ABSTRACT
OBJECTIVE: To compare the efficacy and safety of recombinant human FSH (r-hFSH) and hCG treatment for male hypogonadotropic hypogonadism (HH) in different populations and to identify characteristics predictive of spermatogenesis. DESIGN: A combined analysis of data from four clinical trials. SETTING: Phase III, open-label, noncomparative studies with similar designs conducted in Australia, Europe, Japan, and the United States. PATIENT(S): One hundred men with complete idiopathic or acquired HH. INTERVENTION(S): Pretreatment with hCG for 3-6 months, followed by combination therapy with hCG and r-hFSH (150 IU three times weekly) for up to 18 months. Doses of r-hFSH were adjusted according to spermatozoa count until the maximum dose was reached. MAIN OUTCOME MEASURE(S): The primary efficacy endpoint was a spermatozoa concentration of >or=1.5 x 10(6)/mL. RESULT(S): A total of 81 men remained azoospermic but achieved normal serum T concentrations after hCG pretreatment. Of these, 68 (84.0%) achieved spermatogenesis and 56 (69.1%) achieved spermatozoa concentrations >or=1.5 x 10(6)/mL. Large baseline mean testicular volume, low body mass index, and advanced sexual maturity were predictors of good response to therapy. Similar treatment responses were observed across different study populations. CONCLUSION(S): R-hFSH (combined with hCG) is effective for the restoration of fertility in the majority of men with HH.
Subject(s)
Chorionic Gonadotropin/administration & dosage , Follicle Stimulating Hormone/administration & dosage , Hypogonadism/diagnosis , Hypogonadism/drug therapy , Oligospermia/diagnosis , Oligospermia/drug therapy , Spermatogenesis/drug effects , Adolescent , Adult , Humans , Hypogonadism/complications , Male , Middle Aged , Oligospermia/complications , Prognosis , Recombinant Proteins/administration & dosage , Reproducibility of Results , Retrospective Studies , Sensitivity and Specificity , Sperm Count/methods , Treatment Outcome , Young AdultABSTRACT
OBJECTIVE: To assess whether ovarian volume of World Health Organization II anovulatory patients in the early follicular phase predicts the response to ovulation induction with gonadotropins. DESIGN: Retrospective data analysis of two prospective, randomized, multicenter studies. SETTING: Clinical development unit of biotechnology company. PATIENT(S): Four hundred sixty-five World Health Organization II anovulatory patients undergoing ovulation induction. MAIN OUTCOME MEASURE(S): Ovarian response to stimulation, ovulation (mid-luteal serum progesterone > 30 nmol/L), cancellation rate, pregnancy rate, and incidence of the ovarian hyperstimulation syndrome (OHSS) according to baseline ovarian volume (day 2-5) before stimulation. RESULT(S): Mean ovarian volume was 11.55 +/- 6.0 cm(3) (range, 0.8-49.3 cm(3)). Small ovarian volume was associated with lower rates of cycle cancellation owing to risk for OHSS (3 vs. 29 patients [2.8% vs. 9%]). Patients with small ovarian volume (<7.25 cm(3)) required fewer ampules of FSH (1373 IU vs. 1629 IU) and shorter duration of stimulation (16 vs. 18.1 days) and had higher ovulation rate than did patients with mid-range and larger ovarian volume (84.3% vs. 69.1% and 68.8%, respectively). The clinical pregnancy rate per cycle of hCG administration was similar in the three groups (25.8%, 28.1%, and 27.5%). CONCLUSIONS: World Health Organization II anovulatory women with medium-sized or large ovaries who are undergoing low-dose gonadotropin stimulation for ovulation induction may have higher risk for OHSS than do women with small ovaries. Women with small ovaries who meet criteria for administration of hCG respond better to ovulation induction and have a similar likelihood of conceiving compared with women with larger ovaries.
