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Romualdi D.,Catholic University of the Sacred Heart | Giuliani M.,Catholic University of the Sacred Heart | Cristello F.,Catholic University of the Sacred Heart | Fulghesu A.M.,University of Cagliari | And 4 more authors.
Fertility and Sterility

Objective: To investigate metformin effects on the endocrine-metabolic parameters and ovarian morphology in normoinsulinemic women with polycystic ovary syndrome (PCOS). Design: Randomized double-blind study. Setting: Operative Division of Endocrinological Gynecology, Università Cattolica del Sacro Cuore. Patient(s): Twenty-eight normal-weight normoinsulinemic PCOS women. Intervention(s): Patients were randomized to receive metformin 500 mg twice a day (group A, 15 subjects) or placebo (group B, 13 subjects) for 6 months. Ultrasonographic pelvic exams, hormonal and lipid features, and oral glucose tolerance test were performed at baseline and after 3 and 6 months of treatment. Main Outcome Measure(s): Hormonal and glycoinsulinemic assessment, ovarian ultrasound appearance. Result(s): Glycoinsulinemic assessment remained unvaried in both groups. About 70% of patients in group A experienced a restoration of menstrual cyclicity. Metformin significantly decreased testosterone levels at 3 and 6 months) and 17-hydroxyprogesterone levels at 6 months, and improved hirsutism score at 6 months. No clinical or hormonal modifications occurred in group B. Metformin, but not placebo, reduced ovarian volume and stromal/total area ratio at 3 and 6 months. Conclusion(s): Metformin seems to improve the menstrual pattern and ultrasonographic ovarian features in normoinsulinemic PCOS women. These effects seem to be, at least in part, independent of the insulin-lowering properties of the drug. © 2010 by American Society for Reproductive Medicine. Source

Sagnella F.,Catholic University of the Sacred Heart | Moro F.,Catholic University of the Sacred Heart | Lanzone A.,OASI Institute for Research | Tropea A.,Catholic University of the Sacred Heart | And 6 more authors.
Fertility and Sterility

Objective: To demonstrate the noninferiority of highly purified menotropin (HP-hMG) compared with recombinant FSH (rFSH) regarding clinical pregnancy rate (PR) in intrauterine insemination (IUI) cycles. Design: Prospective randomized noninferiority trial. Setting: Unit of physiopathology of human reproduction, university hospital. Patient(s): Five hundred twenty-three patients with unexplained infertility or mild male infertility undergoing controlled ovarian hyperstimulation for IUI. Intervention(s): Patients were randomized for treatment with rFSH (262 patients) or HP-hMG (261 patients). Insemination was performed 34-36 hours after hCG injection. Main Outcome Measure(s): The primary outcome was clinical pregnancy rate (PR). The secondary outcome was the number of interrupted cycles for high risk of ovarian hyperstimulation syndrome (OHSS) and multiple pregnancy. Result(s): The clinical PR was 19.7% (95% confidence interval [CI] 15.3%-25.1%) in the HP-hMG group and 21.4% (95% CI 16.9%-26.8%) in the rFSH group [absolute difference -1.7% (95% CI -8.6%-5.2%)]; therefore, the noninferiority was demonstrated. The number of interrupted cycles for OHSS risk and multiple pregnancy was significanty higher in the rFSH group, 8.4% (95% CI 5.6%-12.4%) than in the HP-hMG group 1.2% (95% CI 0.4%-3.3%) [absolute difference -7.27% (95% CI -11.3 to -3.7)]. Conclusion(s): HP-hMG is not inferior compared with rFSH regarding clinical PR. © 2011 American Society for Reproductive Medicine, Published by Elsevier Inc. Source

Fulghesu A.M.,University of Cagliari | Romualdi D.,Catholic University of the Sacred Heart | Di Florio C.,Catholic University of the Sacred Heart | Sanna S.,University of Cagliari | And 7 more authors.
Human Reproduction

