Pasquale De Franciscis

Hysteroscopic resection of the septum improves the pregnancy rate of women with unexplained infertility: a prospective controlled trial.

OBJECTIVE To assess fecundity of infertile women after surgical correction of uterine septum. DESIGN Prospective controlled trial. SETTING Three academic infertility clinics. PATIENT(S) Forty-four women affected by septate uterus and otherwise unexplained infertility represented the study group (group A), and 132 women with unexplained infertility were enrolled as control subjects (group B). INTERVENTION(S) Hysteroscopic metroplasty was performed in group A, and group B was managed expectantly. All women were followed-up for 1 year without any other intervention. MAIN OUTCOME MEASURE(S) Fecundity rate was calculated as the number of pregnancies per 100 person-months. RESULT(S) Pregnancy rate (38.6% vs. 20.4%) and live birth rate (34.1% and 18.9%) were significantly higher in group A than in group B. The survival analysis showed that the probability of a pregnancy in the twelve-months follow up was significantly higher in patients who had undergone metroplasty than in women with unexplained infertility. The corresponding fecundity (10-week pregnancy) rates were 4.27 and 1.92 person-months in women who had undergone metroplasty and in women with unexplained infertility, respectively. CONCLUSION(S) Hysteroscopic resection of the septum improves fecundity of women with septate uterus and otherwise unexplained infertility. Patients with septate uterus and no other cause of sterility have a significantly higher probability of conceiving after removal of the septum than patients affected by idiopathic sterility.

Effects of different types of hormone replacement therapy on mammographic density

OBJECTIVES to evaluate the effects of different types of hormone replacement therapy (HRT) on mammographic density in postmenopausal women. METHODS In a prospective 1-year study, 121 healthy postmenopausal women were allocated to one of the following five study groups: twenty-six women were treated with continuous transdermal 17beta-estradiol 50 mcg/die plus acetate nomegestrolo 5 mg/die sequentially added for 12 days per month (Group A); 25 women were treated with continuous transdermal 17beta-estradiol 50 mcg/die plus acetate nomegestrolo 2.5 mg/die added every day (Group B); 23 women were treated with continuous transdermal 17beta-estradiol 50 mcg/die (Group C); 24 women were treated with tibolone 2.5 mg/die (Group D); and 23 women not receiving any medication represented the control group (Group E). At the time of recruitment and after 12 months a two-view mammography was performed to evaluate mammographic density according to a quantitative method: type 1 (less than 25% of mammary gland covered by dense tissue), type 2 (from 25 to 75% of total glandular area covered by dense tissue), type 3 (more than 75% of mammary parenchyma covered by dense tissue). RESULTS After 12 months of HRT, seven out of 20 patients (35%) in group A, nine of 21 patients (42.85%) in group B, four out of 19 patients (21%) in group C and two of 20 patients (10%) in group D, showed an increase in mammographic density. No variation of density was observed at the second mammographic test in the control group. The mammographic density increase which occurred in groups A, B and C was statistically significant (P<0.05) when compared with group E; no statistically significant difference (P=0.49) was found in mammographic density increase between group D and group E. When the different treatment types were compared each other, a statistically significant difference (P=0.04) was found only between the mammographic density increase occurring in groups B and D. CONCLUSIONS HRT may cause an increase of mammographic density. The frequency of the density increase is related to the type of HRT and a replacement therapy including a progestin, especially in continuous combination with estrogen, leads to more evident mammographic changes. Tibolone does not significantly affect mammographic density.

