Luigi Selvaggi

N-acetyl-cysteine treatment improves insulin sensitivity in women with polycystic ovary syndrome.

OBJECTIVE To evaluate the effect of N-acetyl-cysteine (NAC) on insulin secretion and peripheral insulin resistance in subjects with polycystic ovary syndrome (PCOS). DESIGN Prospective data analysis. SETTING Volunteer women in an academic research environment. PATIENT(S) Six lean and 31 obese subjects, aged 19-33 years. INTERVENTION(S) Patients were treated for 5-6 weeks with NAC at a dose of 1.8 g/day orally. A dose of 3 g/day was arbitrarily chosen for massively obese subjects. Six of 31 obese patients with PCOS were treated with placebo and served as controls. MAIN OUTCOME MEASURE(S) Before and after the treatment period, the hormonal and lipid blood profile and insulin sensitivity, assessed by an hyperinsulinemic euglycemic clamp, were evaluated and an oral glucose tolerance test (OGTT) was performed. RESULT(S) Fasting glucose, fasting insulin, and glucose area under curve (AUC) were unchanged after treatment. Insulin AUC after OGTT was significantly reduced, and the peripheral insulin sensitivity increased after NAC administration, whereas the hepatic insulin extraction was unaffected. The NAC treatment induced a significant fall in T levels and in free androgen index values (P<.05). In analyzing patients according to their insulinemic response to OGTT, normoinsulinemic subjects and placebo-treated patients did not show any modification of the above parameters, whereas a significant improvement was observed in hyperinsulinemic subjects. CONCLUSION(S) NAC may be a new treatment for the improvement of insulin circulating levels and insulin sensitivity in hyperinsulinemic patients with polycystic ovary syndrome.

Metformin improves endothelial function in normoinsulinemic PCOS patients: a new prospective

BACKGROUND Metformin was reported to improve the alterations of endothelial reactivity in normal-weight subjects with polycystic ovary syndrome (PCOS). The aim of the present study was to investigate the mechanisms of action of this drug on the vascular function of this population. METHODS Thirteen normal-weight, normoinsulinemic and normolipemic PCOS women were studied before and after 6 months of metformin treatment (1000 mg/day). The endothelial function was assessed by evaluating the flow-mediated dilatation (FMD) of the brachial artery. We correlated this parameter with the endocrine-metabolic features of the patients. RESULTS Metformin significantly reduced testosterone (1.56 +/- 0.52 after 6 months versus 2.98 +/- 1.00 at baseline) and 17-hydroxyprogesterone (0.03 +/- 0.01 versus 0.06 +/- 0.02 nmol/ml) levels, without affecting gluco-insulinemic parameters. Concomitantly, the basal vessel diameter and the FMD significantly increased (4.12 +/- 0.68 versus 3.2 +/- 0.41 and 5.2 +/- 0.6 versus 3.76 +/- 0.5 mm, respectively), thus documenting an improved endothelial function. CONCLUSIONS Our data confirm the positive effects of metformin on the altered vascular reactivity, a precocious marker of cardiovascular risk, in normoinsulinemic PCOS subjects. This improvement seems to be mediated through hormonal changes, thus highlighting the detrimental role of hyperandrogenemia on the endothelial function, even beyond the metabolic factors. However, a direct effect of metformin on the endothelium should not be excluded.

Metformin effects on ovarian ultrasound appearance and steroidogenic function in normal-weight normoinsulinemic women with polycystic ovary syndrome: a randomized double-blind placebo-controlled clinical trial.

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.

Follicular loss in endoscopic surgery for ovarian endometriosis: quantitative and qualitative observations

OBJECTIVE To identify a possible marker of follicular depletion in relation to some histologic parameters of endometriotic cysts. DESIGN Prospective study. SETTING Università Cattolica del Sacro Cuore, Operative Division of Endocrinological Gynecology. PATIENT(S) Seventy-seven patients (aged 20-40 years) with endometrioma. INTERVENTION(S) Patients underwent laparoscopic surgery for ovarian endometriosis. MAIN OUTCOME MEASURE(S) After excision of the cyst wall, involuntarily removed follicles were correlated with age at surgery and with intrinsic histologic parameters of the specimen (thickness and composition of capsule; size of cyst). RESULT(S) There was a statistically significant relationship between patient age and number of follicles in the histologic section, a statistically significant inverse relationship between size of cyst and number of follicles, and no significant correlation between thickness of the capsule and number of follicles. Fibroblastic-type capsule, most frequently found in younger patients, was associated with removal of a significantly higher number of follicles. CONCLUSION(S) Our study suggests that patient age and cyst dimension are related to the histologic composition of the capsule, which is a marker of the aggressiveness of the cyst itself.

Could antispasmodic drug reduce pain during hysterosalpingo-contrast sonography (HyCoSy) in infertile patients? A randomized double-blind clinical trial

To assess the effectiveness of an antispasmodic drug, hyoscine‐N‐butylbromide, in reducing pain during hysterosalpingo‐contrast sonography (HyCoSy).

