Attilio Di Spiezio Sardo

The ESHRE/ESGE consensus on the classification of female genital tract congenital anomalies

STUDY QUESTION What classification system is more suitable for the accurate, clear, simple and related to the clinical management categorization of female genital anomalies? SUMMARY ANSWER The new ESHRE/ESGE classification system of female genital anomalies is presented. WHAT IS KNOWN ALREADY Congenital malformations of the female genital tract are common miscellaneous deviations from normal anatomy with health and reproductive consequences. Until now, three systems have been proposed for their categorization but all of them are associated with serious limitations. STUDY DESIGN, SIZE AND DURATION The European Society of Human Reproduction and Embryology (ESHRE) and the European Society for Gynaecological Endoscopy (ESGE) have established a common Working Group, under the name CONUTA (CONgenital UTerine Anomalies), with the goal of developing a new updated classification system. A scientific committee (SC) has been appointed to run the project, looking also for consensus within the scientists working in the field. PARTICIPANTS/MATERIALS, SETTING, METHODS The new system is designed and developed based on (i) scientific research through critical review of current proposals and preparation of an initial proposal for discussion between the experts, (ii) consensus measurement among the experts through the use of the DELPHI procedure and (iii) consensus development by the SC, taking into account the results of the DELPHI procedure and the comments of the experts. Almost 90 participants took part in the process of development of the ESHRE/ESGE classification system, contributing with their structured answers and comments. MAIN RESULTS AND THE ROLE OF CHANCE The ESHRE/ESGE classification system is based on anatomy. Anomalies are classified into the following main classes, expressing uterine anatomical deviations deriving from the same embryological origin: U0, normal uterus; U1, dysmorphic uterus; U2, septate uterus; U3, bicorporeal uterus; U4, hemi-uterus; U5, aplastic uterus; U6, for still unclassified cases. Main classes have been divided into sub-classes expressing anatomical varieties with clinical significance. Cervical and vaginal anomalies are classified independently into sub-classes having clinical significance. LIMITATIONS, REASONS FOR CAUTION The ESHRE/ESGE classification of female genital anomalies seems to fulfill the expectations and the needs of the experts in the field, but its clinical value needs to be proved in everyday practice. WIDER IMPLICATIONS OF THE FINDINGS The ESHRE/ESGE classification system of female genital anomalies could be used as a starting point for the development of guidelines for their diagnosis and treatment. STUDY FUNDING/COMPETING INTEREST(S) None.

Effectiveness of auto-crosslinked hyaluronic acid gel in the prevention of intrauterine adhesions after hysteroscopic surgery: a prospective, randomized, controlled study.

BACKGROUND A prospective, randomized, controlled study was performed to assess the efficacy of auto-crosslinked hyaluronic acid (ACP) gel to prevent the development of de-novo intrauterine adhesions following hysteroscopic surgery. METHODS One hundred and thirty-two patients with a single surgically remediable intrauterine lesion (myomas, polyps and uterine septa, subgroups I-III) completed the study. Patients were randomized to two different groups: group A underwent hysteroscopic surgery plus intrauterine application of ACP gel (10 ml) while group B underwent hysteroscopic surgery alone (control group). The rate of adhesion formation and the adhesion score was calculated for each group and subgroup 3 months after surgery. RESULTS Group A showed a significant reduction in the development of de-novo intrauterine adhesions at 3 months follow-up in comparison with the control group. Furthermore, the staging of adhesions showed a significant decrease in adhesion severity in patients treated with ACP gel. CONCLUSIONS ACP gel significantly reduces the incidence and severity of de-novo formation of intrauterine adhesions after hysteroscopic surgery.

Effects of hormone replacement therapy on ocular function in postmenopause.

