Accuracy of SPD Persona LH Assay When Compared to Ultrasound Observed Ovulation and Other Indices of Ovulation

Persona is a CE marked, natural method of contraception that works by monitoring hormone changes in a woman's urine to identify the days of her menstrual cycle when she is likely to become pregnant following unprotected intercourse. Persona consists of test sticks that measure luteinising hormone (LH) and estrone-3-glucuronide (E3G), which are read by a handheld monitor. This hormonal data is converted using a proprietary algorithm, into simple-to-understand information on the user's contraceptive status; a "red light" where she needs to abstain from intercourse to avoid pregnancy, or a "green light" where unprotected intercourse is unlikely to lead to pregnancy. A prospective 13 cycle reliability study has found Persona to be 94% effective.

This study will examine the relationship between the information provided by the Persona assays and ultrasound observed ovulation, along with other indicators of when a woman is fertile (basal body temperature (BBT) measurement and cervical secretion observations).

This is a single centre clinical study which will be conducted at the green-ivf clinic in Grevenbroich, Germany. The primary objective will be to assess the difference between the timing of the LH surge detected by Persona and observed ovulation by reference to transvaginal ultrasound examination.

In addition, comparison of Persona determined levels of LH and E3G will be made to urine and serum levels of these and other reproductive hormones. Comparison will also be made to BBT and cervical secretion observations which are indirect measurements of the fertile phase.

In order to achieve these objectives, a minimum of 40 female volunteers will be recruited by the study site either out of the patient pool coming for routine gynaecological examination or from the general population via newspaper advertisement.