Measuring Core Body Temperature Using TempuRing

Status unconfirmed · Not applicable

Conditions studied: Fertility

In brief

This study evaluates the safety and usability of a continuous temperature sensor for women. Data will compare the date of ovulation identified by the continuous temperature sensor to that of transvaginal ultrasound and serum progesterone levels. Subjects will also compare sensor results to once-daily oral temperatures and urine luteinizing hormone (LH) status.

Key facts

Study ID

NCT02462278

Run by

Prima-Temp, Inc

People needed

25

Starts

2015-07-01

Expected to finish

2018-07-01

Last updated by the study team

2017-04-06

Who can join

Age: 21 and older, up to 43. Sex: female. Healthy volunteers: accepted.

You may qualify if…

• Participant is willing and able to give informed consent for participation
• Females aged 21 to 43 years
• Have a body mass index (BMI) above 19 and below 29
• Regular menstrual cycles, i.e. no greater than 7 days difference between the shortest and longest cycle in the last 6 months
• Minimum menstrual cycle 24 days
• Maximum menstrual cycle 35 days
• Normal pap smear within the last year
• Willing to use the fertility device for at least 3 cycles
• Willing to fill in online questionnaires
• Willing to attend clinic up to 6 times per cycle for transvaginal ultrasound and blood tests
• Willing to perform LH urine tests at home twice a day from day 8 of cycle until it is positive
• Willing to document the last day of the previous menses and first day of the following menses.
• Willing to measure and record oral at the same time each morning.
• Normal pelvic ultrasound and blood results obtained during screening tests

You may not qualify if…

• Any diagnosed systemic illnesses including thyroid disease, diabetes, yeast infection, Chlamydia, gonorrhea, trichomonas, bacterial vaginosis, inflammatory diseases, or are in an immuncompromised state
• Polycystic ovary disease
• Endometriosis or other chronic pelvic pain or pelvic pathology
• Taking steroid medication, including oral contraceptives or anti inflammatory drugs
• Pregnant

Where it is running

• Partners HealthCare Connected Health — Boston, Massachusetts, United States (enrolling)
• University of Washington Medical Center — Seattle, Washington, United States (enrolling)

Full record on ClinicalTrials.gov

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