STUDY QUESTIONDo different dosages of metformin account for different clinical and biochemical outcomes in women with polycystic ovary syndrome (PCOS) and do basal anthropometric and metabolic characteristics of the patients provide any indications regarding the dose required to reach the target effect? Summary answerDifferent doses of metformin exerted the same effects on clinical, biochemical and metabolic parameters in patients affected by PCOS. WHAT IS KNOWN AND WHAT THIS PAPER ADDSSince the insulin-sensitizing agents came into use in the management of PCOS, metformin has shown a positive benefitsrisks ratio. Nonetheless, therapeutic schedules are not well standardized. This is the first study which systematically analyses the effect of different doses of metformin on clinical, hormonal and metabolic features of PCOS. On the basis of our results, higher doses are no more effective than lower doses. DESIGNA multicentric cohort prospective study. A total of 250 PCOS women were enrolled, 49 lost to follow-up. Menstrual cyclicity, hormonal assays, oral glucose tolerance test, lipid profile and ultrasonographic pelvic examination were evaluated at the baseline and after 6 months of metformin treatment at different doses (1000, 1500 and 1700 mg). PARTICIPANTS AND SETTINGA total of 201 PCOS patients completed the study without protocol violations in three university hospitals: seventy-three patients from Centre A (treated with metformin 500 mg twice a day), 60 patients from Centre B (treated with metformin 500 mg three times a day) and 68 patients from Centre C (treated with metformin 850 mg twice a day). MAIN RESULTS AND THE ROLE OF CHANCEMetformin exerted an overall positive effect on the clinical and endocrine-metabolic features of PCOS. The degree of these effects was independent of the administered dosage in every range of basal body mass index (BMI). When patients were stratified according to their insulinaemic status, scattered inter-doses differences were found in some of the outcome measures. Patients who exhibited an increase of >2 menstrual cycles/year were considered as responders to treatment. Responders had a higher basal BMI than non-responders and showed a greater reduction in plasma testosterone levels after metformin treatment, but other outcome measures did not differ significantly. Total insulin secretion in the 180 min following the glucose tolerance test before metformin treatment (basal AUC-I) was significantly correlated with the decrease in insulin secretion induced by metformin in both the whole group and in responders, but only correlated with the variation in the number of cycles in responders. BIAS, CONFOUNDING AND OTHER REASONS FOR CAUTIONThe different doses were administered in different centres, and between-centre variation is a potential confounding factor. GENERALIZABILITY TO OTHER POPULATIONSThe paradigm of using the minimum effective dose of metformin could be pursued in other pathological conditions characterized by insulin resistance. STUDY FUNDING/COMPETING INTEREST(S)No funding or competing interests to declare. © 2012 The Author. Source

Villa P.,Catholic University of the Sacred Heart | Rossodivita A.,Catholic University of the Sacred Heart | Sagnella F.,Catholic University of the Sacred Heart | Moruzzi M.C.,Catholic University of the Sacred Heart | And 5 more authors.
Clinical Endocrinology

Objective To evaluate the role of mean ovarian volume (MOV) in the diagnosis of polycystic ovary syndrome (PCOS) during adolescence, and its relationship with metabolic and endocrine parameters. Design Observational study. Patients A total of 134 young girls, including 86 adolescents with PCOS and 48 controls, were studied. Measurements During the early follicular phase, a pelvic ultrasound examination was performed to measure the ovarian volume of both ovaries and to calculate the MOV. All subjects underwent hormonal assessment and an ultrasound examination. PCOS subjects were submitted to an oral glucose tolerance test. The homeostasis model assessment for insulin resistance (HOMA-IR) and several insulin resistance indexes were also determined. Results Androgens, free androgen index (FAI), LH and insulin resistance indexes were higher in the PCOS group. MOV was significantly different between the two groups: control group 4·6 ± 1·9 cm3, adolescent PCOS group 9·6 ± 4·4 cm 3. The MOV threshold of 5·596 cm3 offered the best compromise between sensitivity and specificity based on the characteristics of the operating receiver curve analysis. Therefore, an ovarian volume higher than 5·6 increased the risk of PCOS by about 15 times (OR 16·25 IC 95% 6·3-41·3). In adolescent PCOS girls, the ovarian volume was significantly associated with circulating testosterone and insulin, and indices of insulin resistance. Conclusions During early adolescence MOV evaluation may offer an effective means to screen and follow up young girls with irregular cycles in order to prevent the long-term metabolic disturbances of the polycystic ovary syndrome. © 2012 Blackwell Publishing Ltd. Source

Romualdi D.,Catholic University of the Sacred Heart | De Cicco S.,Catholic University of the Sacred Heart | Gagliano D.,Catholic University of the Sacred Heart | Busacca M.,Catholic University of the Sacred Heart | And 4 more authors.
Diabetes Care

OBJECTIVE - Metformin has been reported to reduce the risk of gestational diabetes (GD) in women with polycystic ovarian syndrome (PCOS). However, little is known about the mechanisms of action of this drug during pregnancy. In the attempt to fill this gap, we performed a prospective longitudinal study providing a detailed examination of glucose and insulin metabolism in pregnant women with PCOS undergoing metformin therapy. RESEARCH DESIGN AND METHODS - We enrolled 60 women with PCOS who conceived while undergoing metformin treatment. An oral glucose tolerance test and a uglycemic-hyperinsulinemic clamp were performed at each trimester of gestation in 47 ongoing pregnancies. RESULTS - Twenty- two of the study subjects had development of GD despite the treatment. At baseline, insulin sensitivity was comparable between women who had development of GD and women who did not. A progressive decline in this parameter occurred in all subjects, independently of the trimester of GD diagnosis. Insulin secretion was significantly higher during the first trimester in patients with an early failure of metformin treatment. Women with third trimester GD and women with no GD exhibited a significant increase in insulin output as gestation proceeded. All newborns were healthy and only one case of macrosomia was observed. CONCLUSIONS - Women with PCOS who enter pregnancy in a condition of severe hyperinsulinemia have development of GD earlier, independently of metformin treatment. The physiologic deterioration of insulin sensitivity is not affected by the drug and does not predict the timing and severity of the glycemic imbalance. Despite the high incidence of GD observed, the drug itself or the intensive monitoring probably accounted for the good neonatal outcome. © 2013 by the American Diabetes Association. Source

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