually active committed relationship with his lone woman partner.

Exclusion criteria:

* have no known fertility problems
C: Inclusion Criteria:

* Female
* Aged 18 - 40 years
* Menstrual cycle length between 23 and 35 days
* Had two natural cycles prior to study participation
* Using non-hormonal contraception to avoid pregnancy OR abstaining from intercourse for the last three months and the present cycle

N.B: Non hormonal contraception includes barrier methods such as male and female condoms, diaphragms or caps, non-hormonal intra-uterine devices such as coils, male and female sterilisation or natural family planning

Exclusion Criteria:

* Unwilling to provide written informed consent to participate in the study or comply with study procedures
* Pregnant
* Breastfeeding
* Has menopausal symptoms such as night sweats or hot flushes
* Using any hormonal treatments e.g. hormonal contraception, fertility treatments and hormone replacement therapy (except thyroxin)
* Taking antibiotics (based on decision by principle investigator)
* Has a diagnosis of polycystic ovarian syndrome (PCOS)
* Has impaired liver or kidney function
* Intending to use PERSONA as a contraceptive during the study period
* Contraindications to frequent blood sampling e.g. anaemia, hypotonia and blood clotting diseases
* Contraindications to frequent ultrasound examinations e.g. morbid obesity and recent abdominal surgery
D: Inclusion Criteria:

* Actively trying to conceive
* At least 2 regular consecutive cycles since last pregnancy/ miscarriage/ or since stopping breastfeeding
* Willing to use their own smartphone for the duration of this study and to download and install the study app
* Willing to disclose their pregnancy status and provide urine samples to test markers related to pregnancy and fertility
* Have internet access on their phone for the duration of the study
* Willing to give informed consent and comply with the investigational procedures

Exclusion Criteria:

* Currently or previously employed by SPD, Alere, Abbott, Unipath or P\&G, or affiliates
* Has an immediate relative\* currently or previously employed by SPD, Alere, Abbott, Unipath or P\&G or affiliates
* There is a reason why the volunteer should not get pregnant e.g. they are taking a medication or have a medical condition which means they should not get pregnant
* Trying to conceive for more than 6 months (if less than 35 years old) and more than 3 months (if 35 years old or over)
* Has been diagnosed with Polycystic Ovarian Syndrome (PCOS)
* Has PCOS symptoms: very irregular cycles, hirsutism
* Using or has previously used infertility medications or hormone replacement therapy containing hCG or LH (e.g Pregnyl)
* Are taking clomiphene citrate or other ovulation induction drugs
* Using any treatment which may affect the menstrual cycle (e.g. the contraceptive pill)
* Currently pregnant or breastfeeding
* Peri- or post-menopausal, e.g. experiencing symptoms: Irregular menstrual periods, hot flushes, night sweats, sleep disturbances, and mood swings
* Have abnormal liver or kidney function
* Taking medication containing tetracycline
* Using or undergoing any other medical treatment for fertility such as ovulation drugs, artificial insemination and assisted fertility such as IVF or ICSI
* Has a phone that is known to be incompatible with COTS

Answer: C