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 32-year-old woman comes to the hospital with vaginal spotting.  Her last menstrual period was 10 weeks ago. She has regular menses lasting for 6 days and repeating every 29 days. Medical history is significant for appendectomy and several complicated UTIs. She has multiple male partners, and she is inconsistent with using barrier contraceptives. Vital signs are normal.  Serum β-hCG level is 1800 mIU/mL, and a repeat level after 2 days shows an abnormal rise to 2100 mIU/mL.  Pelvic ultrasound reveals a thin endometrium with no gestational sac in the uterus.

Patient description (patient's own words): I just turned 32 and last morning I woke up with strange blood stains on my underwear. My last periods were more than 2 months ago, which is unusual for me because I used to have regular periods lasting for 6 days every 29 days, more or less. I had several UTIs in the past. I also had appendicitis. I'm currently seeing several men and, to be honest, some of them do struggle to wear a condom. I went to the hospital to check myself up and they told me that my vitals were normal. I also had a blood test on Monday, and my β-hCG level was 1800 mIU/mL, and then on Wednesday, it went up to 2100 mIU/mL. The gynecologist also did an ultrasound and she told me that, hopefully, there was no ovule.

Does the patient match the trial criteria? Contradiction