Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TempuRing | Experimental | Women will wear the continuous temperature sensor, TempuRing, for 3 menstrual cycles. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TempuRing | Device |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Safety of TempuRing continuous temperature monitor device in women (incidence of adverse events) | Safety is evaluated by incidence of adverse events judged to be related to the device. | Up to 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Acceptability and satisfaction questionnaire to assess the usability of TempuRing | Patients will complete an online questionnaire to assess the usability and comfort of the continuous temperature monitor. | Up to 3 months |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Lauren Costantini, PhD | Contact | 415-816-3715 | l.costantini@prima-temp.com |
| Name | Affiliation | Role |
|---|---|---|
| Lauren Costantini, PhD | Prima-Temp, Inc | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Partners HealthCare Connected Health | Recruiting | Boston | Massachusetts | 02114 | United States |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| University of Washington Medical Center | Recruiting | Seattle | Washington | 98105 | United States |
|