NCT02462278

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
25

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jul 2015

Typical duration for not_applicable

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 25, 2015

Completed
10 days until next milestone

First Posted

Study publicly available on registry

June 4, 2015

Completed
27 days until next milestone

Study Start

First participant enrolled

July 1, 2015

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2018

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2018

Completed
Last Updated

April 6, 2017

Status Verified

April 1, 2017

Enrollment Period

2.9 years

First QC Date

May 25, 2015

Last Update Submit

April 5, 2017

Conditions

Fertility

Keywords

FertilityContinuous temperature monitorBasal Body TemperatureNatural family planning

Outcome Measures

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.

    Up to 3 months

Secondary Outcomes (1)

  • Acceptability and satisfaction questionnaire to assess the usability of TempuRing

    Up to 3 months

Study Arms (1)

TempuRing

EXPERIMENTAL

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

Device: TempuRing

Interventions

TempuRingDEVICE
Also known as: continuous temperature sensor
TempuRing

Eligibility Criteria

Age21 Years - 43 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Participant is willing and able to give informed consent for participation
  • Females aged 21 to 43 years
  • Have a body mass index (BMI) above 19 and below 29
  • Regular menstrual cycles, i.e. no greater than 7 days difference between the shortest and longest cycle in the last 6 months
  • Minimum menstrual cycle 24 days
  • Maximum menstrual cycle 35 days
  • Normal pap smear within the last year
  • Willing to use the fertility device for at least 3 cycles
  • Willing to fill in online questionnaires
  • Willing to attend clinic up to 6 times per cycle for transvaginal ultrasound and blood tests
  • Willing to perform LH urine tests at home twice a day from day 8 of cycle until it is positive
  • Willing to document the last day of the previous menses and first day of the following menses.
  • Willing to measure and record oral at the same time each morning.
  • Normal pelvic ultrasound and blood results obtained during screening tests

You may not qualify if:

  • Any diagnosed systemic illnesses including thyroid disease, diabetes, yeast infection, Chlamydia, gonorrhea, trichomonas, bacterial vaginosis, inflammatory diseases, or are in an immuncompromised state
  • Polycystic ovary disease
  • Endometriosis or other chronic pelvic pain or pelvic pathology
  • Taking steroid medication, including oral contraceptives or anti inflammatory drugs
  • Pregnant

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Partners HealthCare Connected Health

Boston, Massachusetts, 02114, United States

RECRUITING

University of Washington Medical Center

Seattle, Washington, 98105, United States

RECRUITING

Study Officials

  • Lauren Costantini, PhD

    Prima-Temp, Inc

    STUDY DIRECTOR

Central Study Contacts

Lauren Costantini, PhD

CONTACT

415-816-3715l.costantini@prima-temp.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 25, 2015

First Posted

June 4, 2015

Study Start

July 1, 2015

Primary Completion

June 1, 2018

Study Completion

July 1, 2018

Last Updated

April 6, 2017

Record last verified: 2017-04

Locations

US(2)