Development and validation of a questionnaire for assessing androgen deficiency in women (FAD - Female Androgen Deficiency) of reproductive age

Relevance: The early manifestations of androgen deficiency begin in women after the age of 35, particularly in infertile patients with diminished ovarian reserve (DOR). Their detection can be used in clinical practice to assess the degree of androgen deficiency and to predict possible outcomes of assisted reproductive technology (ART) (IVF/ICSI) programs. Objective: To develop and validate a Female Androgen Deficiency (FAD) questionnaire for assessing androgen def iciency in infertility women for f urther use in clin ical practice. Materials and methods: We developed the FAD questionnaire in accordance with international and Russian standards and tested it with a focus group of women with presumed androgen deficiency including infertile women with diminished ovarian reserve. After that we assessed the results of psychometric testing including reliability, validity and sensitivity of the developed questionnaire. Results: The results of FAD testing with the participation of patients and expert clinical opinion confirmed the acceptability of the FAD questionnaire, its compliance with the environment, and high indicators of content and external validity. The stable structure of the instrument was shown, indicating satisfactory construct validity of the questionnaire. The a-Cronbach's coefficient was equal to 0.837, indicating the internal consistency of the FAD questionnaire. An analysis of the correlations between the total FAD score and the number of symptoms in infertile women with DOR revealed a statistically significant strong negative relationship (r=-0.76; p<0.001), which reflects good criterion validity. The factor analysis showed the adequacy of the questionnaire's factor structure according to the relationships between variables and its stable construct validity. The total quality of life score on the questionnaire was lower in healthy women than in women with DOR [31.7(6.2) vs 18.4 (4.1)], demonstrating satisfactory discriminant validity of the questionnaire. The correlation analysis of the FAD and FSFI showed satisfactory convergent validity of the FAD questionnaire. Conclusion: The study results testify to the reliability, validity, and sensitivity of the FAD questionnaire and its use for both clinical practice and for scientific purposes in obstetrics and gynecology, in particular, gynecological endocrinology and reproductive medicine.

FAD, androgens, androgen def iciency, reproductive age, infertility, decreased ovarian reserve, questionnaire, validation, FAD