Contraception during Coronavirus-Covid 19 pandemia. Recommendations of the Board of the Italian Society of Contraception.

Purpose: The Italian Society of Contraception identified as one of its priorities the need to give recommendations on management of contraception during Coronavirus-Covid 19 pandemiaMaterials and methods: A concise communication was produced which summarises in an easy-to-read format suitable for clinicians the management of the different contraceptives mostly used. Information how to manage contraception in different conditions is presented.Results: Women may, in general, continue to use either intrauterine and or hormonal contraceptives. The use of condom should be added to any hormonal contraceptive, when the contraceptive efficacy is reduced or when women stop the contraceptive method.Conclusion: At the present time, during the Coronavirus-Covid 19 pandemia, no data contraindicate the use of intrauterine or hormonal contraceptives. Conversely the use of an appropriate contraception is advocate to prevent unintended pregnancies.

Monurelle Biogel® vaginal gel in the treatment of vaginal dryness in postmenopausal women.

OBJECTIVES: To evaluate efficacy, tolerability and safety of Monurelle Biogel® vaginal gel for treatment of vaginal dryness. METHODS: Multicenter, national, randomized, controlled vs. no-treatment, open-label study. Ninety-five postmenopausal women were randomized (48 to Monurelle Biogel® and 47 to no treatment). Primary endpoint was the change of Verbal Rating Scale (VRS) total score of vaginal atrophy (VA) symptoms after 8-week treatment. The main secondary endpoints were VRS single-item score, Vaginal Health Index (VHI) score, Maturation Index (MI), Female Sexual Function Index (FSFI), and Female Sexual Distress Scale-Revised (FSDS-R). RESULTS: The VRS total score was statistically significant in favor of the treatment group on day 28 (p = 0.001) but not on day 56 (p = 0.064). By excluding women who were not sexually active, the total VRS scores reached the criteria for clinical success in 27/43 subjects (62.8%) in the control arm and in 38/46 subjects (82.6%) in the treatment arm (p = 0.035) on day 56. The VHI score significantly changed in the active arm (4.71 ± 4.85 vs. 0.28 ± 1.71) (p < 0.001) on day 56. Even the MI significantly improved, with an increase in the percentage of superficial cells (p = 0.01). The improvements in both VHI and MI were still present at the follow-up visit after the discontinuation of the treatment (day 84). Sexual function and distress showed a statistical significant difference on day 56. CONCLUSIONS: Monurelle Biogel® vaginal gel applied twice daily for 8 weeks is effective in relieving vaginal dryness and other VA symptoms. Such a clinical meaningful effect persists at least 4 weeks and is supported by an improvement in the vaginal environment. Trial Registration clinicaltrials.gov Identifier: NCT02994342.

Hysteroscopic outpatient metroplasty to expand dysmorphic uteri (HOME-DU technique): a pilot study.

The new classification system of uterine anomalies from the European Society of Human Reproduction and Embryology and the European Society for Gynaecological Endoscopy defines T-shaped and tubular-shaped infantilis uteri as 'dysmorphic'. Such malformations have been proven to be associated with poor reproductive performance. A prospective observational study was conducted with 30 infertile women with dysmorphic uterus who underwent the novel Hysteroscopic Outpatient Metroplasty to Expand Dysmorphic Uteri (HOME-DU ) technique. Incisions are made on the uterine walls with a 5 Fr bipolar electrode. The procedure was conducted in outpatients under conscious sedation, using a 5-mm office hysteroscope. The technique was successful in all cases without complications. A net increase of uterine volume was found, as measured at hysteroscopy and three-dimensional transvaginal ultrasound (P < 0.001). Uterine morphology improved in all patients but one. At mean follow-up of 15 months, clinical pregnancy rate was 57% and term delivery rate 65%. These early data support HOME-DU as safe and effective in expanding the volume and normalizing the appearance of the uterine cavity of dysmorphic uteri. Although the cohort was small, pregnancy and live births outcomes were favourable in this poor-prognosis group, implying desirable benefits, which should be compared with other techniques.

