InfertilityNCT01360684
Study of Axillary Skin Temperature as a Marker of Ovulation
An observational study of Infertility, run by Joanne Outtrim at 1 site in United Kingdom.
Trial summary
Infertility is the most common reason women (aged 20-45yrs)see their GP, affecting 1 in 7 couples. Measuring basal body temperature is a technique that has been used since the 1930's to attempt to predict ovulation. Read more about this study
- Who is it for?
- Ages 18 to 44 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Infertility
- How many people
- 10 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Jul 2010to Jan 2015
- Phase
- Observational
- 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 18 to 44 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: Infertile females of child bearing age with regular menstrual cycles trying to get pregnant
Who may be able to join
- Participant is willing and able to give informed consent for participation
- Females aged 18 to 44 years.
- Referred with infertility to the Reproductive Medicine Clinic, Rosie Hospital
- 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 21 days
Show all 11Show fewer
- Maximum menstrual cycle 35 days
- Willing to wear a DuoFertility sensor continuously for 8 to 10 menstrual cycles;
- Willing to attend Rosie Hospital up to 5 times per cycle for TVS and blood tests
- Willing to perform twice daily LH urine tests at home from day 8 of cycle till positive
- Normal pelvic ultrasound and blood results obtained during screening tests
Who cannot join
- Aged younger than 18 years, or older than 44 years
- Have a BMI less than 18 or greater than 29
- Any diagnosed systemic illnesses, including but not restricted to thyroid disease, diabetes or inflammatory diseases
- Polycystic ovary disease
- Endometriosis or other pelvic pathology (including proven tubal disease)
- Taking steroids, including oral contraceptives or anti inflammatory drugs
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Cambridge University Hospital NHS Foundation Trust
Cambridge, Cambridgeshire, CB2 0QQ
About this study
Official title: Pilot Study of Measuring Axillary Skin Temperature, Using DuoFertility, as a Marker of Ovulation in 10 Women of Childbearing Age
Infertility is the most common reason women (aged 20-45yrs)see their GP, affecting 1 in 7 couples. Measuring basal body temperature is a technique that has been used since the 1930's to attempt to predict ovulation. Current NICE guidelines don't recommend the use of BBT charts to predict ovulation, as it has not been established to reliably confirm ovulation.
The DuoFertility sensor a CE marked Class la device provides a continuous accurate measure of axilla temperature whilst worn under the arm.
Read more
The investigators plan to compare the temperature measurements of the DuoFertility sensor with the gold standard transvaginal ultrasound scan obtained during 10 infertile women's menstrual cycles, up to 10 cycles per women.
The investigators aim to investigate if continuous axillary skin temperature measurement obtained from the DuoFertility sensor, provides comparable results for identifying the occurrence of ovulation as the gold standard transvaginal ultrasound scan.
- Conditions
- Infertility
- Medical subject headings
- Infertility
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 May 2011 (estimated)
- Study startJul 2010
- Primary completionDec 2011
- Study completionJan 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for InfertilityStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Joanne Outtrim
- Sponsor type
- University, hospital or other
- Collaborators
- Cambridge Temperature Concepts
- Responsible party
- Sponsor-investigator, Joanne Outtrim, Cambridge University Hospitals NHS Foundation Trust
- Investigators
- Raj Mathur, Principal investigator, Cambridge University Hospital NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01360684
- Sponsor's protocol ID
- A091932
- Other IDs
- 10/H0308/35
- Status last verified
- Jun 2018
- First submitted
- 24 May 2011
- Last updated
- 27 Jun 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study of Measuring Axillary Skin Temperature, Using DuoFertility, as a Marker of Ovulation in 10 Women of Childbearing Age
- ClinicalTrials.gov ID
- NCT01360684
- Acronym / sponsor ID
- A091932
- Conditions
- Infertility
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Joanne OuttrimUniversity, hospital or other
- Collaborators
- Cambridge Temperature Concepts
- Study start
- Jul 2010
- Primary completion
- Dec 2011 (actual)
- Study completion
- Jan 2015 (actual)
- First posted
- 26 May 2011 (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.
Infertility is the most common reason women (aged 20-45yrs)see their GP, affecting 1 in 7 couples. Measuring basal body temperature is a technique that has been used since the 1930's to attempt to predict ovulation. Current NICE guidelines don't recommend the use of BBT charts to predict ovulation, as it has not been established to reliably confirm ovulation.
The DuoFertility sensor a CE marked Class la device provides a continuous accurate measure of axilla temperature whilst worn under the arm.
The investigators plan to compare the temperature measurements of the DuoFertility sensor with the gold standard transvaginal ultrasound scan obtained during 10 infertile women's menstrual cycles, up to 10 cycles per women.
The investigators aim to investigate if continuous axillary skin temperature measurement obtained from the DuoFertility sensor, provides comparable results for identifying the occurrence of ovulation as the gold standard transvaginal ultrasound scan.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 44 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Infertile females of child bearing age with regular menstrual cycles trying to get pregnant
Key inclusion criteria (11 listed)
- Participant is willing and able to give informed consent for participation
- Females aged 18 to 44 years.
- Referred with infertility to the Reproductive Medicine Clinic, Rosie Hospital
- 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
Key exclusion criteria (6 listed)
- Aged younger than 18 years, or older than 44 years
- Have a BMI less than 18 or greater than 29
- Any diagnosed systemic illnesses, including but not restricted to thyroid disease, diabetes or inflammatory diseases
- Polycystic ovary disease
- Endometriosis or other pelvic pathology (including proven tubal disease)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jun 2018.
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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.
Raj Mathur principal investigator
Cambridge University Hospital NHS Foundation Trust
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Infertility, run by Joanne Outtrim at 1 site in United Kingdom.
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 11 inclusion and 6 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: finished, as of the sponsor's last update on 27 Jun 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
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 27 Jun 2018.