Adenomyosis

Researchers are collecting real-world data on the Cerene Cryotherapy Device, which was approved by the FDA in 2019 for treating heavy menstrual bleeding in premenopausal women who have completed childbearing. This observational study aims to compare outcomes from routine clinical use of the Cerene device with results from previous pivotal studies, helping to understand its effectiveness and safety in everyday practice. Participants in this registry will have received treatment with the Cerene device as part of their standard medical care. The study does not involve any additional active interventions beyond this treatment. Data collection includes patient and physician surveys covering demographics, quality of life, procedural details, and clinical outcomes following the Cerene treatment. Women will participate for about 13 months, starting from enrollment and continuing through a 12-month follow-up after treatment. During this time, surveys will be completed at multiple points to assess re-intervention rates, quality of life, site of service, physician feedback, and cost analysis. The study concludes after the last participant completes her one-year follow-up visit.

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 drugs 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 drugs 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 investigating the effectiveness of two different methods for preparing the uterus lining before frozen embryo transfer in women with adenomyosis undergoing IVF or ICSI. Adenomyosis is a benign condition where tissue normally lining the uterus grows into its muscle, causing infertility and other complications. This randomized clinical trial seeks to determine if combining a GnRH agonist and letrozole with hormone therapy leads to a higher live birth rate compared to hormone therapy alone. Participants are randomly assigned to one of two groups. One group receives pre-treatment with two doses of a GnRH agonist and daily letrozole before starting an artificial cycle with oral estradiol valerate and vaginal progesterone. The other group receives only the artificial cycle hormone treatment without pre-treatment. Embryos are thawed and transferred based on progesterone timing, and hormone support continues through early pregnancy. The trial also evaluates side effects of the pre-treatment and analyzes future babies health and cost-effectiveness. During the study, participants undergo screenings including ultrasound and hormone level tests. Endometrial thickness is monitored, and embryo transfer is performed under ultrasound guidance. Researchers measure outcomes such as live birth rate, pregnancy rates, side effects, pregnancy complications, and newborn health. The study follows participants through pregnancy up to birth and records various fetal and maternal outcomes. Participation lasts from screening through treatment and follow-up until delivery.

Researchers are evaluating patient-reported pain, bleeding, and the efficiency of devices used during intrauterine device IUD insertions. This trial compares a new FDA-approved, atraumatic suction cervical stabilizer called Carevix with the standard single-tooth tenaculum, which is considered more traumatic. The study also looks at provider satisfaction and ease of use for these devices, focusing on differences in pain scores between patients who have never given birth nulliparous and those who have multiparous. Participants will be randomly assigned to receive either the Carevix device or the standard tenaculum during their IUD insertion procedure. Providers will perform the procedures using the assigned device, and participants will complete surveys about their pain experience and satisfaction immediately after the procedure. The study collects additional information on cultural background, previous contraceptive use, and reasons for choosing IUD insertion or anticipating removal. During the trial, participants will be evaluated for pain at several points before the procedure, during cervix grasping and traction, at IUD placement, and five minutes after completion. Providers will assess ease of device use, number of placement attempts, bleeding, and overall satisfaction right after the procedure. Patient satisfaction and bleeding cessation time will also be measured. The study runs from March 2026 to March 2027, with ongoing assessments during and immediately after the IUD insertion.

Researchers are studying the potential effects of a high-cannabidiol CBD sublingual product on gynecologic pain in individuals with endometriosis, adenomyosis, or chronic pelvic inflammatory disease PID. This clinical trial is double-blind, placebo-controlled, and focuses on understanding specific targets and mechanisms of a hemp-derived, full-spectrum, high-CBD product for managing these conditions. Participants will be randomly assigned to receive one of two doses of the high-CBD product or a placebo. The study involves self-administration of the assigned product three times daily for one week. A subset of participants may undergo additional pharmacokineticpharmacodynamic studies involving extended blood sampling and questionnaires to better understand the bodys response to the CBD product. During the study, participants will attend three visits including screening, baseline, and final visits. These visits include clinical interviews, medical screenings, urine and blood sample collections, questionnaires, and sensory testing. Researchers will measure levels of CBD and its metabolites, inflammatory markers, and circulating anandamide at the start and end of the study. Participants will track their product use and may receive additional compensation if participating in extended procedures. The study aims to assess treatment effects over the 7-day period.

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 womens 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.