Fertility
Conditions
Keywords
Fertility, Continuous temperature monitor, Basal Body Temperature, Natural family planning
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.
Interventions
DEVICETempuRing
Sponsors
Prima-Temp, Inc
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
21 Years to 43 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Safety of TempuRing continuous temperature monitor device in women (incidence of adverse events) | Up to 3 months | Safety is evaluated by incidence of adverse events judged to be related to the device. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Acceptability and satisfaction questionnaire to assess the usability of TempuRing | Up to 3 months | Patients will complete an online questionnaire to assess the usability and comfort of the continuous temperature monitor. |
Countries
United States
Contacts
Primary ContactLauren Costantini, PhD
Outcome results
None listed