Function of Fertell

Important: This information is intended to help you understand how the Fertell test works. To run the test, always refer to the instructions for use in the packaging.

The female test

The female test is a single-use, lateral flow dipstick that measures FSH (Follicle Stimulating Hormone) in urine as an indicator of ovarian reserve. The test is performed on day 3 of the menstrual cycle and is similar in design and use to an ovulation predictor test.

The device was calibrated to have a cut-off equivalent to an FSH concentration of 10IU/L in serum. A common criteria for normal ovarian reserve would be an early follicular phase FSH level of less than 10 IU/L and an elevated FSH level is an indicator of diminished ovarian reserve and reduced reproductive potential.

The results are delivered within 30 minutes and should be read within 60 minutes. The female test is greater than 95% accurate when compared to established laboratory tests (a commercially available serum FSH test).

The evaluation of the female test was conducted by Mr. Charles Kingsland at Liverpool Women's Hospital.

The test measures the concentration of FSH present in a first morning urine sample and is performed on day 3 of the menstrual cycle. It is similar in design and use to a pregnancy test.

The test is ready to read after 30 minutes and can be read for up to 60 minutes after taking the test. FSH present in the urine reacts and causes an antibody reaction on the test strip of the dipstick which shows as a clear red line on the test strip. The intensity of this line is proportional to the FSH concentration.

One red line in the large window indicates that ovarian reserve is likely to be normal, so efforts of trying to conceive should continue as normal.

A second red line in the large window that is lighter than the reference line in the control window also indicates that ovarian reserve is likely to be normal, so efforts of trying to conceive should continue as normal.

If the second red line is the same or darker than the reference line then a doctor should be consulted for further testing.

The male test

The male test is a single-use home test for measurement of the concentration of motile sperm in a semen sample.

The test simulates conditions in vivo. In use, the device defines a fixed volume of semen and any motile sperm present in the sample start to swim up through a column of fluid acting as artificial cervical mucus to a point where they can be labelled through an antibody reaction and subsequently detected on a test strip.

The device is operated by the user producing a sample, pressing a button and twisting a switch. The result is shown in a test window on the device: if the device shows two red lines it means the man has over 10 million motile sperm/ml semen (the WHO standard for normality - 20 million total sperm/ml semen, 50% motile), whereas if the device shows only one red line then the man is advised to seek further testing from a doctor.

The complete testing process takes 80 minutes (30 minutes for liquefaction of the semen sample and 50 minutes for the test to run).

The test is greater than 95% accurate when compared to established laboratory tests (Hamilton Thorne IVOS computer assisted semen analysis system and a capillary sperm migration test).

An evaluation of the male test conducted by Professor Chris Barratt at the University of Birmingham has been published in Human Reproduction and is available here.

A semen sample is produced directly into the collection container and allowed to liquify. This takes 30 minutes. The testing unit is then placed on top of the collection container and the the blue button is then pushed down to start the test.

In use the device defines a fixed volume of semen.

In addition, a column of fluid acting as artificial cervical mucus is layered onto the semen sample and automatically heated to body temperature.

Motile sperm start to swim up through the cervical mucus substitute to a point where they can be labelled through an antibody reaction and subsequently detected on a test strip.

No lines in the results window indicate the test has not been performed properly.

One line indicates the motile sperm concentration is below the cut-off level for normally expected values, so a doctor should be consulted for further testing.

Two red lines, however faint, indicates that motile sperm concentration is above the cut-off level for normally expected values, so the process of trying to conceive should continue as normal.