Measuring Core Body Temperature Using TempuRing



Status:Recruiting
Conditions:Women's Studies
Therapuetic Areas:Reproductive
Healthy:No
Age Range:21 - 43
Updated:4/7/2017
Start Date:July 2015
End Date:July 2018
Contact:Lauren Costantini, PhD
Email:l.costantini@prima-temp.com
Phone:415-816-3715

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A Study Measuring Core Body Temperature Using TempuRing in Women of Childbearing Age

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.

Up to 25 healthy female volunteers or females currently trying to conceive will wear the
continuous temperature sensor for 3 menstrual cycles. Subjects will record their daily oral
temperature, and record their urine luteinizing hormone (LH) status via ovulation prediction
kits. Subjects will return to the clinic after a positive urinary LH test to receive
transvaginal ultrasound scans to confirm ovulation (ultrasounds will be repeated daily until
evidence of ovulation is documented by follicular collapse). Ovulation will also be
confirmed by serum progesterone. Subjects will complete an online questionnaire to assess
the usability and comfort of the continuous temperature monitor.

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
We found this trial at
2
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Boston, Massachusetts 02114
Phone: 617-643-7976
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1959 NE Pacific St
Seattle, Washington 98195
(206) 598-3300
Principal Investigator: Emily Godfrey, MD
Phone: 206-221-5318
University of Washington Medical Center University of Washington Medical Center is one of the nation's...
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