Clinical trial: Measuring Core Body Temperature Using TempuRing (NCT02462278)

Eligibility criteria:
Inclusion Criteria:

          1. Participant is willing and able to give informed consent for participation

          2. Females aged 21 to 43 years

          3. Have a body mass index (BMI) above 19 and below 29

          4. Regular menstrual cycles, i.e. no greater than 7 days difference between the shortest
             and longest cycle in the last 6 months

          5. Minimum menstrual cycle 24 days

          6. Maximum menstrual cycle 35 days

          7. Normal pap smear within the last year

          8. Willing to use the fertility device for at least 3 cycles

          9. Willing to fill in online questionnaires

         10. Willing to attend clinic up to 6 times per cycle for transvaginal ultrasound and blood
             tests

         11. Willing to perform LH urine tests at home twice a day from day 8 of cycle until it is
             positive

         12. Willing to document the last day of the previous menses and first day of the following
             menses.

         13. Willing to measure and record oral at the same time each morning.

         14. Normal pelvic ultrasound and blood results obtained during screening tests

        Exclusion Criteria:

          1. Any diagnosed systemic illnesses including thyroid disease, diabetes, yeast infection,
             Chlamydia, gonorrhea, trichomonas, bacterial vaginosis, inflammatory diseases, or are
             in an immuncompromised state

          2. Polycystic ovary disease

          3. Endometriosis or other chronic pelvic pain or pelvic pathology

          4. Taking steroid medication, including oral contraceptives or anti inflammatory drugs

          5. Pregnant
Female
Accepts Healthy Volunteers
Subject must be at least 21 Years old.
Subject must be at most 43 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? 1