Leiomyoma (Fibroid)

This research aims to establish a cohort to study the comprehensive management of ovarian cancer, including fallopian tube cancer and primary peritoneal cancer. It focuses on evaluating the effects of surgery, chemotherapy, and maintenance therapies on patient prognosis and quality of life. The study also investigates postoperative recovery, complications, adverse reactions, and analyzes factors influencing outcomes in these cancers. Participants will not receive any intervention as this is an observational study. Researchers will monitor patients undergoing standard treatments including surgery, chemotherapy, and targeted maintenance therapies such as PARPi. The study explores the safety and effectiveness of these treatments in real-world clinical settings without altering patient care. During the study, participants will be followed up to assess survival outcomes such as progression-free survival and overall survival about six months after study completion. Researchers will also track adverse reactions and monitor recovery and complications after treatments. The total participation period varies, with follow-ups focusing on long-term prognosis and safety.

Researchers are evaluating changes in bone mineral density in premenopausal women with heavy menstrual bleeding caused by uterine fibroids or moderate-to-severe pain from endometriosis. This Phase 3B, open-label study looks at the effects of continuous treatment with a relugolix combination tablet for up to 48 months (4 years), followed by a 1-year period to monitor bone health after stopping treatment. Participants will take a daily oral relugolix combination tablet containing relugolix 40 mg, estradiol 1 mg, and norethindrone acetate 0.5 mg for 4 years. Bone mineral density will be measured every 6 months using dual-energy X-ray absorptiometry (DXA). Some women who have completed a previous related study may join to complete 3 years of treatment. After treatment ends, bone density will be checked again at 6 months and 12 months during the follow-up year. Women in the study will have regular visits for bone density scans and health assessments, including physical and gynecological exams, lab tests, and vital signs. Researchers will track changes in bone density at the spine, hip, and femoral neck throughout treatment and follow-up. They will also monitor for any fractures or adverse events during the 4 years of treatment and the 1-year post-treatment period. Total participation can last up to 5 years including the follow-up.

This research aims to collect real-world data on the Cerene Cryotherapy Device, which is used to treat heavy menstrual bleeding in premenopausal women who have completed childbearing. The goal is to compare outcomes from everyday use with those reported in earlier clinical studies, better understanding its effectiveness, safety, and usage in routine care. The study is observational and involves women receiving treatment as part of their usual care. Women enrolled in this registry will have undergone Cerene treatment according to standard care practices. The study will include up to 300 women, with no additional interventions beyond their normal medical treatment. Data will be gathered through patient and physician surveys covering demographics, quality of life, procedure details, and clinical outcomes from before treatment through 12 months after. Participants will be involved for about 13 months from enrollment to one year post-treatment. Surveys will be completed at baseline and at specified times during follow-up. Researchers will assess outcomes such as the need for further interventions, treatment location, and quality of life changes. Physician feedback and cost analysis will also be collected to provide a comprehensive understanding of the device's use in real-world settings.

Researchers are evaluating whether acupuncture, specifically the Dragon's protocol, can help reduce chronic pelvic pain in women aged 21 to 65. This study focuses on non-endometriosis pelvic pain and includes women both with and without a history of sexual assault. The Dragon's protocol acupuncture aims to address both physical pain and emotional trauma by combining external and internal acupuncture treatments to reprocess traumatic memories and potentially calm the nervous system. Participants will first undergo 4 weeks of standard pain care such as physical therapy, psychotherapy, or usual medical management. Then, the same women will receive acupuncture treatments once weekly for 4 weeks using the Dragon's protocol. The acupuncture involves placing needles on both the back (external dragons) and front (internal dragons) of the body during each session, aiming to balance traumatic memories and pain responses. Throughout the study, participants will complete pain assessments using the Defense and Veterans Pain Rating Scale (DVPRS) and the Female Genitourinary Pain Index (GUPI) at multiple visits from week 0 to week 11. Women with a history of sexual trauma will also complete the PTSD Checklist for DSM-5 (PCL-5) to evaluate changes in PTSD symptoms. Visits include screening, baseline, weekly acupuncture sessions, and follow-ups, some of which may be virtual. Researchers will monitor pain levels and quality of life to understand the impact of the acupuncture treatment.

Researchers are evaluating the effects of two investigational herbal supplements, Elix Cycle Balance and Elix Daily Harmony, on symptoms related to uterine fibroids and the quality of life in women aged 20 to 45. This 24-week, single-arm, open-label virtual study involves 42 participants who have reported moderate to severe menstrual discomfort linked to fibroids. The study aims to understand how these supplements affect symptom severity and health-related quality of life over time. Participants will self-administer Elix Cycle Balance and Elix Daily Harmony daily for 24 weeks. Each morning, about 1-2 hours after their first meal, they will mix and consume 3 droppers full of Elix Daily Harmony and 6 droppers full of Elix Cycle Balance in water at room temperature or warm. There is no placebo or comparison group, and all participants receive the same herbal supplements throughout the study. During the trial, participants will complete validated questionnaires at baseline and at regular intervals (Week 4, 8, 12, 16, 20, and 24) to assess the severity of fibroid-related symptoms and changes in quality of life. Researchers will monitor symptom changes and quality of life domains through these scheduled assessments. The total participant involvement lasts 24 weeks, with no additional treatment or follow-up periods beyond this timeframe.