A case of ovarian torsion in a patient carrier of a FSH receptor gene mutation previously affected by spontaneous ovarian hyperstimulation syndrome.

We here report a case of ovarian torsion in a patient with an history of two previous episodes of spontaneous ovarian hyperstimulation syndrome during her two pregnancies. A mutation of follicle-stimulating hormone receptor (FSHr) gene was identified in this patient and in other members of the family. Two years after her successful second pregnancy, the patient showed signs of severe thyroiditis during administration of oral contraceptive, with suppressed TSH and increased thyreoglobulin, in the absence of any abnormalities of the auto-antibodies. In few days, she developed severe pelvic pain and ultrasonographic evidence of increased ovarian volume. She underwent laparoscopy with unilateral adnexectomy for ovarian ischemic necrosis due to adnexal torsion. Our experience suggests that patients' carrier of a mutation of FSHr gene are at risk of ovarian pathologies also when non-pregnant and in the presence of low TSH levels. Further investigations are needed for an appropriate knowledge of typical and atypical manifestations of spontaneous ovarian hyperstimulation syndrome.

Synthetic cyanoacrylic glue in the prevention of post-operative lymphocele after pelvic lymphadenectomy in patients with uterine malignancies: A prospective, single-blind, preliminary study.

OBJECTIVES: Lymphoceles are among the most common post-operative complications of pelvic lymphadenectomy, with a reported incidence of 1% to 29% in gynecology oncology. Several studies evaluated the effectiveness of biological glues on reducing lymphoceles, but no data on gynecological patients are available. We evaluated the effectiveness of cyanoacrylic glues (n-butyl cyanoacrylate) (Glubran 2 - GEM s.r.l., Italy) in preventing lymphocele on 30 patients who underwent pelvic lymphadenectomy for endometrial or cervical cancer. METHODS: Single-blind prospective randomized study. Patients were divided into 2 groups: pelvic lymphadenectomy plus n-butyl cyanoacrylate (treatment group: 44 patients) and pelvic lymphadenectomy without n-butyl cyanoacrylate (control group: 44 patients). Primary endpoint was incidence of pelvic lymphocele in the two groups 30 days after surgery, and evaluated with pelvic ultrasound and RMI examination. Secondary endpoints evaluated drainage volume of lymphorrhea 36, 48, 72 and 96 h after surgery. RESULTS: 15% in the treatment group and 36.6% in the control group had lymphocele 1month after the procedure (p<0.03; RR 0.4 [95% CI 0.152-0.999]). Concerning the secondary outcome in group A the amount of lymphorrhea presented a constant significant decrease during evaluation; on the contrary, in group B, after an initial decrease at 48 h, the amount of lymphorrhea remained unchanged; at all considered times the amount of lymphorrhea resulted significantly greater in controls. CONCLUSION: Intraoperative application of n-butyl cyanoacrylate seems to reduce lymph production after pelvic lymphadenectomy, providing a useful additional treatment option for reducing drainage volume and preventing lymphocele development after pelvic lymphadenectomy.

Extreme reverse seasonal variations of indoor radon concentration and possible implications on some measurement protocols and remedial strategies.

Indoor radon levels in dwellings are typically higher in cold months than in warm ones. The indoor radon concentration might experience an inverse seasonal behaviour - i.e., radon levels much higher in summer than in winter - under specific circumstances. In the framework of a study on long-term variations of annual radon concentration carried out in some tens of dwellings in Rome and surrounding small towns, two dwellings with very high - up to extreme - reverse seasonal variations were accidently discovered. These dwellings were located in a volcanic area, and they are both south-oriented and located on the lower part of a hill. In one of them, radon concentration was monitored by a continuous radon monitor for two years to find out when the greatest rises in radon levels occur. The indoor radon concentration resulted to experience extremely rapid, i.e. very few hours, increases up to 20 000 Bq m-3 during the spring period (i.e., April, May, and June especially). After about ten years from the first observation, the indoor radon concentration of the same house was monitored again for about five years: radon concentration peaks previously observed were found to be unchanged in terms of absolute values, duration, rising time and occurrence period. These reverse seasonal variations may lead to significant underestimation of the actual annual average radon concentration in case of measurements lasting less than one year if performed during the cold season and especially when seasonal correction factors are used. Moreover, these results suggest adopting specific measurement protocol and remediation strategies in houses having some peculiar characteristics, mainly regarding orientation, position, and attachment to the ground.

