FertilityNCT02462278
Measuring Core Body Temperature Using TempuRing
A study testing TempuRing in people with Fertility, run by Prima-Temp, Inc at 2 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 21 to 43 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Fertility
- What is being tested?
- TempuRing
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 2 sitesUnited States
- Study dates
- Jul 2015to Jul 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 43 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Show all 14Show fewer
- 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
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
United States2 sites, 2 recruiting
- Recruiting
Partners HealthCare Connected Health
Boston, Massachusetts, 02114
Emily Caplan, 617-643-7976, PrimaTempStudy@partners.org
Bridget Gerstel, 1-617-643-6368, PrimaTempStudy@partners.org
- Recruiting
University of Washington Medical Center
Seattle, Washington, 98105
Sally Friend, MPH, 206-221-5318, sabdo@uw.edu
Emily Godfrey, MD
About this study
Official title: 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.
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.
- Conditions
- Fertility
- Being tested
- TempuRing
- Keywords
- Fertility, Continuous temperature monitor, Basal Body Temperature, Natural family planning
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TempuRingDevice
Also called continuous temperature sensor
| Study group | Role | What they receive |
|---|---|---|
| TempuRing | Experimental | Women will wear the continuous temperature sensor, TempuRing, for 3 menstrual cycles. Receives: Device: TempuRing |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Up to 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2015 (estimated)
- Study startJul 2015
- Primary completionJun 2018 (estimated)
- Study completionJul 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for FertilityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Prima-Temp, Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Lauren Costantini, PhD, Study director, Prima-Temp, Inc
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02462278
- Sponsor's protocol ID
- PT-001
- Status last verified
- Apr 2017
- First submitted
- 25 May 2015
- Last updated
- 6 Apr 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study Measuring Core Body Temperature Using TempuRing in Women of Childbearing Age
- ClinicalTrials.gov ID
- NCT02462278
- Acronym / sponsor ID
- PT-001
- Conditions
- Fertility
- Keywords
- Fertility, Continuous temperature monitor, Basal Body Temperature, Natural family planning
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- Prima-Temp, IncIndustry (pharma, biotech, devices)
- Study start
- Jul 2015
- Primary completion
- Jun 2018 (estimated)
- Study completion
- Jul 2018 (estimated)
- First posted
- 4 Jun 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| TempuRing | Experimental | Device: TempuRingWomen will wear the continuous temperature sensor, TempuRing, for 3 menstrual cycles. |
Who may qualify
- Ages
- 21 to 43 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (14 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TempuRingAlso: continuous temperature sensor | Device | TempuRing |
Primary outcome
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.
1 secondary outcome
Acceptability and satisfaction questionnaire to assess the usability of TempuRing
Time frame: Up to 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lauren Costantini, PhD study director
Prima-Temp, Inc
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing TempuRing in people with Fertility, run by Prima-Temp, Inc at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 6 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Lauren Costantini, PhD (415-816-3715, l.costantini@prima-temp.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety of TempuRing continuous temperature monitor device in women (incidence of adverse events) (time frame: Up to 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Apr 2017.