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Design of studies for the assessment of drugs and hormones used in the treatment of endocrine forms of female infertility.
In: Diczfalusy, E., ed. Regulation of human fertility. (Proceedings of the WHO Symposium on Advances in Fertility Regulation, Moscow, USSR, November 16-19, 1976) Copenhagen, Denmark, Scriptor, 1977. p. 135-154The lack of uniformity in diagnostic selection of women for treatment of infertility, in choice of therapy, in monitoring of therapy, and in follow-up, frequently does not allow a meaningful comparison of results reported from different centers. To design studies assessing effectiveness of therapy of endocrine forms of female infertility, it is essential to consider: 1) mechanism controlling reproductive functions (e.g., process of ovulation); 2) cause(s) responsible for infertility (mechanical factors, ovarian failure, and pituitary failure); and 3) the mechanism of action of agents used for therapy (e.g., gonadotropins stimulate gonadal function, clomiphene stimulates gonadotropin secretion, and ergoline derivatives inhibit prolactin secretion). Patients selected for therapy should be grouped according to etiology: 1) hypothalamic-pituitary failure; 2) hypothalamic-pituitary dysfunction; 3) ovarian failure; 4) congenital or acquired genital tract disorder; 5) hyperprolactinemic patients with a space-occupying lesion in the hypothalamic-pituitary region; 6) hyperprolactinemic patients with no space-occupying lesion; and 7) amenorrheic women with space-occupying lesion. Ideally, an infertile couple should be diagnosed and treated as a unit.