Models of radon exhalation from building structures: General and case-specific solutions.

Assessing the radon activity that exhales from building structures is crucial to identify the best strategies to prevent radon from entering a building or reducing its concentration in the inhabited spaces. The direct measurement is extremely difficult, so the common approach has consisted in developing models describing the radon migration and exhalation phenomena for building porous materials. However, due to the mathematical complexity of comprehensively modelling the radon transport phenomenon in buildings, simplified equations have been mostly adopted until now to assess the radon exhalation. A systematic analysis of the models applicable to radon transport has been carried out and it has resulted in four models differing in the migration mechanisms - only diffusive or diffusive and advective - and the presence of inner radon generation. The general solutions have been obtained for all the models. Moreover, three case-specific sets of boundary conditions have been formulated to account for all the actual scenarios occurring in buildings: both perimetral and partition walls and building structures in direct contact with soil or embankments. The corresponding case-specific solutions obtained serve as a key practical tool to improve the accuracy in assessing the contribution of building materials to indoor radon concentration according to the site-specific installation conditions in addition to the material inner properties.

A New Combined Laparoscopic-Vaginal Lateral Suspension Procedure for the Treatment of Pelvic Organ Prolapse.

OBJECTIVE: To show an original technique of a new combined vaginal-laparoscopic lateral suspension in Hysteropexy with cistocele and rectocele. In recent years, changes in attitudes toward sexuality, psychological value of reproductive organs and the desire to preserve fertility have led to a growing interest in uterine-preserving surgery for Pelvic Organ prolapse. Minimally invasive procedures derived from sacrocolpopexy are considered the gold standard in the treatment of apical Pelvic Organ prolapse. However, dissection at the level of the promontory may be challenging, particularly in obese women and when an anatomical variation exists. This may be associated with rare but serious neurological or ureteral morbidity as well as life-threatening vascular injury. MATERIALS AND METHODS: Stepwise demonstration of the technique with narrated video footage. Local institutional review board was consulted, and this study was exempted from approval. RESULTS: Our technique entails 2 times. During the vaginal time, a polypropylene mesh is fixed to the cervical fascia and the 2 extremities are introduced in the abdominal cavity through the Douglas pouch. During the laparoscopic time, a retroperitoneal tunnel is made along the walls of the lateral abdominal walls; thereafter, each of the 2 extremities of the mesh is passed through the omolateral tunnel and "tension-free" suspended to the abdominal wall. CONCLUSION: Our combined technique may allow a safer approach, reducing the risks of serious complications. Moreover, it leads to a more physiological orientation of the vaginal axis. Further controlled studies are needed to confirm our suggestion.

Impact of temporal variability of radon concentration in workplaces on the actual radon exposure during working hours.

For workplaces where significant diurnal variations in radon concentrations are likely, measurements to evaluate average radon concentration during working hours could be useful for planning an optimized protection of workers according to the 2013/59/Euratom Directive. However, very few studies on this subject, generally limited to periods of few weeks, have been published. Therefore, a study has been conducted to evaluate the actual long-term radon exposure during working hours for a sample of 33 workplaces of four different types (postal offices, shops, restaurants, municipal offices), mainly located at the ground floor, and with expected considerable air exchange rate occurring during working hours due to frequent entrance/exit of persons or mechanical ventilation. The results show that the difference between the average radon level during working hours and that one during the whole day is about 20% on average and ranges from 0 to 50%. These observed differences, generally smaller compared with those found in other similar studies, are nearly the same if the analysis is restricted to workplaces with annual radon level higher than 300 Bq m-3, and therefore natural or mechanical ventilation normally present during working hours of the monitored workplaces cannot be considered an effective mitigation measure. However, the costs and time-response characteristics of the active monitors, as those used for the present study, will probably allow using more frequently a similar measurement strategy in workplaces.

Transdermal estradiol and oral or vaginal natural progesterone: bleeding patterns.

OBJECTIVE: To evaluate the effects on bleeding pattern of two different doses of natural progesterone (NP) administered per os or per vagina in association with transdermal estradiol in a continuous, sequential estrogen-progestin therapy. METHODS: A prospective, randomized trial was conducted on 100 patients randomized into four groups. Each group received transdermal 17beta-estradiol treatment at the dose of 50 microg/day. Groups A and B received NP per os at the dose of 100 mg/day and 200 mg/day, respectively. Groups C and D received NP per vagina at the dose of 100 mg/day and 200 mg/day, respectively. RESULTS: After 12 cycles of treatment, no significant differences were observed in endometrial thickness between groups, suggesting that all treatments are effective in balancing the effects of estradiol on endometrium. Regarding bleeding control, patients in Groups C and D showed a higher number of episodes of regular bleeding than patients in Groups A and B and fewer episodes of spotting. The better control of bleeding was associated with a higher treatment compliance in patients who received vaginal NP, with a larger percentage of women completing the study. CONCLUSION: Transdermal estrogen replacement therapy combined with 100 mg of micronized NP administered per vagina from the 14th day to the 25th day of each 28-day cycle leads to good cycle control and provides excellent patient satisfaction without serious side-effects. This therapy could be a treatment of first choice in early postmenopausal patients.

SHORT-TERM ANNUAL VARIATIONS OF RADON CONCENTRATION IN WORKPLACES: SOME RESULTS IN A RESEARCH INSTITUTE.

Many international and national regulations on radon in workplaces, including the 2013/59/Euratom Council Directive, are based on the annual average of indoor radon concentration, assuming it is representative of the long-term average. However, a single annual radon concentration measurement does not reflect annual variations (i.e. year-to-year variations) of radon concentration in the same location. These variations, if not negligible, should be considered for an optimized implementation of regulations. Unfortunately, studies on annual variations in workplaces can be difficult and time-consuming and no data have been published on scientific journals on this issue. Therefore, we carried out a study to obtain a first evaluation of short-term annual variations in workplaces of a research institute in Rome (Italy). The radon concentration was measured in 120 rooms (mainly offices and laboratories) located in 23 buildings. In each room, two 1-year long measurements were performed, with an interval between the two measurements of up to 3 years. The results show variability between the two 1-year long measurements higher than the variability observed in a sample of dwellings in the same area. Further studies are required to confirm the results and to extend the study to other types of workplaces.

REPRODUCIBILITY OF RADON-IN-WATER MEASUREMENTS BY EMANOMETRY TECHNIQUE.

The emanometry test method is one of the detection techniques of radon in water satisfying requirements of Directive 2013/51/Euratom with regards to the detection limit. Quality assurance (QA) procedures were developed and implemented for a measuring system relying on such a technique. These procedures mainly address the following: (i) the assembling of each component of the degassing circuit, (ii) the sample transfer from the transport container to the degassing vessel and (iii) the control of all the influencing quantities. Three identical measuring systems have been used to analyse in parallel 39 water samples with the aim to evaluate the effectiveness of QA procedures in terms of reproducibility. The results showed quite low variability (<15% for the 84% of measurements in the range 10-100 Bq L-1) among the three different measuring systems.

Relugolix for the treatment of uterine fibroids.

INTRODUCTION: Uterine fibroids (UF) are benign tumors common in premenopausal women, with strong impact on the health-care systems. For many years, surgery represented the only therapy for symptomatic fibroids. However, clinicians are observing a switch from surgery to noninvasive methods; in particular, medical treatment has been shown to be efficacious in obtaining a bleeding reduction and in ameliorating patient conditions. AREAS COVERED: The authors review the current options available for the treatment of women with UF, with a special focus on the newest one, relugolix. It is an orally active non-peptide Gonadotropin-releasing hormone (GnRH)-receptor antagonist recently licensed for women with symptomatic fibroids. Relugolix is a well-tolerated safe drug; it is effective in inducing a dose-dependent decrease in menstrual blood loss, with faster reduction of heavy menstrual bleeding (HMB) and a greater shrinkage in fibroid volume compared to the current standard of GnRH agonist treatment. EXPERT OPINION: Relugolix is a promising drug for the non-surgical treatment of women with UF. To date, the only published data come from a well-selected Japanese female population study while results from worldwide ongoing studies are ongoing in order to confirm the efficacy of this GnRH agonist receptor.

EVALUATION OF REPRESENTATIVENESS OF SAMPLES USED FOR INDOOR RADON SURVEYS.

The estimation of the indoor radon exposure of the population of a country is generally carried out by the means of surveys designed in order to have sample representativeness as a target (population-based survey). However, the estimates of radon concentration distributions could be affected by biases if sampling was not random or in case of differences between sample and target population characteristics. In this work, we performed a preliminary check of the representativeness of the sample used for the second Italian national survey aimed to evaluate radon concentration distribution in each Province. We found that sampled dwellings are mostly located in the main administrative centres, where average radon concentration is generally lower, as compared with the other towns of the Province. The potential source of bias identified in this work suggests to carefully control the occurrence of a sampling imbalance between 'main' cities and other cities of Province and to take it into account in data analysis.

SPATIAL VARIABILITY OF INDOOR RADON CONCENTRATION IN SCHOOLS: IMPLICATIONS ON RADON MEASUREMENT PROTOCOLS.

The requirements about radon measurements in schools and public buildings included in most of the national and international legislations are generally restricted to all the rooms located at the ground floor and basement, assuming the soil beneath the building as the main source of indoor radon. In order to verify such an assumption for small buildings having at maximum two floors, a preliminary study was performed in 50 schools located in 15 municipalities of the Republic of Srpska. Results of this study suggest that a protocol requiring measurements at the ground floor only may be considered adequate. Due to the high radon spatial variability for rooms at the ground floor, it is preferable to require measurements in a high number of rooms (preferably in all of them) in order to assess the compliance with the reference level established by the legislation.

Radon concentration in self-bottled mineral spring waters as a possible public health issue.

Since 2013, the Council Directive 2013/51/Euratom has been regulating the content of radioactive substances in water intended for human consumption. However, mineral waters are exempted from this regulation, including self-bottled springs waters, where higher radon concentration are expected. Therefore, a systematic survey has been conducted on all the 33 mineral spring waters of Lazio (a region of Central Italy) in order to assess if such waters, when self-bottled, may be of concern for public health. Waters have been sampled in two different ways to evaluate the impact of bottling on radon concentration. Water sampling was possible for 20 different spring waters, with 6 samples for each one. The results show that 2 (10%) of measured mineral spring waters returned radon concentrations higher than 100 Bq L-1, i.e., the parametric value established by the Council Directive. These results, if confirmed by other surveys involving a higher number of mineral spring waters, would suggest regulating also these waters, especially in countries like Italy for which: (i) mineral water consumption is significant; (ii) mineral concession owners generally allow the consumers to fill bottles and containers, intended for transport and subsequent consumption, directly from public fountains or from fountains within the plant; (iii) the consumers' habit of drinking self-bottled mineral water is widespread.

Hippocampal sparing in stereotactic radiotherapy for brain metastases: To contour or not contour the hippocampus?

