Clinical Research Directory

The Learning Curve of a Gynecology and Obstetrics Resident Performing Vaginal Natural Orifice Transluminal Endoscopic Surgery (V-NOTES) Hysterectomy in a University Hospital

This prospective observational study aims to evaluate the learning curve of obstetrics and gynecology residents performing Vaginal Natural Orifice Transluminal Endoscopic Surgery (V-NOTES) hysterectomy in a university hospital setting. V-NOTES hysterectomy is a minimally invasive surgical technique performed through the vaginal route that combines the advantages of laparoscopy without requiring abdominal incisions. The study will assess the progression of surgical performance of a resident performing V-NOTES hysterectomy under the supervision of an experienced attending surgeon. Key operative and postoperative outcomes will be recorded to evaluate the acquisition of surgical proficiency over time.

Multicenter Observational Cohort Study on the Epidemiology of Therapeutic Strategies in Patients Affected by Adenomyosis

The primary objective of this multicenter observational cohort study is to evaluate the current medical approach to the management of adenomyosis in women, with particular focus on treatment selection and treatment persistence. The secondary objective is to identify the criteria guiding therapeutic choices in daily clinical practice within a multicenter setting. Adenomyosis is a benign gynecological condition characterized by the presence of endometrial-like epithelial and stromal tissue within the myometrium. It mainly affects women aged 41 to 45 years and typically presents with symptoms such as chronic pelvic pain, dysmenorrhea, and menorrhagia. The most commonly used treatments include GnRH agonists, progestins, and intrauterine devices (IUDs); however, there are no universally accepted guidelines for the management of this condition, and therapeutic options remain a matter of debate. This is a multicenter observational cohort study with both prospective and retrospective recruitment of women affected by adenomyosis. Italian clinical centers will be included and will recruit patients aged between 20 and 50 years, with a diagnosis of adenomyosis confirmed by ultrasound or magnetic resonance imaging (MRI) and/or histology, and presenting significant symptoms (VAS ≥ 4 for pelvic pain or bleeding \> 100 on the Pictorial Blood Assessment Chart - PBAC). Cases of concomitant endometriosis, pregnancy, and conditions preventing informed consent will be excluded. Each center will collect data regarding the prescribed treatment, its effectiveness, and treatment persistence over time. The study duration will be 12 months, with data collection at baseline (V0), 3 months (V1), 6 months (V2), and 12 months (V3). Approximately 200 patients will be enrolled across 20 centers, with an enrollment period of 12 months. The analysis will be conducted based on the frequency of treatment use and changes in treatment response in relation to age, symptoms, and other clinical factors. Data Collection Methodology Patients will undergo regular clinical evaluations at 3 months, 6 months, and 12 months. Data will be collected using validated questionnaires (VAS, PBAC, SF-12). Transvaginal ultrasound examinations will be performed, and ferritin and hemoglobin levels will be measured. Treatment adherence and tolerability will be monitored through interviews and the recording of adverse events (AEs), including serious adverse events (SAEs). Data Analysis The analysis will be descriptive, focusing on the frequency of prescribed treatments and patient characteristics (age, symptoms, comorbidities). Continuous variables will be analyzed using mean and standard deviation (for normally distributed data) or median and range (for non-normally distributed data), while categorical variables will be analyzed using proportions and 95% confidence intervals. Differences between groups will be explored using appropriate statistical tests. Expected Results and Implications This study will provide crucial information on the epidemiology of therapeutic approaches to adenomyosis in Italy, helping to bridge existing knowledge gaps and supporting the development of evidence-based recommendations for clinical management. The results will help guide medical practice, improve patients' quality of life, and contribute to the development of therapeutic guidelines. Dissemination of Results The study results will be published in scientific articles in international peer-reviewed journals, with active participation of the physicians involved in the research.

Hugo™ Robotic-Assisted Surgery (RAS) System in Gynecological Subjects (Embrace Gynecology)

The purpose of this research is to evaluate the safety and performance of the investigational Medtronic Hugo™ Robotic Assisted Surgery (RAS) system when used during hysterectomy procedures, including patients being treated for cancer.

Association of Ultrasound Features of the Myometrium Suggestive of Adenomyosis and Clinical Symptoms

The goal of this study/research is to assess the relationship between ultrasound features of the myometrium suggestive of adenomyosis and clinical symptoms of adenomyosis and to establish a reporting system for adenomyosis assessing disease severity. Consecutive pre- and perimenopausal symptomatic and asymptomicasymptomatic women with an uterus presenting for gynaecological ultrasound exams will be asked to participate in the study. Routine gynecologicalgynaecological ultrasound exams will be performed and study participants will fill out a questionnaire on their symptoms (if any) and bleeding pattern. There will be one visit and no interventions.

RCT - Efficacy of Intravenous Vitamin C Versus Placebo on Estimated Blood Loss in Total Abdominal Hysterectomy

Intervention Group: Received two 1 gm doses of Vitamin C intravenously (IV). first Dose: At midnight on the day of surgery. Second Dose: Immediately after the surgical incision. Control Group: Received two doses of a normal saline intravenously (IV) at the exact same times. The primary outcome was to compare intraoperative blood loss between patients who received intravenous Vitamin C and those who did not, following an abdominal hysterectomy under general anesthesia. Intraoperative estimated blood loss (EBL) was meticulously quantified by weighing surgical gauze and measuring suction canister volumes. The secondary outcomes were to evaluate the potential benefits of Vitamin C administration, including: * Reduction in the decline of hematocrit levels after surgery. * Reduction of the length of hospital stay

Nintedanib for Improving Reproductive Outcomes in Adenomyosis

This study aims to evaluate the effectiveness and safety of nintedanib, an antifibrotic drug, in improving live birth rates for infertile women with adenomyosis who have frozen embryos. Based on promising animal data showing reduced uterine fibrosis, participants will be randomized to receive either standard progesterone therapy plus nintedanib or progesterone therapy alone for three months before undergoing a frozen embryo transfer cycle.