ObjectiveTo evaluate the effect of hormone replacement therapy on climacteric ocular complaints, lacrimal secretion, intraocular pressure (IOP), and corneal thickness. DesignA prospective, controlled, randomized study on 50 healthy women (mean age 53.4 ± 3.8 years) at least 1 year after spontaneous menopause. Twenty-five women (group A) were treated with transdermal 17&bgr;-estradiol (50 &mgr;g/day) and medroxyprogesterone acetate (10 mg/day) for 12 days per cycle. Twenty-five untreated women (group B) were used as a control group. All participants underwent eye examination at the beginning of the study and after 3 and 6 months of therapy to detect ocular diseases and to measure lachrymal secretion, IOP, and corneal thickness. ResultsNo significant differences were observed between the two groups at the beginning of the study. After 3 and 6 months of treatment, we observed a significant reduction in the percentage of women in group A affected by ocular symptoms and in the severity of symptomatology in comparison with baseline and with group B (P < 0.01). A significant increase of both basal and stimulated lachrymal secretion was observed after 3 months of therapy in group A in comparison with baseline (P < 0.01). There was a significant decrease of IOP (P < 0.01) after 3 months of therapy in group A (P < 0.01), and a slight, nonsignificant increase of corneal thickness was observed in group A at 3 and 6 months in comparison with basal values. ConclusionOur data suggest that hormone replacement therapy may exert a beneficial effect on ocular symptomatology, increase lachrymal secretion, reduce IOP, and increase corneal thickness.

Review of New Office-Based Hysteroscopic Procedures 2003–2009

Office operative hysteroscopy is a recent technique that enables treatment of uterine pathologic disorders in the ambulatory setting using miniaturized hysteroscopes with mechanical or electric instruments. The available international literature from 1990 to 2002 has clearly demonstrated that such technique enables performance of hysteroscopically directed endometrial biopsy and treatment of uterine adhesions, anatomic disorders, polyps, and small myomas safely and successfully without cervical dilation and the need for anesthesia. This review provides a comprehensive survey of further advancements of office operative hysteroscopy in the treatment of other gynecologic pathologic conditions that have not been included in the schema of treatment indications for office procedures proposed in 2002. A search of MEDLINE, EMBASE, and the Cochrane Database of Systematic Reviews identified articles published from 2003 to 2009. Eighteen articles were identified: 9 on hysteroscopic sterilization; 1 on office-based metroplasty, 8 on office-based treatment of some uncommon gynecologic pathologic conditions (e.g., hematometra, diagnosis and treatment of vaginal lesions, treatment of uterine cystic neoformations, bleeding from the cervical stump, diagnosis and treatment of endocervical ossification, and removal of uterovaginal packing). All performed procedures were carried out safely and successfully in the office setting, with high patient tolerance and minimal discomfort. The success of the procedures has been confirmed by resolution of symptoms and at follow-up ultrasonographic and hysteroscopic examinations. Currently, as a result of technologic advancements and increased operator experience, an increasing number of gynecologic pathologic conditions traditionally treated in the operating room may be treated safely and effectively using office operative hysteroscopy.

The ESHRE–ESGE consensus on the classification of female genital tract congenital anomalies

The new ESHRE/ESGE classification system of female genital anomalies is presented, aiming to provide a more suitable classification system for the accurate, clear, correlated with clinical management and simple categorization of female genital anomalies. Congenital malformations of the female genital tract are common miscellaneous deviations from normal anatomy with health and reproductive consequences. Until now, three systems have been proposed for their categorization, but all of them are associated with serious limitations. The European Society of Human Reproduction and Embryology (ESHRE) and the European Society for Gynaecological Endoscopy (ESGE) have established a common Working Group, under the name CONUTA (CONgenital UTerine Anomalies), with the goal of developing a new updated classification system. A scientific committee has been appointed to run the project, looking also for consensus within the scientists working in the field. The new system is designed and developed based on: (1) scientific research through critical review of current proposals and preparation of an initial proposal for discussion between the experts, (2) consensus measurement among the experts through the use of the DELPHI procedure and (3) consensus development by the scientific committee, taking into account the results of the DELPHI procedure and the comments of the experts. Almost 90 participants took part in the process of development of the ESHRE/ESGE classification system, contributing with their structured answers and comments. The ESHRE/ESGE classification system is based on anatomy. Anomalies are classified into the following main classes, expressing uterine anatomical deviations deriving from the same embryological origin: U0, normal uterus; U1, dysmorphic uterus; U2, septate uterus; U3, bicorporeal uterus; U4, hemi-uterus; U5, aplastic uterus; U6, for still unclassified cases. Main classes have been divided into sub-classes expressing anatomical varieties with clinical significance. Cervical and vaginal anomalies are classified independently into sub-classes having clinical significance. The ESHRE/ESGE classification of female genital anomalies seems to fulfil the expectations and the needs of the experts in the field, but its clinical value needs to be proved in everyday practice. The ESHRE/ESGE classification system of female genital anomalies could be used as a starting point for the development of guidelines for their diagnosis and treatment.