Effects of tibolone on the breast

OBJECTIVE to evaluate the effect of hormone replacement therapy and tibolone on the breast. STUDY DESIGN prospective, controlled, randomized study. SETTING Outpatient Menopause Clinic of the Second University of Naples. PARTICIPANTS forty four women in spontaneous menopause without any risk factor for breast cancer were randomly allocated to three groups: 15 patients (group A) were treated with transdermal oestrogens 50 microg, 2 patches/week for 3 weeks per month, plus acetate nomegestrolo per os 5 mg/die for 12 days per cycle, 17 patients (group B) were treated with tibolone 2.5 mg/die. Twelve patients not given any medication represented the control group (group C). METHODS at the time of recruitment and after at least 12 months of therapy the patients were subjected to a questionnaire aimed at quantifying the slight, moderate or severe presence of the tension/mastodynia symptoms and to a mammographic test to assess the parenchymal pattern according to a quantitative method: type 1 (less than 25% of mammary gland covered by dense tissue), type 2 (from 25% to 75% of total glandular area covered by dense tissue), type 3 (more than 75% of mammary parenchyma covered by dense tissue). Statistical analysis was carried out by means of Fishers exact test. RESULTS after at least 12 months of treatment in Group A 5 out of 15 patients (33%) showed a trend of increase in mammographic density not statistically significant (P=0.22) when compared with group B in which one patient showed a swift from type 1 to type 2 and another from type 2 to type 3. The analysis of tension/mastodynia symptoms revealed a significantly difference between the two groups (P=0.02): in group A mastodynia appeared in three previously asymptomatic women and increased in five women, with a total increase in the symptomatology in 8 out of 15 patients (53.3%), in group B only in one case (5%) mastodynia turned from slight to moderate. CONCLUSION in postmenopausal women oestroprogestogenic replacement therapy may be associated with an increase in mammographic density and with the onset or increase in mastodynia. On the contrary tibolone does not seem to affect normostructured mammas and may be considered a first-rate replacement therapy in case of mammas showing particular density or benign mastopathies.

Effects of a short-term suspension of hormone replacement therapy on mammographic density

OBJECTIVE To evaluate the effects of hormone replacement therapy (HRT) and of a short-term suspension of HRT on mammographic density. DESIGN Prospective clinical study. SETTING Outpatient menopausal clinic of the Second University of Naples. PATIENT(S) Ninety-seven healthy postmenopausal women. INTERVENTION(S) Thirty-nine menopausal women with intact uterus (group A) were treated with continuous transdermal E(2) plus acetate nomegestrolo sequentially added, 37 women in surgical menopause (group B) were treated with transdermal E(2) continuously administered, and 21 menopausal women did not receive any medication (group C). At the entry and after 12 months, a mammography was performed without suspension of HRT (group A1: 19 women; group B1: 19 women) or after a short-term suspension (group A2: 20 women; group B2: 18 women). MAIN OUTCOME MEASURE(S) Mammographic density evaluated according to a quantitative method. RESULT(S) At the second mammography, seven patients in group A1, four patients in group B1, and one patient in both groups A2 and B2 showed an increase in mammographic density, whereas no mammographic density increase was observed in patients in group C. A statistically significant difference in the mammographic density increase was found between group A1 and group A2; no difference was found between group B1 and B2. CONCLUSION(S) Suspension of HRT for about 3 weeks may reverse mammographic density increase associated with its use.

Long-term effects of oral and transdermal hormone replacement therapy on plasma homocysteine levels.

ObjectiveTo compare the long-term effects of oral and transdermal hormone replacement therapy (HRT) on serum homocysteine levels in postmenopausal women. DesignAn open, prospective, controlled study. Seventy-five healthy postmenopausal women were recruited as eligible for the study. Fifty women seeking HRT were randomized to receive continuous 17&bgr;-estradiol, either by oral (2 mg daily; n = 25) or transdermal (50 &mgr;g daily; n = 25) administration, plus 10 mg dydrogesterone daily for 14 days of each 28-day cycle. Twenty-five women unwilling to receive hormone treatment received only calcium supplementation, representing the control group. Fasting blood samples were analyzed at baseline and then after 6, 12, and 24 months to determine plasma homocysteine levels. ResultsFifty-nine women completed the study. After 6 months of therapy, homocysteine concentrations showed a statistically significant reduction in the treated groups versus both baseline and controls, and no further significant variations were found thereafter. The mean reduction in the homocysteine levels throughout the study was 13.6% in the oral and 8.9% in the transdermal group, respectively, without significant difference between the two routes of estradiol administration. Women with the highest baseline levels of homocysteine experienced the greatest reduction. No significant variations in homocysteine concentrations were found in the control group. ConclusionsOral and transdermal estradiol sequentially combined with dydrogesterone shows comparable effectiveness in reducing plasma homocysteine levels in postmenopausal women. Women with the highest pretreatment concentrations of homocysteine benefit the most by the lowering effect of HRT.