GnRH Agonist Pretreatment Duration and Letrozole Supplementation in Frozen Embryo Transfer for Adenomyosis Patients

This randomized clinical trial aims to assess the comparative effectiveness of different pre-treatment protocols prior to frozen embryo transfer (FET) among women with adenomyosis, providing evidence-based guidance for clinical decision-making. The main questions it aims to answer are: Does the protocol involving two doses of gonadotropin-releasing hormone agonist (GnRH-a) pretreatment result in a higher live birth rate compared to one dose of GnRH-a pretreatment in women with adenomyosis undergoing frozen embryo transfer? Does the protocol involving GnRH-a with letrozole supplementation result in a higher live birth rate compared to GnRH-a monotherapy in women with adenomyosis undergoing frozen embryo transfer? Eligible participants will undergo screening before endometrial preparation for FET, following which they will be randomly assigned to one of four groups: GnRH-a-1M, GnRH-a-2M, GnRH-a+LE-1M or GnRH-a+LE-2M. In the GnRH-a-1M group, participants will be pre-treated with one dose GnRH agonist before endometrial preparation. In the GnRH-a-2M group, participants will be pre-treated with two doses GnRH agonist before endometrial preparation. In the GnRH-a+LE-1M group, participants will be pre-treated with one dose GnRH agonist and letrozole 28 days before endometrial preparation. In the GnRH-a+LE-2M group, participants will be pre-treated with two doses GnRH agonist, along with daily 2.5 mg letrozole for 28 days since the first injection of GnRH agonist before endometrial preparation. After pre-treament, all participants will return for endometrial preparation in artificial cycles.

Does The Addition Of Letrozole To Ultra-Long GnRH Agonists Help Adenomyosis Patients in ART? The AURA Trial

The AURA Trial seeks to improve fertility treatment for women affected by a condition known as adenomyosis. Adenomyosis often leads to heavy menstrual bleeding, pelvic pain, dyspareunia and can make it more difficult to achieve and maintain a healthy pregnancy. In this randomized controlled trial participating women ≥ 18 years of age with a confirmed imaging diagnosis of adenomyosis according to Morphological Uterus Sonographic Assessment (MUSA) consensus will first undergo a thorough assessment. This initial workup includes reviewing medical history, assessing the characteristics of the uterus (volume, myometrial architecture, shape of the uterine cavity, stiffness, etc.) via 2D/3D transvaginal ultrasound, and obtaining blood tests to establish baseline hormone levels. Once enrolled, each participant will be assigned at random-without prior knowledge by either the woman or her care team-to one of two 90-day pre-treatment regimens. The first group will receive monthly injections of a GnRH agonist, a medication that temporarily suppresses ovarian function and lowers estrogen levels. The second group will follow the same injection schedule but will also take daily letrozole tablets, an aromatase inhibitor that further reduces estrogen production. The hope is that this combined approach will calm the inflammatory environment caused by adenomyosis, promote a more receptive uterus, and ultimately increase the likelihood of an embryo developing beyond the critical 12-week mark. At the end of the 90-day protocol, and after repeating all evaluations carried out during the enrolment phase, all women will proceed with the planned assisted reproductive technology cycle with the usual careful monitoring until the day of emrbyo transfer. To ensure correct interpretation of the results and to minimise the potential effect of any incompetent oocytes, only euploid embryos evaluated by pre-implantation genetic test or embryos derived from donated oocytes will be transferred. Pregnancy will be assessed first with a blood test, followed by an ultrasound scan at approximately six or seven weeks to confirm a clinical pregnancy. An ongoing pregnancy, defined by the detection of the fetal heartbeat beyond the 12th week, is the main measure of success. By participating in AURA, women and their families not only gain access to cutting-edge clinical care but also contribute valuable knowledge that could shape future standard treatments for adenomyosis-related infertility. For further information or to explore participation, please reach out to the Instituto Bernebu Assisted Reproduction Center, where our team is ready to guide you through every step of this important study.

Artificial Intelligence-Based Machine Learning to Diagnose and Classify Adenomyosis from Ultrasound Scans: a Multicentre Model Development Study

The aim of this study is to use the vast dataset of annotated ultrasound images of normal uterus and of adenomyosis of varying severity to train a neural network using deep learning framework (Pytorch) and automated machine learning tool (Vertex AI). The main question it aims to answer are: 1. Diagnostic performance of automated (Google Vertex AI (Artificial intelligence) vision) and deep learning (Pytorch) machine learning model 2. Time saved in assessment of adenomyosis per healthcare professional

Evaluation of the Efficacy and Safety of Microwave Ablation of Uterine Adenomyosis Under Improved Ultrasound Guidance

This study aims to compare the safety and efficacy of segmental power adjustment combined with uterine cavity hydro-isolation in microwave ablation of adenomyosis