Measuring Core Body Temperature Using TempuRing

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Fertility

Intervention / Treatment
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* Device: TempuRing


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 43 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: TempuRing<br>Women will wear the continuous temperature sensor, TempuRing, for 3 menstrual cycles. | Device: TempuRing<br> <br> * Other names: continuous temperature sensor;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Fertility, Continuous temperature monitor, Basal Body Temperature, Natural family planning