Measuring Core Body Temperature Using TempuRing

April 5, 2017 updated by: Prima-Temp, Inc

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

25

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Massachusetts
    • Washington
      • Seattle, Washington, United States, 98105
        • Recruiting
        • University of Washington Medical Center
        • Contact:
          • Sally Friend, MPH
          • Phone Number: 206-221-5318
          • Email: sabdo@uw.edu
        • Principal Investigator:
          • Emily Godfrey, MD
        • Sub-Investigator:
          • Sarah Prager, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years to 43 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: TempuRing
Women will wear the continuous temperature sensor, TempuRing, for 3 menstrual cycles.
Device: TempuRing
Other Names:
  • continuous temperature sensor

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Safety of TempuRing continuous temperature monitor device in women (incidence of adverse events)
Time Frame: Up to 3 months
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
Time Frame: Up to 3 months
Patients will complete an online questionnaire to assess the usability and comfort of the continuous temperature monitor.
Up to 3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Prima-Temp, Inc

Investigators

  • Study Director: Lauren Costantini, PhD, Prima-Temp, Inc

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2015

Primary Completion (Anticipated)

June 1, 2018

Study Completion (Anticipated)

July 1, 2018

Study Registration Dates

First Submitted

May 25, 2015

First Submitted That Met QC Criteria

June 1, 2015

First Posted (Estimate)

June 4, 2015

Study Record Updates

Last Update Posted (Actual)

April 6, 2017

Last Update Submitted That Met QC Criteria

April 5, 2017

Last Verified

April 1, 2017

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • PT-001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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