Clinical trial NCT02462278: Measuring Core Body Temperature Using TempuRing
Official title: A Study Measuring Core Body Temperature Using TempuRing in Women of Childbearing Age
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Fertility
Keywords: Fertility
Continuous temperature monitor
Basal Body Temperature
Natural family planning
Lead sponsor: Prima-Temp, Inc
Sponsor class: INDUSTRY
First posted: 2015-06-04
Enrollment: 25
Sex: FEMALE
Minimum age (years): 21
Maximum age (years): 43
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: 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.

Detailed description: 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.

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

Primary outcomes:
measure: Safety of TempuRing continuous temperature monitor device in women (incidence of adverse events)
timeFrame: Up to 3 months
Secondary outcomes:
measure: Acceptability and satisfaction questionnaire to assess the usability of TempuRing
timeFrame: Up to 3 months
Other outcomes:
Locations:
city: Boston
country: United States
facility: Partners HealthCare Connected Health
state: Massachusetts
city: Seattle
country: United States
facility: University of Washington Medical Center
state: Washington
Study officials:
affiliation: Prima-Temp, Inc
name: Lauren Costantini, PhD
role: STUDY_DIRECTOR
References: