Stem Cells and Infertility: A Review of Clinical Applications and Legal Frameworks.

Infertility is a condition defined by the failure to establish a clinical pregnancy after 12 months of regular, unprotected sexual intercourse or due to an impairment of a person's capacity to reproduce either as an individual or with their partner. The authors have set out to succinctly investigate, explore, and assess infertility treatments, harnessing the potential of stem cells to effectively and safely treat infertility; in addition, this paper will present the legal and regulatory complexities at the heart of stem cell research, with an overview of the legislative state of affairs in six major European countries. For couples who cannot benefit from assisted reproductive technologies (ART) to treat their infertility, stem-cells-based approaches have been shown to be a highly promising approach. Nonetheless, lingering ethical and immunological uncertainties require more conclusive findings and data before such treatment avenues can become mainstream and be applied on a large scale. The isolation of human embryonic stem cells (ESCs) is ethically controversial, since their collection involves the destruction of human embryonic tissue. Overall, stem cell research has resulted in important new breakthroughs in the treatment of infertility. The effort to untangle the complex web of ethical and legal issues associated with such therapeutic approaches will have to rely on evidence-based, broadly shared standards, guidelines, and best practices to make sure that the procreative rights of patients can be effectively reconciled with the core values at the heart of medical ethics.

Obstetric and Gynecological Admissions and Hospitalizations in an Italian Tertiary-Care Hospital during COVID-19 Pandemic: A Retrospective Analysis According to Restrictive Measures.

BACKGROUND: The national lockdown and the different restrictions applied in 2020 during the COVID-19 pandemic brought several changes to hospitalization procedures. The aim of this study was to evaluate the patterns in access to emergency services and hospitalization in a tertiary-care obstetric and gynecological emergency department (OG-ED) throughout the restrictions applied during 2020. METHODS: A single-center retrospective comparative study on data from January to December 2020 was carried out on the following timeframes: January to February 2020 (before COVID-19 pandemic), March to June 2020 (nationwide lockdown period), July to September 2020 (removal of restrictive measures), October to December 2020 (regional lockdown) and compared to the same periods of 2019. All obstetric and gynecological patients with complete medical data admitted to the OG-ED were included. RESULTS: Overall, 4233 accesses for 2019 and 3652 for 2020 were reported, with a decreasing trend of -13.7%. Between March and June 2020 (nationwide lockdown) and 2019, the overall number of patients attending the OG-ED decreased compared to July-September and October-December differences (Δ -23.5% vs. -3.1% and -5.9%; p = 0.001 respectively) for 2020-2019, but this reduction was not statistically significant when compared to January-February (Δ -23.5% vs. -18.5%; p = 0.356). No significant differences for obstetric patients (Δ -1.8% vs. -1.0% vs. -2.3% and +1.9% respectively; p = 0.883) were noted. Hospitalizations showed a stable trend with an increase between October-December 2019 and 2020 (Δ +4.6%; p = 0.001 vs. January-February (+2.4%) and March-June (+2.6%) 2019-2020), mainly related to regional lockdowns. CONCLUSIONS: In contrast to available national studies, in our institution, the overall rate of OG-ED admissions was slightly reduced with a similar trend of decrease even before COVID-19, with an increase in admissions for serious issues, despite expectations that the suspension of elective admissions and outpatient services would have led to an increase in non-urgent hospitalizations during the COVID-19 lockdown period.

Symptomatic COVID-19 in Pregnancy: Hospital Cohort Data between May 2020 and April 2021, Risk Factors and Medicolegal Implications.

Pregnancy does not appear to increase susceptibility to SARS-CoV-2 infection, but some physiological changes, such as the reduction of residual functional volumes, elevation of the diaphragm, and impaired cellular immunity, may increase the risk of severe disease and result in a higher risk of complications. The article's primary objective is to evaluate the factors associated with symptomatic COVID-19 disease in pregnancy. The secondary objective is to describe maternal and neonatal outcomes and cases of vertical transmission of the infection. All pregnant women hospitalized with SARS-CoV2 infection were included in a prospective study in the UOC of Obstetrics and Gynecology, AOOR Villa Sofia-Cervello, Palermo, between May 2020 and April 2021. The patients who requested the termination of the pregnancy according to Law 194/78 were excluded. We included 165 pregnancies with a total number of 134 deliveries. Overall, 88.5% of the patients were asymptomatic at the time of admission and 11.5% were symptomatic. Of them, 1.8% of the patients required hospital admission in the intensive care unit. Symptoms occurrences were positively associated with the increase in maternal BMI (OR 1.17; p = 0.002), the prematurity (OR 4.71; p = 0.022), and at a lower birth weight (OR 0.99; p = 0.007). One infant tested positive for SARS-CoV2 nasopharyngeal swab; 11.4% of newborns had IgG anti SARS-CoV2 at birth; IgM was positive in 2.4% of newborns. There was no difference statistically significant difference in the vertical transmission of the infection among the group of symptomatic pregnant women and that of asymptomatic pregnant women.

The reproductive potential of uterus transplantation: future prospects.

BACKGROUND AND AIM: Absolute uterine factor infertility (AUFI) is a form of infertility whereby conception and/or maintenance of pregnancy is impossible as a result of uterine absence or its completed dysfunction. It affects 1/500 women of reproductive age while the incidence is about 8% of infertile couples. Uterus transplantation (UTx) has been gaining ground as a viable option to enable women with AUFI to have biological children and as an alternative to surrogacy, a highly controversial practice still banned in many countries. METHODS: The authors have set out to strike a reasonable balance between UTx benefits and the still numerous risks, whether clinical or ethical, associated with such an innovative form of transplant, which is not life-saving, requires immunosuppression throughout pregnancy and the organ to be removed right after childbirth. RESULTS: While still far from achieving mainstream status, considerable strides have been made in UTx outcomes, with many live births already recorded. Procedures from living donor are reportedly more effective in terms of success rates. Organ tissue engineering has been explored and developed with promising results. CONCLUSIONS: UTx entails various risks and ethical quandaries which have to do with reproductive autonomy and rights. New human attempts and clinical trials of UTx should be performed to further optimize the procedure in relation to safety and effectiveness. Techniques such as tissue engineering could lead in the medium-long term to a wholly bioengineered uterus to be used for transplantation, relying on scaffolds from decellularized organs or tissues that can be recellularized by several types of autologous somatic/stem cells. Such advances hold promise in terms of solving UTx-related complications and organ supply difficulties.

Systematic review of quality of life measures in patients with endometriosis.

OBJECTIVES: Endometriosis and quality of life has been the subject of much research, however, there is little consensus on how best to evaluate quality of life in endometriosis, resulting in many and diverse scales being used. In our study, we aim to identify quality of life scales used in endometriosis, to review their strengths and weaknesses and to establish what would define an ideal scale in the evaluation of endometriosis-related quality of life. MATERIALS AND METHODS: A search of the MEDLINE and EMBASE databases was carried out for publications in English and French for the period from 1980 to February 2017, using the words 'endometriosis' and 'quality of life'. Publications were selected if they reported on quality of life in patients with endometriosis and specified use of a quality of life scale. A quantitative and a qualitative analysis of each scale was performed in order to establish the strengths and weaknesses for each scale (systematic registration number: PROSPERO 2014: CRD42014014210). RESULTS: A total of 1538 articles publications were initially identified. After exclusion of duplicates and application of inclusion criteria, 201 studies were selected for analysis. The SF-36, a generic HRQoL measure, was found to be the most frequently used scale, followed by the EHP-30, a measure specific to endometriosis. Both perform well, when compared with other scales, with scale weaknesses offset by strengths. EHP-5 and EQ-5D also showed to be of good quality. All four were the only scales to report on MCID studied in endometriosis patients. CONCLUSION: For clinical practice, routine evaluation of HRQOL in women with endometriosis is essential both for health-care providers and patients. Both SF-36 and EHP-30 perform better overall with regard to their strengths and weaknesses when compared to other scales.

Laparoscopic-assisted Retropubic Midurethral Sling Placement: A Technique to Avoid Major Complications.

STUDY OBJECTIVE: To describe a technique for the safe placement of retropubic midurethral slings in patients undergoing concomitant laparoscopic surgery in order to avoid major complications associated with this procedure such as bladder perforation and retropubic hematomas. DESIGN: Step-by-step video demonstration of the technique. SETTING: A university tertiary care hospital. PATIENTS: Patients with an indication for retropubic midurethral sling placement because of recurrent stress urinary incontinence, intrinsic sphincter deficiency, or severe pelvic organ prolapse in whom a concomitant laparoscopic surgery has to be performed for other medical conditions. INTERVENTION: Laparoscopic opening and dissection of the Retzius space and insertion of the sling under a laparoscopic view of this space. MEASUREMENTS AND MAIN RESULTS: This technique has been mainly used in patients undergoing laparoscopic pelvic organ prolapse repair. No complications have been identified so far, even in high-risk patients such as those with previous Burch colposuspension. CONCLUSION: This is a simple and reproducible technique for preventing major complications associated with retropubic sling placement in patients undergoing laparoscopic surgery for other reasons. It also permits the immediate detection and even resolution of complications in case any arise. Even high-risk patients may be safely approached.

Laparoscopy-like operative vaginoscopy: a new approach to manage mesh erosions.

STUDY OBJECTIVE: Mesh erosion through the vagina is the most common complication of synthetic mesh used for pelvic organ prolapse repair. However, conventional transvaginal mesh excision has many technical limitations. We aimed at creating and describing a new surgical technique for transvaginal removal of exposed mesh that would enable better exposition and access, thus facilitating optimal treatment. DESIGN: A step-by-step video showing the technique. SETTING: A university tertiary care hospital. PATIENTS: Five patients previously submitted to pelvic organ prolapse repair using synthetic mesh, presenting mesh erosion through the vagina. INTERVENTIONS: Mesh excision using a laparoscopy-like operative vaginoscopy in which standard laparoscopic instruments are used through a single-incision laparoscopic surgery port device placed in the vagina. MEASUREMENTS AND MAIN RESULTS: In all cases, a very good exposure of the mesh was achieved, a minimal tissue traction was required, and the procedures were performed in a very ergonomic way. All the patients were discharged on the same day of the surgery and had a painless postoperative course. So far, there have been no cases of relapse. CONCLUSION: This seems to be a simple, cheap, and valuable minimally invasive technique with many advantages in comparison with the conventional approach. More cases and time are necessary to access its long-term efficacy. It may possibly be used for the management of other conditions.

Adenomyotic cyst in a 25-year-old woman: case report.

Adenomyotic cysts are uncommon findings, usually in the context of diffuse adenomyosis and <5 mm in diameter. Herein we report a 4.5-cm adenomyotic cyst in a 25-year-old nulliparous woman with severe dysmenorrhea and pelvic pain. Transvaginal ultrasonography and magnetic resonance imaging revealed a well-circumscribed hypoechogenic mass in the posterior uterine wall, well separated from the uterine cavity. Pathologic analysis demonstrated that the cyst was lined with endometrial epithelium and stroma and was surrounded by smooth muscle hyperplasia. In the literature, we found 30 reports of cysts with similar characteristics. Because this cyst has not been clearly defined, it has been called by various names including adenomyotic cyst, cystic adenomyosis, and cystic adenomyoma. We believe this lesion should not be called an adenomyoma, but is more correctly called an adenomyotic cyst or, depending on age at onset, a juvenile adenomyotic cyst.

[Prevention of topic toxicity of BCG with single-dose prulifloxacin. Preliminary results of a randomized pilot study]. / Prevenzione della tossicità topica del BCG con prulifloxacina in monodose. Risultati preliminari di uno studio pilota randomizzato.

INTRODUCTION: Toxicity is a major problem for patients undergoing intravesical therapy with Bacillus Calmette-Guérin (BCG) for the conservative management of intermediate or high-risk non-muscle invasive bladder cancer (NMI-BC). A prospective pilot trial was designed to evaluate the adoption of a single dose of prulifloxacin to prevent the toxicity of BCG. Treatment tolerability and its possible influence on BCG efficacy have been analyzed. MATERIALS AND METHODS: The study was designed to evaluate the action of prulifloxacin in patients with intermediate or high-risk NMI-BC, undergoing 6-week induction cycle of BCG. Main exclusion criteria were previous intravesical therapy, urinary infection and any other factor that could influence tolerability to BCG intravesical immunotherapy. The patients were randomized to receive BCG alone versus BCG plus prulifloxacin. BCG toxicity and local tolerability were evaluated by self-administered EORTC QLQ-BLS24 questionnaire, and BCG adverse events (AEs) were classified according a four-class classification. The toxicity and tolerability evaluations were performed at baseline, one week after every instillation and one week and one month after the last instillation. Cystoscopy and cytology were performed 3-monthly. Recurrence and progression were recorded. RESULTS: The study included 43 patients receiving 258 instillations of BCG. The patients were randomized to receive BCG alone (Arm A: 132 instillations in 22 patients) versus BCG plus prulifloxacin given as a single oral dose (600 mg) 6 hours after the instillation. An advantage in favor of prulifloxacin prophylaxis emerged, according to EORTC QLQ-BLS24, in overall incidence of nocturnal micturitions (56% vs 28.6%; p=0.001), insomnia (40% vs 14.3%; p=0.002), urgency (70% vs 42.6%; p=0.05), incontinence (44% vs 12.7%; p=0.01) and bothersome events due to intravesical therapy (84% vs 63.5%; p=0.02). Systemic class IIB and III adverse events occurred in only 14.2% and 3.5% of the patients, respectively. No class IV AE was detected. Due to the low incidence no statistically significant difference was evident between the two arms (p=0.6). Three patients of Arm B and 1 patient of Arm A interrupted the treatment, after the 3rd - 4th instillation. Anti-tuberculosis therapy war required for 3 months in only one patient. Three and 2 instillations were postponed for one-(two) week(s) in Arm B and Arm A, respectively. Prulifloxacin, generally well tolerated, was withdrawn in one patient due to skin allergic reaction. Recurrence rate at a mean follow-up of 12 months did not significantly differ between the two arms. CONCLUSIONS: Prulifloxacin decreases the incidence of local symptoms and improves the compliance to BCG intravesical therapy. Due to the low number of events, no evidence emerges in our study about its capability of preventing severe systemic toxicity, although it has proved effective in reducing local symptoms.