Effectiveness of the association micronized N-Palmitoylethanolamine (PEA)–transpolydatin in the treatment of chronic pelvic pain related to endometriosis after laparoscopic assessment: a pilot study

OBJECTIVE Aim of our study was to evaluate the effectiveness of the association between N-Palmitoylethanolamine and transpolydatin in the management of chronic pelvic pain related to EMS. STUDY DESIGN This was a randomized, double-blind, parallel-group, placebo-controlled clinical trial involving 61 subjects, submitted to a first line laparoscopic conservative surgery, who were randomized into 3 groups receiving: group A (n=21) the association N-Palmitoylethanolamine-transpolydatin 400 mg + 40 mg twice a day for 3 months; group B (n=20) the placebo for 3 months; group C (n=20) a single course of Celecoxib 200mg twice a day for 7 consecutive days. Assessments of the severity of pelvic endometriosis (pelvic pain, dysmenorrhoea and dyspareunia) were recorded before and after treatment on a questionnaire and a 10-point VAS. Differences between groups were verified with Kruskal-Wallis ANOVA for non-parametric multiple comparisons. RESULTS A marked decrease in dysmenorrhoea, dyspareunia and pelvic pain was observed in all groups, and the association between N-Palmitoylethanolamine and transpolydatin resulted to be more effective than placebo (P<.001). Additionally, the treatment with Celecoxib resulted in a decrease in pelvic pain more effective either than the association N-Palmitoylethanolamine and transpolydatin or placebo. CONCLUSION These preliminary results show that the association between micronized N-Palmitoylethanolamine and transpolydatin is effective in the management of pelvic pain related to endometriosis after laparoscopy. Additionally, this association seems to be safe, shows an optimal control of pain and can be used in patients who are unable to receive other therapies.

Recombinant Human FSH Reduces Sperm DNA Fragmentation in Men With Idiopathic Oligoasthenoteratozoospermia

A prospective randomized controlled study was designed to evaluate the effects of recombinant human follicle-stimulating hormone (rFSH) treatment on sperm DNA fragmentation in men with idiopathic oligoasthenoteratozoospermia (iOAT). One hundred twenty-nine men with sperm count less than 10 × 10(6) spermatozoa/mL and forward motility <25% were included; normal serum levels of FSH, luteinizing hormone (LH), and testosterone, and no other causes of infertility were enrolled. The patients were randomized into 2 groups: 65 men were treated on alternate days for 90 days with injections of 150 IU rFSH, and 64 subjects received nonantioxidant vitamin supplements. Main outcome measures were serum levels of FSH, LH, testosterone, and inhibin B and DNA fragmentation index (DFI) at baseline and after 90 days. No significant differences were observed between the 2 groups with regard to sperm parameters and hormone values. The DFI was similar between the 2 groups at the time of the enrollment but reduced significantly (P < .05) after rFSH therapy in study group, whereas no significant variation occurred in the control group. In the subgroup of patients with high basal DFI values (>15%), rFSH treatment significantly increased DFI (P < .01), whereas no significant variation occurred after 90 days of vitamin supplements. We conclude that rFSH administration improves sperm DNA integrity in iOAT men with increased DFI values. The degree of sperm DFI might be useful to identify those iOAT patients in which rFSH treatment can be advantageous.

