Menstrual Disorder

This research aims to evaluate knee joint position sense, pain, and dynamic balance in females with primary dysmenorrhea, a common menstrual condition affecting many adolescent girls and women of reproductive age. The study is observational and focuses on young adult females aged 18 to 25 years. It addresses a gap in understanding how primary dysmenorrhea impacts physical therapy-relevant factors such as knee joint function and balance. Participants will be grouped based on their dysmenorrhea severity: those with no or mild symptoms and those with moderate to severe symptoms. There is no intervention applied during the study; instead, measurements are taken to compare these groups. The study observes participants during their menstrual cycle at specific times to assess balance and knee joint sense. During the study, researchers will measure overall stability indexes including antero-posterior and medio-lateral stability, as well as knee joint position sense and pain on the first and fourth days of menstruation. These assessments will help understand the effects of primary dysmenorrhea on physical balance and knee function. The total study duration includes these menstrual cycle assessments, with no additional intervention or treatment.

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 studying how serum kisspeptin levels change throughout pregnancy in women with polycystic ovary syndrome (PCOS). This study aims to understand the relationship between kisspeptin, insulin, glucose, and testosterone levels, and to explore whether kisspeptin can predict gestational diabetes mellitus (GDM) and other pregnancy complications in PCOS patients. The study is observational and focuses on pregnancies affected by PCOS using the 2003 Rotterdam diagnostic criteria. The study includes two groups: pregnant women aged 18 to 40 diagnosed with PCOS before pregnancy, and healthy pregnant women in the same age range without PCOS. Participants will be registered for prenatal check-ups during the first trimester. This is an observational study, so no specific treatments or interventions will be given. Researchers will monitor kisspeptin and related hormone levels at different stages of pregnancy. Participants will be followed throughout pregnancy, with assessments to measure dynamic changes in serum kisspeptin over 40 weeks. The study will also evaluate how kisspeptin levels relate to the development of GDM and insulin resistance. Participants will undergo regular check-ups, laboratory tests, and hormone measurements. The study will help understand hormonal changes in PCOS pregnancies and their potential impact on complications, with a total participation time covering the full pregnancy period.

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 effectiveness and safety of rimegepant for intermittent prevention of menstrual migraine in women who experience migraine attacks related to their menstrual cycles. This Phase 3, double-blind, randomized study focuses on women aged 18 to 45 years with a history of menstrual migraine. The study is sponsored by Pfizer and aims to compare rimegepant with placebo in reducing migraine days during the perimenstrual period. Participants will be assigned to receive either rimegepant 75 mg orally disintegrating tablets (ODT) for 7 consecutive days during the perimenstrual period or a matching placebo for the same duration. Additionally, rimegepant may be used for acute migraine treatment as needed, alongside a standard of care option for acute treatment. The study includes a 5-month double-blind treatment phase covering five menstrual cycles. During the study, participants will be monitored for changes in the number of migraine days and headache days during the 5-day perimenstrual period, as well as changes in the use of acute migraine medications. Assessments will also include migraine severity and functional disability, cognitive effects, and monthly migraine and headache days normalized to 28-day cycles. Safety and efficacy will be tracked throughout the study, which is expected to last through March 2027.

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.

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 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 effectiveness of acupuncture compared to metformin, both combined with lifestyle management, in improving glucose control in women with insulin resistance and polycystic ovary syndrome (PCOS). The study aims to see if these treatments improve ovulation, hormone balance, quality of life, and symptoms of anxiety and depression, while also investigating if acupuncture has fewer side effects. They also explore whether these treatments can reverse molecular changes that may help prevent type 2 diabetes. Participants will be randomly assigned to one of three groups: lifestyle management alone, lifestyle management plus acupuncture, or lifestyle management plus metformin. Acupuncture treatments involve inserting sterile needles into specific abdominal and leg acupuncture points related to ovarian and pancreatic function, administered three times weekly for four weeks, then twice weekly for twelve weeks. Metformin is taken orally, starting at a low dose and gradually increasing to 1500 mg daily over 16 weeks. All women receive lifestyle advice on weight management, diet, and exercise at the start. During the study, participants undergo assessments at the start, after 4 months of treatment, and again 4 months post-treatment. These include blood tests measuring insulin sensitivity, glucose levels, hormone levels, and molecular markers from tissue samples. Researchers will also monitor menstrual patterns, ovulation, quality of life, mental health symptoms, eating habits, and treatment side effects. The study lasts 8 months with ongoing evaluations to determine the cost-effectiveness and overall impact of each treatment approach.