PURPOSE: The aim of our study was to evaluate hippocampal irradiation in patients treated with fractionated stereotactic brain radiotherapy. PATIENTS AND METHODS: Retrospective hippocampal dosimetric analysis performed on 22 patients with one to four brain metastases treated with fractionated stereotactic radiotherapy using volumetric intensity-modulated arc therapy. Original plans did not include hippocampus as avoidance structure in optimization criteria; hippocampus was retrospectively delineated on magnetic resonance coregistered with planning CT and using as reference the RTOG 0933 atlas. Hippocampus was defined both as a single and as pair organ. Constraints analysed were: Dmax<16Gy, D40%<7.3Gy, D100%=Dmin<9Gy. Assuming a α/ß ratio of 2Gy, biologically equivalent dose in 2Gy fractions was calculated. Hippocampal-sparing plans were developed in cases where hippocampal constraints were not respected in the original plan. RESULTS: Among constraints analysed Dmax and D40% have been exceeded in ten out of 22 cases. The constraints were not respected in patients with more than one metastatic lesion and in three patients with only one lesion. Considering all exceeded constraints values in non-hippocampal sparing plans, the 50% of them was respected after replanning. No significant differences were found among conformity and homogeneity index between non-hippocampal sparing and hippocampal sparing plans. CONCLUSION: Volumetric intensity-modulated arc therapy hippocampal sparing plans significantly decreases dose to hippocampus assuring an equal target coverage and organs at risk avoiding.

Endometrioma size is a relevant factor in selection of the most appropriate surgical technique: a prospective randomized preliminary study.

OBJECTIVES: To assess and compare the ovarian reserve in patients with different-sized endometriomas undergoing cystectomy or ablative surgery in order to determine the best surgical approach to safeguard healthy ovarian tissue. STUDY DESIGN: Prospective randomized study on 48 patients with unilateral single ovarian endometriomas. Patients were allocated into two groups based on endometrioma size: <5cm (n=26, Group A, small endometriomas) and ≥5cm (n=22, Group B, large endometriomas). Each group was randomized to coagulation or excision treatment (1:1 ratio) before the procedure. Anti-Müllerian hormone (AMH) levels were evaluated before surgery and 3 months after surgery. RESULTS: Both ablation and excision resulted in a significant reduction in AMH level regardless of endometrioma size. A significant interaction effect was observed between endometrioma size and type of surgical technique (analysis of covariance p for interaction=0.039): in Group A, no significant difference was found between the two surgical techniques (-17.6±4.7% vs -18.2±10.6%), whereas in Group B, the excision group showed a significantly greater percentage decrease in AMH level compared with the ablation group (-24.1±9.3% vs -14.8±6.7%, p=0.011). CONCLUSIONS: Both ablative and excision treatment of endometriomas have a negative effect on ovarian function. Endometrioma size is associated with the magnitude of ovarian reserve damage following excision treatment, but in the case of ablative treatment, the decrease in AMH serum level is independent of the size of the cyst. In surgical treatment of large endometriomas, the decrease in AMH level is more consistent and much more severe following cystectomy than ablation.

Changes in bone mineral density and calcium metabolism in breastfeeding women: a one year follow-up study.

The aim of this study was to evaluate bone metabolism in breast-feeding women. Thirty-six healthy women (24-31 yr, mean age 28.1 +/- 1.8 yr) were divided into 2 groups: group A including 18 women that exclusively breast-fed for 6 months, and group B composed of 18 women in whom lactation was inhibited with bromocriptine. Three days and 3, 6, and 12 months after delivery, distal radius, and lumbar spine bone mineral density (BMD) and some of the main biochemical parameters of bone turnover were assessed. In group A, we detected a significant decrease (P < 0.01 vs. basal and group B) in lumbar spine and distal radium BMD during breast-feeding. An incomplete recovery of BMD was detected 6 months after breast-feeding interruption. In group B, no significant changes occurred in BMD. In group A, during lactation, serum osteocalcin and urinary hydroxyproline showed a significant increase (P < 0.01 vs. basal and group B), while parathyroid hormone was significantly decreased (P < 0.02 vs. basal and group B). No significant variations in these parameters occurred in group B throughout the study. Our findings show that a significant decrease of BMD occurs during lactation and that this decrease is only partially recovered 6 months after interrupting breast-feeding.