A total of 750 infertile women 18 to 40 years of age with the polycystic ovary syndrome who had no major medical disorders and who were not taking confounding medications (primarily sex steroids, other infertility drugs, and insulin sensitizers, as described in the study protocol), their male partners, and their neonates participated in the study.9 (link) We used modified Rotterdam criteria1 to diagnose the polycystic ovary syndrome. Accordingly, all participating women had ovulatory dysfunction combined with hyperandrogenism (on the basis of hirsutism9 (link) or an elevated testosterone level10 (link)), polycystic ovaries (defined by an increased number of small antral follicles [≥12 follicles that were <10 mm in diameter] or an increased individual ovarian volume [>10 cm3] in ≥1 ovary), or both.9 (link) Other disorders that mimic the polycystic ovary syndrome, including thyroid disease and prolactin excess, were ruled out.
Additional eligibility criteria were at least one patent fallopian tube and a normal uterine cavity, as determined by sonohysterography (on the basis of the presence of free fluid in the pelvis), hysterosalpingography, a combined hysteroscopy and laparoscopy, or evidence of an intrauterine pregnancy within the previous 3 years; a male partner with a sperm concentration of at least 14 million per milliliter, with documented motility according to World Health Organization cutoff points,11 (link) in at least one ejaculate during the previous year; and a commitment on the part of the women and their partners to have regular intercourse during the study with the intent of pregnancy.
Additional eligibility criteria were at least one patent fallopian tube and a normal uterine cavity, as determined by sonohysterography (on the basis of the presence of free fluid in the pelvis), hysterosalpingography, a combined hysteroscopy and laparoscopy, or evidence of an intrauterine pregnancy within the previous 3 years; a male partner with a sperm concentration of at least 14 million per milliliter, with documented motility according to World Health Organization cutoff points,11 (link) in at least one ejaculate during the previous year; and a commitment on the part of the women and their partners to have regular intercourse during the study with the intent of pregnancy.