Effects of an oral contraceptive containing drospirenone on bone turnover and bone mineral density.

OBJECTIVE: To compare the effects of a new 21-day combined oral contraceptive containing 30 μg ethinyl/estradiol plus 3 mg drospirenone with a 21-day preparation containing 30 μg ethinyl/estradiol plus 75 μg gestodene on bone turnover and bone mineral density in young fertile women. METHODS: A randomized, controlled trial was conducted with healthy fertile women treated with 30 μg ethinyl/estradiol plus 3 mg drospirenone (group A; n = 24), 30 μg ethinyl/estradiol plus 75 μg gestodene (group B; n = 24) and healthy controls (group C, n = 23). At 3, 6, 9, and 12 months of the study, serum and urinary calcium, osteocalcin, urinary pyridinoline, and deoxypyridinoline were measured. At baseline and after 12 months, lumbar bone mineral density was determined by dual-energy X-ray absorptiometry. RESULTS: In groups A and B, urinary pyridinoline and deoxypyridinoline at 6, 9, and 12 months were significantly reduced in comparison with basal values and group C (P < .05). Pyridinoline and deoxypyridinoline levels were lower in group A than in group B throughout the study, but not significantly. In group A serum calcium levels were significantly increased after 6 months. At 12 months, no significant difference was detected in lumbar bone mineral density values among the 3 groups and in comparison with basal values. CONCLUSION: Both combined oral contraceptives exert a similar positive influence on bone turnover and bone-sparing effect in young postadolescent women. LEVEL OF EVIDENCE: II-1

Use of leuprolide acetate plus tibolone in the treatment of severe premenstrual syndrome

OBJECTIVE To evaluate the effectiveness of GnRH agonist (GnRH-a) plus tibolone in the treatment of severe premenstrual syndrome (PMS). DESIGN Prospective, double-blind, placebo-controlled clinical trial. SETTING Department of Obstetrics and Gynecology, University of Naples Federico II, Naples, Italy. PATIENT(S); Thirty patients affected by severe PMS, aged 23-29 years (mean age +/- SD, 25.3 +/- 2.9 years). INTERVENTION(S) Treatment for two cycles with leuprolide acetate depot (3.75 mg IM for 28 days) in association with tibolone (2.5 mg/d orally) or placebo (1 tablet per day orally). MAIN OUTCOME MEASURE(S) The mean severity of each symptom and sign of PMS was evaluated using a visual analog scale during the last 7 days of each treatment cycle in comparison with the last 7 days of the cycle before treatment. RESULT(S) Mean scores for each of the adverse psychological/physical and positive psychological symptoms were significantly improved during treatment. No statistically significant difference was detected between patients treated with tibolone and placebo. A significantly lower number of hot flushes per day was observed in groups treated with GnRH-a and tibolone in comparison with GnRH-a and placebo. CONCLUSION(S) Tibolone administered in association with GnRH-a does not reduce the therapeutic effect of GnRH-a in women affected by PMS. Tibolone used in association with GnRH-a may provide long-term medical treatment for women with PMS.

Efficacy of a polyethylene oxide-sodium carboxymethylcellulose gel in prevention of intrauterine adhesions after hysteroscopic surgery.

STUDY OBJECTIVES To assess the efficacy of a polyethylene oxide-sodium carboxymethylcellulose gel (Intercoat; Gynecare, division of Ethicon, Inc., Somerville, NJ) in preventing the development of de novo intrauterine adhesions (IUAs) after hysteroscopic surgery and to rate the patency of the internal uterine ostium at 1-month follow-up diagnostic hysteroscopy. DESIGN Randomized controlled study (Canadian Task Force classification I). SETTING University hospital. PATIENTS One hundred ten patients diagnosed during office hysteroscopy as having single or multiple lesions suitable for surgical treatment or resistant dysfunctional uterine bleeding requiring endometrial ablation. INTERVENTIONS Patients were randomized to 2 groups. Group 1 underwent hysteroscopic surgery plus intrauterine application of Intercoat gel, and group 2 underwent hysteroscopic surgery only (control group). Follow-up office hysteroscopy was performed at 1 month after surgery to assess the rate and severity of IUA formation and to rate the patency of the internal uterine ostium after the surgical intervention. MEASUREMENTS AND MAIN RESULTS Compared with the group 2, group 1 demonstrated a significant reduction in the incidence (6% vs 22%; p <.05) of de-novo IUAs. Application of the gel seemed to reduce the severity of IUAs, with fewer moderate and severe IUAs at follow-up in group 1 in comparison with group 2 (33% vs 92%). Furthermore, group 1 demonstrated significant improvement in the degree of patency of the internal uterine ostium (41.9% of cases) in comparison with diagnostic office hysteroscopy performed at enrollment (p <.05). In contrast, in group 2, worsening of patency of the internal uterine ostium was recorded in 18.2% of cases (p <.05). CONCLUSIONS Intercoat gel seems to prevent de novo formation of IUAs and to improve the patency of the internal uterine ostium at follow-up hysteroscopy. However, larger studies are needed to confirm these findings.

