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Study of Axillary Skin Temperature as a Marker of Ovulation

The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2011 by Cambridge University Hospitals NHS Foundation Trust.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Cambridge Temperature Concepts
Information provided by:
Cambridge University Hospitals NHS Foundation Trust
ClinicalTrials.gov Identifier:
NCT01360684
First received: May 24, 2011
Last updated: May 25, 2011
Last verified: May 2011
  Purpose

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.


Condition
Infertility

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Pilot Study of Measuring Axillary Skin Temperature, Using DuoFertility, as a Marker of Ovulation in 10 Women of Childbearing Age

Resource links provided by NLM:


Further study details as provided by Cambridge University Hospitals NHS Foundation Trust:

Estimated Enrollment: 10
Study Start Date: July 2010
Estimated Study Completion Date: December 2011
Estimated Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years to 44 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Infertile females of child bearing age with regular menstrual cycles trying to get pregnant

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01360684

Contacts
Contact: Joanne Outtrim 01223 274446 jgo22@cam.ac.uk

Locations
United Kingdom
Cambridge University Hospital NHS Foundation Trust Recruiting
Cambridge, Cambridgeshire, United Kingdom, CB2 0QQ
Principal Investigator: Raj Mathur         
Sponsors and Collaborators
Cambridge University Hospitals NHS Foundation Trust
Cambridge Temperature Concepts
Investigators
Principal Investigator: Basil Matta Cambridge University Hospital NHS Foundation Trust
  More Information

No publications provided

Responsible Party: Dr Raj Mathur, Cambridge University Hospitals NHS Foundation Trust
ClinicalTrials.gov Identifier: NCT01360684     History of Changes
Other Study ID Numbers: A091932, 10/H0308/35
Study First Received: May 24, 2011
Last Updated: May 25, 2011
Health Authority: United Kingdom: Research Ethics Committee

Additional relevant MeSH terms:
Infertility
Genital Diseases, Female
Genital Diseases, Male

ClinicalTrials.gov processed this record on November 25, 2014