Researchers are examining new clinical, therapeutic, and prognostic findings to improve treatment models and develop a new algorithm for therapy in patients with uterine neoplasms, including cervical cancer, endometrial cancer, and uterine sarcoma. This observational study focuses on both operable and inoperable uterine malignancies to optimize predictive and therapeutic approaches. The study is sponsored by University Hospital Tuebingen and aims to enhance understanding and management of these cancers. The study involves analysis of circulating tumor cells (CTC) and disseminating tumor cells (DTC), detection of Human Papilloma Virus (HPV), Douglas cytology, DNA analysis in blood, proteomic analysis, and sentinel lymph node detection. These diagnostic tests are conducted to gather detailed information about the tumors and their spread. Participants with operable tumors may undergo laparoscopic, robot-assisted, or open radical gynecological surgery as part of their primary therapy. Participants will be involved in various assessments over a 12-month period, including cytology, proteomic, and DNA analyses, as well as urodynamic tests measuring nerve conduction velocity, cystomanometry, urethral pressure profiles, and uroflowmetry before and after surgery. These evaluations help monitor treatment effects and disease progression. The study requires participants to provide informed consent and to be willing and able to complete all study-specific procedures during the observation period.

Uterine fibroids are benign smooth muscle tumors of the uterus that are part of a broader group including malignant tumors with varying severity. Magnetic resonance imaging (MRI) is commonly used to differentiate fibroids from malignant tumors, but it has limitations that can lead to inappropriate treatment. This study aims to validate a new minimally invasive biopsy technique called ultrasound-guided transuterine vaginal biopsy (BVTE) to improve preoperative diagnosis and avoid unnecessary or harmful surgeries for uterine smooth muscle tumors. The procedure involves performing the BVTE under general anesthesia on the day scheduled for myomectomy or hysterectomy. The biopsy targets the center of the tumor via a transuterine route to reduce the risk of spreading cancer cells, taking 4 to 5 samples per tumor with a maximum of three tumors sampled. After the biopsy, patients undergo the planned surgery during the same operation, and all surgical specimens are sent for anatomopathological analysis. Participants will be assessed through anatomopathological comparison of the biopsy samples with the reference surgical specimens throughout the study period of 43 months. Researchers will monitor intraoperative and postoperative complications using the Clavien-Dindo classification. This study evaluates the feasibility, safety, and diagnostic accuracy of the BVTE technique as part of current clinical practice for women requiring surgical treatment for uterine smooth muscle tumors.

Researchers are collecting Real-World Data (RWD) to study the ongoing safety and effectiveness of the anovo Surgical System during transvaginal gynecological laparoscopic surgeries. They are also evaluating how the anovo Skills Development Pathway affects surgeon behavior and performance, focusing on the learning curve and procedure outcomes across surgeons with different experience levels. The study aims to minimize bias by including a broad patient population. The study involves surgeons using the anovo Surgical System, an endoscopic instrument control device designed to assist in controlling instrument arms during single site, natural orifice laparoscopic-assisted transvaginal benign gynecological surgeries. The study collects data on surgery times and adverse device events, while tracking surgeon competency development through the Skills Development Pathway. Participants will be patients undergoing gynecological surgery with the anovo Surgical System. Researchers will collect data on conversion rates to other surgical approaches and monitor for unanticipated adverse device effects up to 8 weeks post-surgery. Patients will also complete post-operative questionnaires to provide additional information. This observational registry study provides ongoing safety and performance data to understand device use in real-world settings.

Researchers are evaluating the impact of Transvaginal Natural Orifice Transluminal Endoscopic Surgery (vNOTES) compared to conventional abdominal laparoscopy (CAL) for benign adnexal surgery in women aged 18 to 70. The study aims to confirm that vNOTES does not negatively affect women's sexual function after surgery, addressing concerns about vaginal scarring and its effects on sexual activity. Secondary goals include assessing vNOTES efficiency, complications, and the quality of histological analysis of surgical specimens. Participants will be randomly assigned to receive either the vNOTES or CAL surgical technique for procedures such as cystectomy, oophorectomy, salpingectomy, or tubal sterilization. Both approaches involve minimally invasive surgery, with vNOTES using the vaginal route and CAL using abdominal laparoscopy. The study also examines pain, hospital stay length, patient satisfaction, and surgical complications during and up to 30 days after surgery. Women in the study will complete questionnaires before surgery and at 3 and 6 months afterward to assess sexual function, couple satisfaction, and pain during sex. Medical and general data will be collected at enrollment, during hospitalization, and one month post-surgery. The main outcomes measured include quality of sexual life and postoperative recovery, while monitoring safety and the effectiveness of both surgical methods throughout the study period.

This research aims to understand awareness, knowledge, and help-seeking behaviors related to gynecological problems among women in Hong Kong. It focuses on patients with conditions like PCOS, endometriosis, miscarriage, or infertility, as well as the general public. The study addresses cultural and social factors that may influence women's health behaviors, especially where Western and Chinese values intersect and where health literacy may be limited. Participants include two groups: gynecological patients aged 13 to 60 who have used or plan to use medical services for their conditions, and women aged 13 to 60 from the general public recruited online. Both groups will complete questionnaires designed to evaluate their understanding and behaviors regarding gynecological health issues. The study compares these groups to identify differences and barriers in seeking care. During the study, participants will provide information through questionnaires that explore their knowledge and actions related to PCOS, endometriosis, miscarriage, and infertility. Researchers will look at how social and cultural factors affect these behaviors over about one year. The study is observational, with no treatment involved, and aims to inform future strategies to improve women's health outcomes in Hong Kong.