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Study of Axillary Skin Temperature as a Marker of Ovulation

NCT01360684 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 10

Last updated 2018-06-27

No results posted yet for this study

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. 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.

Conditions

Sponsors & Collaborators

  • Cambridge Temperature Concepts

    collaborator INDUSTRY

  • Joanne Outtrim

    lead OTHER

Principal Investigators

  • Raj Mathur · Cambridge University Hospital NHS Foundation Trust

Eligibility

Min Age
18 Years
Max Age
44 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2010-07-31
Primary Completion
2011-12-31
Completion
2015-01-31

Countries

  • United Kingdom

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01360684 on ClinicalTrials.gov