The Levels of the Endocannabinoid Receptor CB2 and Its Ligand 2-Arachidonoylglycerol Are Elevated in Endometrial Carcinoma

The endocannabinoid system plays protective roles against the growth and the spreading of several types of carcinomas. Because estrogens regulate this system both in physiological states and cancer, in this paper we evaluated its involvement in endometrial carcinoma, a well-known estrogen-dependent tumor. To test whether the endocannabinoid system is expressed in endometrial cancer, tissue samples were collected both from 18 patients undergoing surgical treatment for endometrial adenocarcinoma and 16 healthy age-matched controls, and treated for Western blot and immunohistochemical analysis. Moreover, tissues were dounce homogenized and submitted to endocannabinoid measurement by liquid chromatography-mass spectrometry. To evaluate the physiological role of the endocannabinoid system, a human endometrial cancer cell-line (AN3CA) was used and transiently transfected with a plasmid containing the cDNA for the endocannabinoid receptor CB(2). Cells were incubated for 48 h with an agonist (JWH133) (10 mum) or antagonist (SR144528) (1 mum) of CB(2) 24 h after transfection, and cell proliferation was measured by the 3-[4,5-dimethyltiazol-2yl]-2,5 diphenyltetrazolium bromide formazan assay. In human endometrial carcinoma biopsies the expression of CB(2) receptor and the levels of its ligand, 2-arachidonoylglycerol increased, whereas monoacylglycerol lipase, an enzyme responsible for 2-arachidonoylglycerol degradation, was down-regulated. Immunohistochemical analysis revealed that CB(2) was overexpressed only in malignant endometrial cells. CB(2)-overexpressing AN3CA cells showed a significant reduction in cell vitality compared with parental AN3CA cells: incubation with the selective CB(2) antagonist SR144128 restored the viability of CB(2)-overexpressing cells to that of untransfected cells. In conclusion, the endocannabinoid system seems to play an important role in human endometrial carcinoma, and modulation of CB(2) activity/expression may account for a tumor-suppressive effect.

Are Diabetes, Hypertension, and Obesity Independent Risk Factors for Endometrial Polyps?

STUDY OBJECTIVE To investigate whether diabetes, hypertension (HTN), and obesity can be considered risk factors for endometrial polyps (EPs) independently of age and menopausal status. DESIGN Retrospective analysis (Canadian Task Force classification III). SETTING Department of Obstetrics and Gynecology of the University of Foggia, Italy. PATIENTS A total of 353 Caucasian women undergoing office hysteroscopy to assess abnormal uterine bleeding, infertility, cervical polyps, and abnormal sonographic patterns. INTERVENTIONS Demographic characteristics and data on diabetes, HTN, and menopausal status were collected and anthropometric parameters were analyzed. Vaginoscopic hysteroscopy was performed with a 5-mm continuous-flow operative office hysteroscope. When present, EPs were treated during the same procedure by means of 5-Fr scissors or electrode. MEASUREMENTS AND MAIN RESULTS In 134 (38%) of 353 cases, EPs were found. Univariable and multivariable analysis were performed to verify the presence of a statistically significant association among age, menopause, HTN, obesity, diabetes (independent variables), and the presence of EPs. Univariable logistic analysis showed a statistically significant association among age, menopause, HTN, obesity, and the presence of EPs. However, when multivariable logistic regression was performed, all the independent variables, except age, lost statistical significance (OR 1.05, 95% CI 1.02-1.07, p <.001). CONCLUSION Although it appears that EP is a disorder of aging, the significance of diabetes, HTN, and obesity, as well as menopause, on the development of EPs should be reconsidered.