Raloxifene slows down the progression of intima-media thickness in postmenopausal women.

Objective:To investigate the effect of raloxifene on atherosclerosis progression in healthy postmenopausal women. Design:In a prospective fashion, a total of 155 healthy postmenopausal women were randomly assigned to receive raloxifene 60 mg/day or a matching placebo for 18 months. Atherosclerosis progression was evaluated by B-mode ultrasonography measuring the intima-media thickness (IMT) of the carotid arteries. Plasma levels of triglycerides, low-density lipoprotein cholesterol, soluble forms of intercellular adhesion molecule-1 and vascular cell adhesion molecule-1, E-selectin, interleukin-6, tumor necrosis factor &agr;, adiponectin, and the degree of insulin resistance by the homeostatic model assessment method were also determined. Results:The progression slope of carotid IMT was 0.0112 mm/18 months in the raloxifene group and 0.0857 mm/18 months in the placebo group (P < 0.004). Raloxifene treatment compared with placebo produced a significant decrease in plasma triglycerides (P < 0.02), low-density lipoprotein cholesterol (P < 0.02), soluble forms of intercellular adhesion molecule-1 (P < 0.005) and vascular cell adhesion molecule-1 (P < 0.04), E-selectin (P < 0.02), interleukin-6 (P < 0.005), tumor necrosis factor &agr; (P < 0.005) levels, and homeostatic model assessment index (P < 0.005) and a significant increase in plasma adiponectin levels (P < 0.001). Logistic regression analysis indicated that women receiving raloxifene had a lower risk of IMT progression (odds ratio = 0.41; 95% CI: 0.32-0.70). Conclusion:Raloxifene treatment, possibly through an increase in plasma adiponectin levels, may slow the progression of IMT in postmenopausal women.

In vitro fertilization following laparoscopic ovarian diathermy in patients with polycystic ovarian syndrome

Background. To evaluate the in vitro fertilization outcome in patients with polycystic ovarian syndrome previously treated by laparoscopic ovarian diathermy.

The significance of hysteroscopic treatment of congenital uterine malformations

Hysteroscopic surgery replaced abdominal metroplasty and is today the treatment of choice for congenital uterine malformations. This is not just because of its reproductive results, which are comparable to those achieved with the abdominal approach, but mainly because of several post-operative benefits (reduced morbidity, convalescence and costs, and no scar tissue on the abdominal and uterine walls), improved reproductive performance (no reduction in uterine volume, shorter interval to conception after operation) and the mode of delivery (avoiding Caesarean section). Decisions on when and how to treat uterine septa, in relation to the type of malformation, are discussed. In particular, indications for treatment have been broadened to include not only the septate uterus associated with adverse reproductive outcome, but also patients before any potential obstetric accidents, especially in those with declining fecundity (>35 years), with reproductive problems (unexplained infertility) and before assisted reproductive techniques, as well as in women with no actual desire of pregnancy. Two types of hysteroscopic treatment are available: resectoscopic and office hysteroscopic surgery. The indications for resectoscopic surgery are broad-based septa and complete septa with single or double cervix. The resectoscope allows an excellent continuous flow system, providing continuous washing of the uterine cavity and a clear view, removing bubbles and debris during the procedure. However, an exact measurement of fluid balance must be performed to avoid excessive fluid intravasation. Laparoscopic or sonographic monitoring is mandatory. Treatment of limited-based small septa whose apex is easily visible can be achieved with an outpatient approach using office mini-hysteroscopic surgery and the vaginoscopic technique. The intra-operative check of the fundus is performed by ultrasonography. No preparation of the endometrium is required, except for large, broad-based septa, and hormonal therapy and intrauterine devices are not utilized post-operatively. The post-operative follow-up consists of a hysteroscopic check performed 1-3 months after surgery.