- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01360684
Study of Axillary Skin Temperature as a Marker of Ovulation
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.
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 Overview
Status
Conditions
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
Cambridgeshire
-
Cambridge, Cambridgeshire, United Kingdom, CB2 0QQ
- Cambridge University Hospital NHS Foundation Trust
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- 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
- 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
Exclusion Criteria:
- 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
Study Plan
How is the study designed?
Design Details
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Raj Mathur, Cambridge University Hospital NHS Foundation Trust
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- A091932
- 10/H0308/35 (Other Identifier: National Research Ethics Committee)
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.
Clinical Trials on Infertility
-
Assuta Hospital SystemsMaccabi Healthcare Services, IsraelCompletedInfertility, Female Infertility, Male InfertilityIsrael
-
Radboud University Medical CenterZonMw: The Netherlands Organisation for Health Research and DevelopmentCompletedPregnancy | Male Infertility | Female InfertilityNetherlands
-
Sapientiae InstituteTerminated
-
Esraa Gamal AhmedAin Shams Maternity HospitalUnknownUnexplained Female Infertility
-
King's College LondonNot yet recruitingInfertility | Infertility, Female | Infertility Unexplained | Infertility of Tubal Origin
-
Gazi UniversityCompletedMale Infertility | Unexplained Infertility
-
University of WashingtonEunice Kennedy Shriver National Institute of Child Health and Human Development...CompletedMale Infertility, AzoospermiaUnited States
-
Pacific Fertility CenterTerminatedPrimary Female Infertility | Secondary Female Infertility
-
Wake Forest University Health SciencesWithdrawnUterine Diseases | Endometriosis | Infertility Unexplained | Endometrial Diseases | Infertility; Female, NonimplantationUnited States
-
Istanbul University - Cerrahpasa (IUC)RecruitingInfertility | Sexual Dysfunction | Infertility, Male | Nurse's Role | Sexuality | Infertility; FemaleTurkey