CClinicalTrials.gg
Status unknownNCT02462278Updated Apr 6, 2017

Measuring Core Body Temperature Using TempuRing

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

The sponsor has not verified this record recently (last verified Apr 2017), so the status shown — last known as Recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
25
Allocation
Not applicable
Ages
21 Years to 43 Years
Sex
Female
01

Study 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.

Read the 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.

02

Conditions studied

  • Fertility

Keywords

  • Fertility
  • Continuous temperature monitor
  • Basal Body Temperature
  • Natural family planning
03

In context

Lead sponsor

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.

04

Who can participate

Ages eligible
21 Years to 43 Years
Sexes eligible
Female
Accepts 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

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
05

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
25 participants (estimated)

Study arms

  • Experimental
    TempuRing

    Women will wear the continuous temperature sensor, TempuRing, for 3 menstrual cycles.

    Device: TempuRing

Interventions

  • DeviceTempuRing

    Also known as: continuous temperature sensor

06

What researchers measure

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

07

Study locations

2 of 2 sites recruiting
  • Partners HealthCare Connected Health
    Boston, Massachusetts 02114, United States
    Recruiting
  • University of Washington Medical Center
    Seattle, Washington 98105, United States
    • Sally Friend, MPH · Contact · sabdo@uw.edu · 206-221-5318
    • Emily Godfrey, MD · Principal investigator
    • Sarah Prager, MD · Sub investigator
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 6, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02462278
Lead sponsor
Prima-Temp, Inc
Responsible party
Sponsor
First posted
Jun 4, 2015
Start date
Jul 2015
Primary completion
Jun 2018 (estimated)
Completion
Jul 2018 (estimated)
Last update
Apr 6, 2017

Study contacts

Lauren Costantini, PhD
Contact
l.costantini@prima-temp.com
415-816-3715
Lauren Costantini, PhD
study director · Prima-Temp, Inc

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

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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