Gynaecology Malignancies and other Chronic Conditions

Methods

This study is aimed to last 18 to 24 months and to recruit a minimum of 100 family siblings. Our aim is to recruit all the sisters in one family. This would be a pilot study. No similar studies have been done in the past to ascertain the number of women required to obtain an 80% statistical power for the study. Trained Fertility care practitioners and instructors (FCI/P) would teach women how to chart their cycles in accordance with the CrMS. Women would be asked to participate in this study and give their consent. They would be aged between 18 and 30 years and must be off any form of female hormone therapy for at least 6 months. A second group of young girls would be recruited with parental consent at the onset of puberty up till age 18 years. Sibling sisters are recruited and compared to each other and to other women. All clients would have a minimum of 4 visits with the FCI/P to learn the CrMS prior to blood sampling for oestradiol and progesterone level in their 3rd menstrual cycle. In those women who would not show signs of ovulation during this period, further visits would be required and blood sampling would be postponed. A database would record the family and personal medical history, current and past drug history, smoking and alcohol history as well as parity and age at first pregnancy, past use of female hormones, age at menarche and body mass index. The mucus cycle score, tail-end and premenstrual bleeding, length of cycle, luteal phase and other biomarkers used routinely in the CrMS are recorded at the end of the third menstrual cycle and again after one year.

Statistical analysis using STATA statistical package would be performed to analyse the data.

Funding required: there are as yet no FCI/P on the island except for M Spiteri who currently works in the UK. The cost of training 2 practitioners in the UK would be £3500 to £4000 sterling each. This would include course fees, basic accommodation and flights. The instructor course which could be conducted in Malta on the other hand would cost about 2000 euro each. These costs exclude the time off work taken to attend the 9-day theoretical course and the time to instruct clients. An instructor cannot deal with advanced cases in CrMS and must refer such clients to a practitioner. M Spiteri would be very happy to help with such women.

An oestradiol/progesterone blood test would cost about 55 to 60 euro in a private laboratory. The cost at the endocrinology laboratory at Mater Dei hospital is not known.