An interventional study of TempuRing in Fertility, sponsored by Prima-Temp, Inc. Status unknown at 2 sites in United States. Open to female participants aged 21 Years to 43 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2017-04-06.
Sponsored by Prima-Temp, Inc · Not applicable, Interventional, and Other
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.
This is the only study on the registry with Prima-Temp, Inc as lead sponsor.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Women will wear the continuous temperature sensor, TempuRing, for 3 menstrual cycles.
Device: TempuRing
Also known as: continuous temperature sensor
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.
Time frame: Up to 3 months
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.
Time frame: Up to 3 months
This study is status unknown, as verified in Apr 2017. You cannot join it, but the record below documents what was studied.
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