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Completed

NCT Number: NCT01360684

Study of Axillary Skin Temperature as a Marker of Ovulation

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.

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Key information

Conditions

Infertility Genital Diseases Urogenital Diseases

Age range

18 year–44 year

Sex eligibility

Female

Study type

Observational

Primary location

Cambridge University Hospital NHS Foundation Trust

Cambridge, Cambridgeshire, CB2 0QQ, United Kingdom

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Sponsors and collaborators

Lead sponsor

Joanne Outtrim

Other

Collaborators

  • Cambridge Temperature Concepts

Registry information

Official study title

Pilot Study of Measuring Axillary Skin Temperature, Using DuoFertility, as a Marker of Ovulation in 10 Women of Childbearing Age

Important dates

Study start
2010
Primary completion
2011
Study completion
2015
First posted
May 26, 2011
Registry last updated
Jun 27, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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