Clinical trial: Accuracy of SPD Persona LH Assay When Compared to Ultrasound Observed Ovulation and Other Indices of Ovulation (NCT01802060)

Eligibility criteria:
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
Female
Accepts Healthy Volunteers
Subject must be at least 18 Years old.
Subject must be at most 40 Years

Patient description (medical language): A 43-year-old woman, gravida 3 para 3, comes to the clinic complaining of recently painful menstrual cycles.  The patient's last menstrual period was 2 weeks ago. Urine β-hCG is negative. Menarche was at age 12, and menstrual periods occur every 28 days and lasts for 5 days.  She is sexually active with her husband and does not have pain with intercourse. BMI is 23 kg/m2 and Vital signs are normal.  On physical examination, the uterus is uniformly enlarged and tender. She is candidate for hysterectomy with the diagnosis of adenomyosis.

Patient description (patient's own words): I'm 43, and I paid a visit to my doctor because my last few periods were insanely painful. My last periods were 2 weeks ago. I already had three pregnancies that gave me the three lovely children. I did a urine test to check for potential pregnancy, and it came back negative. I started to have my periods at the age of 12, and I have been pretty regular with periods every 28 days for 5 days. I'm sexually active with my husband and I do not have any pain when we have sex. My BMI is 23 and my vitals were normal. The doctor performed a physical exam and found that my uterus was tender and enlarged. She proposed me a hysterectomy and diagnosed me with adenomyosis.

Does the patient match the trial criteria? Contradiction