Friday, July 1, 2011

Telemedicine Fertility Monitor As Successful As In Vitro Fertilization

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Close monitoring of core temperature can be more successful than IVF

Shamus Husheer’s opening line as a speaker is guaranteed to get him a laugh: “My name is Shamus Husheer and my job is to get the women of Britain pregnant.”

Behind the laughs, though, Mr. Husheer has developed a technology that is helping thousands of women get pregnant without recourse to drugs or invasive techniques for a fraction of the cost of IVF. In the U.K. a cycle of IVF costs on average some £4,500 ($7,200).

New Zealand born Mr. Husheer, who started his company, Cambridge Temperature Concepts, straight after being awarded a PhD from the chemistry department at Cambridge University says the fertility monitor, called DuoFertility, is as effective as conventional IVF.

“We published a peer-reviewed paper that showed that six months use of the monitor has the same success rate as a round of IVF. ”

They are confident that unpublished research which uses additional data will show that a year of use is better than IVF.

So confident is Mr. Husheer, that the company offers a money-back guarantee. If a woman is not pregnant after 12 month’s use, and has complied with the instructions, then the company will refund the £495.

The medicine underpinning the technology was established in the 1930s and relies on differences in a woman’s body basal temperature (BBT)* at the time of ovulation.

“This change in temperature is only about 0.3ºC measured over the whole month,” said Mr. Husheer. “But a woman’s temperature can change by as much as 2.5ºC a day.” The technology to do that, which is patented, came directly from Mr. Husheer’s PhD in instrumentation, finding signals hidden among very noisy data.

Solving patient compliance

DuoFertility comprises a small sensor, slightly larger in diameter than a €1 coin, which a woman wears under her arm, affixed with medical tape. The sensor, which can take up to 20,000 readings a day, has to be worn all night and preferably during the day as well. It is designed to fit into the natural pocket under the arm.

The monitor has to be synched with the base station which is connected to a PC. The data is then relayed back. From the information it can identify the day of ovulation and suggest the three day fertilization window.

The woman can use the base station to report other things with the temperature data, such as the first day of her menstrual cycle, or report back when intercourse has taken place. It can also be used to report events such as interrupted sleep, which will affect the readings, or if the woman is ill.

“Patient compliance, in other words patients following the courses prescribed for them, is a real issue in healthcare. Because this is a telemedicine device, we can see if the woman has complied.”

The device has been licensed by the British NHS and is undergoing approval by the U.S. Food and Drug Administration. The NHS is looking at using the system for the 4,000 patients a year who have unexplained infertility. Since the system is as least as effective as IVF, it means fewer patients need go down the medical route. “From a woman’s perspective, IVF is pretty awful. With us, all they have to do is wear a patch.”

Data capture is transforming business

And in a great example of how data capture is transforming businesses, the monitoring data has proved to be a valued resource for sleep researchers. The monitor contains a three-axis accelerometer which it uses to determine when the woman is asleep which is when the BBT can be established.

“For the first time, we have extensive data on what normal sleep looks like,” said Mr. Husheer. Sleep monitoring is usually done in expensive sleep monitoring stations and typically only for people with sleep problems. His company is working with the NHS to use the monitor in other sleep trials.

Telemedicine has long been hailed as one of the great advances that technology will bring, but has often failed to live up to its promise. Part of the problem, says Mr. Husheer is that the wrong sort of monitoring is attempted. “Typically it has been attempted for cardiac cases, which requires constant 24×7 monitoring. Even now the technology isn’t really up to it.”

Having established the efficacy of their product to detect very small temperature changes, Mr. Husheer says that the medical community is looking closely at using similar technology for post-operative care. “In the U.K. alone there are some nine million operations a year, compared with 35,000 couples looking for fertility treatment.”

Other uses include monitoring infants for sudden infant death syndrome and patients suffering from Type 1 diabetes.

*Body basal temperature

A woman’s BBT patterns consist of two phases during the menstrual cycle, her BBT is lower before ovulation than after. The small increase in BBT, of the order of 0.3ºC occurs within 48 hours of ovulation and will remain elevated until her next period.

However recording BBT has historically been difficult. Traditional methods involve taking an oral, rectal or vaginal measurement at the same time each morning which must be taken on waking. However, even the act of waking or getting out of bed will increase her temperature, leading to inaccuracies in the measurement. Wall Street Journal

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