Endometriosis

This research aims to evaluate a gender-transformative intervention designed to reduce intimate partner violence (IPV) against infertile women. It focuses on couples diagnosed with female-factor infertility undergoing their first or second IVF or ICSI cycle. The trial addresses the overlap between infertility and IPV, recognizing that infertile women face higher risks of IPV and that their needs have often been overlooked. Participants are randomly assigned to one of two groups. The intervention group receives five 60-minute sessions led by trained nurses and social workers throughout the fertility treatment cycle. These sessions cover gender norms, gender equality, and healthy relationship skills at key treatment stages: before the cycle starts, during follicular monitoring, before oocyte retrieval, two weeks after embryo transfer, and 28-30 days post-transfer. The control group receives standard reproductive care. A total of 376 couples will participate, split evenly between the two groups. During the study, couples will undergo assessments at baseline and multiple points up to about 14 months after delivery. Researchers will measure the rate of IPV against infertile women over the past 12 months as the primary outcome. Secondary assessments include IPV against male partners, attitudes toward gender roles, marital quality, coping with stress, patient satisfaction with treatment, pregnancy outcomes, and neonatal health. This comprehensive follow-up includes questionnaires, clinical pregnancy tests, and monitoring of birth outcomes to understand the intervention's impact over time.

Researchers are exploring a new non-invasive method to select embryos during assisted reproductive technology treatments such as IVF and ICSI. This study evaluates an integrated approach combining artificial intelligence-enhanced morphokinetic (MK) analysis using time-lapse imaging and Raman spectroscopy (RS) of the spent culture medium to improve embryo assessment. The goal is to increase the clinical pregnancy rate by accurately identifying embryos with chromosomal abnormalities without the need for invasive genetic testing. The study has two phases. Phase I is a retrospective study collecting data to train the AI model combining MK and RS methods. Phase II is a prospective randomized controlled trial where participants are assigned to one of two groups: embryos selected by the MK-RS integrated method or embryos selected by traditional morphological assessment by embryologists. Embryo images are captured every 10 minutes, and spent culture medium is analyzed by RS to detect metabolic markers. The MK-RS method aims to complete embryo assessment within 5-6 days after fertilization. Participants will undergo IVF/ICSI treatment with embryo culture using a time-lapse incubator. Researchers will collect images and culture medium samples to analyze embryo development and metabolic profiles. The main outcome measured is the clinical pregnancy rate at 6-8 weeks of gestation. Secondary outcomes include miscarriage rate, multiple pregnancy rate, ploidy status, and live birth rate. The study involves monitoring embryo development, collecting biological samples, and evaluating pregnancy outcomes through follow-up.

Researchers are evaluating the effects of vipoglanstat on non-menstrual pelvic pain (NMPP) related to endometriosis in women aged 18 to 44 years. This Phase 2 trial aims to assess how well vipoglanstat works and its safety in treating moderate to severe pain caused by endometriosis. The study is sponsored by Gesynta Pharma AB and is designed as a randomized, double-blind, placebo-controlled trial.

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.

Researchers are evaluating GenSci048 for treating moderate to severe pain associated with endometriosis in pre-menopausal women. This randomized, double-blind, placebo-controlled Phase IIa study aims to assess the safety and effectiveness of GenSci048 in relieving endometriosis-related pain. The study is sponsored by Changchun GeneScience Pharmaceutical Co., Ltd. and focuses on women aged 18 to 49 who have been diagnosed with endometriosis within the past 10 years. Participants will receive either GenSci048 or a placebo by subcutaneous injection every four weeks. The treatment period includes regular dosing and monitoring over several months. Researchers will compare changes in pain levels, including menstrual pain and non-menstrual pelvic pain, using a numeric rating scale from baseline through week 24 and up to 52 weeks for secondary outcomes. During the study, participants will attend scheduled visits for assessments of pain, use of rescue medications, and overall health evaluations. Safety will be monitored through adverse event reporting for up to approximately 56 weeks. Pain changes will be measured with standardized scales, and participants will be asked about their impressions of change at multiple time points. Total participation may last over one year, including treatment and follow-up periods.

Researchers are evaluating a dietary intervention in women with endometriosis to see if it improves pain and quality of life. This randomized, controlled study compares the effects of a whole food plant-based diet against continuing a usual diet over 12 weeks. The study aims to understand how diet may affect symptoms in women diagnosed with endometriosis. Participants are randomly assigned to either follow the whole food plant-based diet or remain on their usual diet for the 12-week period. The study includes two groups: one receiving the dietary intervention and the other serving as a control group continuing their normal eating habits. The intervention is monitored throughout the study duration to assess its impact. During the study, participants will attend visits and follow procedures to track their health and adherence to the assigned diet. Researchers will measure total pain scores after 12 weeks as the primary outcome. Participants will also be monitored for safety and compliance during the study period, which lasts approximately three months.

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 efficacy and safety of Jincaopian Tablets for treating chronic pelvic pain in women who have had pelvic inflammatory disease. This phase III clinical trial aims to address the significant burden of chronic pelvic pain, a common complication following pelvic inflammatory disease, by comparing Jincaopian Tablets to a placebo in a well-controlled study environment. Participants are randomly assigned in a 2:1 ratio to receive either Jincaopian Tablets or a placebo. Those in the Jincaopian group take 0.6 grams daily for 12 weeks, while the placebo group receives an identical regimen. After completing the treatment period, all participants enter a 4-week follow-up period to assess ongoing effects. During the study, researchers will monitor pain disappearance rates at 12 weeks as the primary outcome. Secondary measures include pain scores over time, quality of life assessments, and evaluations of physical signs related to pain. Safety is closely monitored through reports of adverse events. Participants will be regularly assessed throughout the 16-week total study duration to understand treatment impact and safety.

Endometriosis is a common gynecological disease affecting women of reproductive age, causing pain, masses, and infertility. The exact cause of endometriosis is unclear. Researchers are examining the relationship between endometriosis and the microbiota found within tissue to better understand this condition. This observational study compares women diagnosed with endometriosis to those without it, often having other benign gynecologic conditions like uterine fibroids or teratomas. Participants will have samples collected before surgery, including blood serum, vaginal swabs, cervical mucus, and feces. During surgery, if possible, additional samples such as peritoneal fluid and both eutopic and ectopic endometrial tissue will be taken. These samples will undergo various sequencing methods like microbiota, transcriptome, metabolome, and single-cell sequencing to analyze microbial composition and related mechanisms. During the study, participants will be evaluated through surgical confirmation and biopsy analysis. Researchers will measure the composition of intra-tissue microbiota using metagenomics next-generation sequencing over a three-year period. The study includes detailed sample collection and laboratory experiments to explore the microbiota's role in endometriosis, with participation lasting from screening through surgical and laboratory procedures.

This observational study aims to understand how force feedback instruments are useful during surgeries performed with the da Vinci 5 robotic system. It focuses on procedures such as inguinal and ventral hernia repairs, colorectal, thoracic, gynecologic surgeries, and partial nephrectomy. The study is designed to gather information on how these instruments perform during robotic-assisted surgery. Participants will undergo multi-port robotic-assisted surgery using the da Vinci 5 system equipped with force feedback instruments, which provide tactile sensations. The study observes surgeries planned as primary procedures with these instruments, without altering the treatment. There is no experimental drug or placebo involved, as this is an observational study conducted after the devices have been marketed. During the study, researchers will measure the force applied to tissues by the force feedback instruments during surgery and evaluate how useful these instruments are during specific steps of the procedure before patient discharge. Participants will be followed up as per the study protocol to ensure data quality. The total participation time varies depending on the surgical procedure and follow-up schedule.