Adenomyosis

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 studying women with dysmenorrhea, a condition involving painful periods, to see if they have a stronger musculoskeletal and autonomic nervous system response to painful internal stimuli compared to women without this pain. The study also aims to explore how interoceptive awareness, or the ability to sense internal body signals, might affect this relationship. This investigation seeks to better understand pain perception and related body changes in women with this condition. The study involves two groups: women with moderate to severe menstrual pain and age-matched controls with mild or no pain. Participants will attend two sessions: one for information and preparation, including tracking their menstrual cycle and heart rate variability (HRV) daily for 30 days, and a lab session where they will receive a controlled visceral pain stimulus. During the lab visit, hip mobility and muscle strength will be measured before and after the pain stimulus, and HRV will be recorded throughout. Participants will fill out questionnaires, perform daily HRV measurements with a phone app, and attend a lab session where detailed physical and physiological assessments occur. The study will measure changes in hip range of motion, muscle strength, and heart rate variability immediately after the pain stimulus. It will also assess interoceptive awareness during testing. The total participation includes daily monitoring for about a month and a single lab visit, with safety and comfort maintained throughout.

Researchers are evaluating the safety, tolerability, pharmacokinetics, and preliminary anti-tumor activity of a novel oral drug called NKT3964 in adults with advanced or metastatic solid tumors. The study aims to find the recommended dose for further testing and to observe how the drug affects various types of advanced cancers, including ovarian, endometrial, gastric, lung, and breast cancers, particularly those with specific genetic markers like CCNE1 amplification. The study has two main phases: Dose Escalation and Dose Expansion. In the Dose Escalation phase, participants receive increasing doses of NKT3964 to assess safety, side effects, and appropriate dosing. The Dose Expansion phase uses the recommended dose from the first phase to further evaluate the drug’s anti-tumor activity in specific tumor types. Both phases involve oral administration of the study drug, with detailed criteria for patient eligibility based on cancer type, prior treatments, and genetic markers. Participants will undergo regular assessments including physical exams, laboratory tests, imaging scans, and tumor biopsies before and during treatment. Researchers will monitor drug levels in the blood, treatment side effects, and tumor responses using standard criteria over periods ranging from one month to two years. The study also tracks progression-free survival, overall survival, and other measures to understand the drug’s impact and safety profile. Participation involves ongoing monitoring and follow-up visits throughout the study duration.

Researchers are investigating the role of immune factors in infertile women diagnosed with adenomyosis, a condition where endometrial tissue grows into the muscular wall of the uterus. This observational study aims to understand how immune cells and molecules in the blood may affect infertility associated with adenomyosis and to find potential targets for clinical intervention to improve pregnancy outcomes. The study is sponsored by Peking University Third Hospital and follows patients undergoing in vitro fertilization-embryo transfer (IVF-ET). Participants include women aged 18 to 40 with regular menstrual cycles who have adenomyosis diagnosed by specific ultrasound criteria. The study involves collecting peripheral blood on the day of embryo transfer, and if pregnancy is confirmed at 14 days, further blood samples are collected at 21 days and every two weeks thereafter until 12 weeks of gestation. Clinical information such as age, body mass index, infertility details, hormone levels, uterine volume, and embryo transfer characteristics are also recorded. Throughout the study, researchers monitor pregnancy outcomes including clinical pregnancy rate within 10 weeks after embryo transfer, miscarriage rate within 24 weeks, and live birth rate within one year. Secondary measures include analysis of immune cells and molecules in the blood during the first 12 weeks of pregnancy. This involves regular follow-up and blood collection to explore immune changes. The total duration of participation varies depending on pregnancy status and follow-up timing.

This research aims to understand whether changes seen in adult women with period pain also occur in adolescent girls within the first few years of having periods. It focuses on how quickly these changes happen and how period pain might contribute to other chronic pain types. This observational clinical cohort study explores these questions to help inform clinical practice and potentially develop prevention strategies. Participants are divided into two groups based on their reported period pain intensity: those with pain rated 4 or higher out of 10 and those with pain rated 3 or lower out of 10, with no other chronic pain conditions. No treatments are given during the study. Data collection occurs during specific menstrual cycle phases (days 1-3 and days 10-12) and includes questionnaires, nerve function tests, stress response assessments, brain imaging, and bladder sensitivity evaluations. During the study, participants complete detailed questionnaires and undergo tests such as Quantitative Sensory Testing, heart rate monitoring, bladder sensitivity measurement, salivary cortisol profiling, and brain scans. These assessments occur at specified menstrual phases to measure pain sensitivity, stress response, and brain function. The study helps researchers understand the progression of changes related to period pain and its link to chronic pain development over time.

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 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 two different protocols for preparing the uterus lining (endometrium) before frozen embryo transfer (FET) in women with adenomyosis undergoing IVF/ICSI. The study aims to find out if combining GnRH agonist and letrozole with hormone therapy leads to higher live birth rates compared to hormone therapy alone. It also looks at the side effects of the combined protocol. Adenomyosis, a condition where uterine tissue invades muscle layers, can cause infertility and pregnancy complications, and optimal preparation methods are unclear. Participants are randomly assigned to one of two groups. The first group receives two doses of GnRH agonist injections and daily letrozole over two months before starting hormone therapy with oral estradiol and vaginal progesterone. The second group receives hormone therapy alone starting early in the menstrual cycle with oral estradiol followed by vaginal progesterone once the uterine lining is thick enough. Embryo thawing and transfer are timed with progesterone start. Hormonal support continues until the 12th week of pregnancy. Participants undergo screening and ultrasound to confirm adenomyosis and monitor uterine lining thickness. Various pregnancy outcomes, including live birth rate at 22 weeks, pregnancy tests, implantation, miscarriage, and birth weight, are tracked. Side effects from the treatments and pregnancy complications like gestational diabetes and hypertension are also monitored. The study includes careful follow-up until delivery and newborn health assessments. Total participation duration covers preparation, pregnancy monitoring, and birth outcomes.

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.