Measuring Core Body Temperature Using TempuRing

Fertility Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02462278
• Other study ID #: PT-001
• Status: Recruiting
• Phase: N/A
• First received: May 25, 2015
• Last updated: April 5, 2017
• Start date: July 2015
• Est. completion date: July 2018

Study information

• Verified date: April 2017
• Source: Prima-Temp, Inc
• Contact: Lauren Costantini, PhD
• Phone: 415-816-3715
• Email: l.costantini[@]prima-temp.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 25
• Est. completion date: July 2018
• Est. primary completion date: June 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 21 Years to 43 Years

Eligibility

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

Related Conditions & MeSH terms

• Fertility

Intervention

Device:
• TempuRing

Locations

Country	Name	City	State
United States	Partners HealthCare Connected Health	Boston	Massachusetts
United States	University of Washington Medical Center	Seattle	Washington

Sponsors (1)

Lead Sponsor	Collaborator
Prima-Temp, Inc

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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