Telelap Alf-X–Assisted Laparoscopy for Ovarian Cyst Enucleation: Report of the First 10 Cases

This prospective single-institutional clinical trial sought to assess the safety and feasibility of laparoscopic benign ovarian cyst enucleation with a novel robotic-assisted laparoscopic system. Here we report a series of 10 patients treated using the Telelap ALF-X system in the first clinical application on patients at the Division of Gynecologic Oncology, Catholic University of the Sacred Heart of Rome. The primary inclusion criterion was the presence of monolateral ovarian cyst without a preoperative assessment suspicious for malignancy. Intraoperative data, including docking time, operative time, estimated blood loss, intraoperative and perioperative complications, and conversion to either standard laparoscopy or laparotomy, were collected. The cysts were removed with an ovary-sparing technique with respect to conservative surgical principles. The median operative time was 46.3 minutes, and patients without postoperative complications were discharged at 1 or 2 days after the procedure. Telelap ALF-X laparoscopic enucleation of benign ovarian cysts with an ovary-sparing technique is feasible, safe, and effective; however, more clinical data are needed to determine whether this approach can offer any other benefits over other minimally invasive surgical techniques.

Using a 16-French resectoscope as an alternative device in the treatment of uterine lesions: a randomized controlled trial

OBJECTIVE: To compare a 16-French resectoscope with a 22-French resectoscope and a 15-French hysteroscope for the treatment of uterine cavity lesions. METHODS: This was a prospective, randomized study of women with endometrial polyps or submucous myomas treated with a 16-French resectoscope, a traditional 22-French resectoscope, or a 15-French hysteroscope. The operating time, volume of distension medium delivered, discharge time, and patient discomfort by visual analog scale were recorded. Data were compared by one-way and two-way analysis of variance as appropriate. RESULTS: Four hundred one women were included in the analysis. All four parameters showed lower values in the 16-French resectoscope group (142 women) compared with the 15-French hysteroscope group (132 women; P<.01). The mean operating time was 10.87±2.87 minutes in the 22-French group (127 women), 8.33±2.94 minutes in the 16-French group, and 17.11±6.86 minutes in the 15-French group. The mean volume of distension medium delivered was 1,043±230 mL in the 22-French group, 991±442 mL in the 16-French group, and 1,489±566 mL in the 15-French group. The mean discharge time was 1.99±0.72 hours in the 22-French group, 1.08±0.18 hours in the 16-French group, and 1.89±0.68 hours in the 15-French group. Finally, the mean visual analog scale scores were 2.10±0.97 in the 22-French group, 1.93±1.03 in the 16-French group, and 4.00±1.61 in the 15-French group. An analysis of patients subdivided according to the lesion size (less than 1.5 cm and more than 1.5 cm in diameter) showed similar results. CONCLUSION: The new 16-French resectoscope is effective for the “see and treat” approach for both small (less than 1.5 cm diameter) and large (more than 1.5 cm diameter) uterine lesions. CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov, www.clinicaltrials.gov, NCT01430208. LEVEL OF EVIDENCE: I

Pituitary–ovarian response to the gonadotrophin-releasing hormone-agonist test in anovulatory patients with polycystic ovary syndrome: predictive role of ovarian stroma

Objective  To evaluate the influence of ovarian stroma on basal and poststimulus androgen secretion in patients affected by secondary amenorrhoea and polycystic ovaries (PCO) at ultrasound (US).

The effect of age on the ovarian response to gonadotropin and on pregnancy rate in polycystic ovary syndrome.

Recent studies have proposed that ,in women affected by the polycystic ovary syndrome (PCOS) ,aging is able to regularize the menstrual cyclicity. To evaluate the ovarian response in PCOS patients according to their age ,we studied 33 PCOS patients ,20 of whom with an age ranging from 28 to 34 years (younger PCOS) and 13 ranging from 35 to 45 years (older PCOS). All patients underwent an ovulation induction therapeutic protocol with low-dose recombinant follicle stimulating hormone ,for a total of 80 cycles (44 cycles for the younger PCOS group and 36 cycles for the older PCOS group). No significant difference was found between the days of therapy (12.3 ± 5.4 vs. 13.5 ± 5.6 days) ,total amount of drugs (980.7 ± 568.9 IU vs. 1063.9 ± 469.5 IU) or ovulation rate (93% vs. 89%) in the two groups. The two groups showed a significant difference in the maximum estradiol level (2053.5 ± 1497.2 vs. 1269.0 ± 911.5 pmol/l ,p < 0.01) ,the number of the recruited and preovulatory follicles (1.7 ± 2.5 vs. 0.64 ± 0.9 ,p < 0.05 and 1.7 ± 1.1 vs. 1.2 ± 0.5 ,p < 0.01 ,respectively) and the pregnancy rate (36% vs. 14% ,p < 0.05). In conclusion ,our data clearly showed that ,also in PCOS ,advanced age is a negative prognostic factor in the ovarian response to ovulation induction therapies.

Learning a new robotic surgical device: Telelap Alf X in gynaecological surgery

To assess the learning curve associated with tele‐assisted surgery.