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PCOS clinical trials

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NCT ID: NCT06143527 Recruiting - Clinical trials for Polycystic Ovary Syndrome

Safety of Cultured Allogeneic Adult Umbilical Cord Derived Mesenchymal Stem Cells for PCOS

Start date: November 16, 2023
Phase: Phase 1
Study type: Interventional

This trial will study the safety and efficacy of cultured allogeneic adult umbilical cord derived mesenchymal stem cells delivered intravenously for the treatment of Polycystic Ovary Syndrome.

NCT ID: NCT06124261 Recruiting - NAFLD Clinical Trials

Androgens and NAFLD Longitudinal Cohort Study

Start date: January 1, 2024
Phase:
Study type: Observational [Patient Registry]

The researchers want to learn how androgens, a type of sex hormone, might affect nonalcoholic fatty liver (NAFLD) in young women over time. NAFLD happens when fat builds up in the liver which can cause damage to the liver such as inflammation or scarring. Young women with a condition called polycystic ovary syndrome (PCOS) have a high risk for NAFLD, and they often have high androgen levels too. So the researchers are recruiting young women with PCOS as well as those without PCOS, and will compare changes in NAFLD over time between young women with and without PCOS. This study is funded by the National Institutes of Health

NCT ID: NCT06101147 Recruiting - PCOS Clinical Trials

Effect of Vitamin D Supplementation on Testosterone Level in Women With Polycystic Ovary Syndrome

Start date: September 21, 2023
Phase: Phase 2
Study type: Interventional

The goal of this randomized, double blind, placebo-controlled clinical trial is to learn about, the effect of low dose vitamin D supplementation compares with placebo-controlled group on testosterone level in women with polycystic ovary syndrome. Half of Participants will receive vitamin D and metformin while other half placebo and metformin.

NCT ID: NCT06072287 Recruiting - Obesity Clinical Trials

The Living With a Long-Term Condition Study

LTC
Start date: June 28, 2023
Phase:
Study type: Observational

Psychological distress (anxiety and depression) is common in and experienced differently by people living with long-term health conditions (LTCs). Being able to measure whether psychological distress is related to living with a LTC would allow researchers and clinicians to provide interventions specifically tailored to the challenges of living with a LTC and therefore provide the most appropriate support for these patients. Such a measure would also be useful in research to identify the presence of illness-related distress in different patient groups. This project will therefore create a new measure of illness-related distress that has applications for both research and clinical practice. This will involve the psychometric validation of the new illness-related distress measure to test how valid and reliable the measure is. The aim of the project is to provide initial validation of the Illness Related Distress Scale in a community sample, recruited through online platforms. The objective of the study is to gather initial validity and reliability data for the scale.

NCT ID: NCT05979389 Recruiting - NAFLD Clinical Trials

Bicalutamide Therapy in Young Women With NAFLD and PCOS

Start date: January 1, 2024
Phase: Phase 1
Study type: Interventional

Nonalcoholic steatohepatitis (NASH), or fat-related liver inflammation and scarring is projected to be the leading cause of cirrhosis in the United States (U.S.) within the next few years. Women are at disproportionate risk for NASH, with approximately 15 million U.S. women affected. There is an urgent need to understand risk factors for NASH and its progression in women, and sex hormones may provide a missing link. This study will study the contribution of androgens to liver injury and progression in PCOS and mechanistic role of dysregulated lipid metabolism and visceral adiposity in this process. Such findings will provide the rationale for future efficacy studies evaluating selective androgen receptor (AR) antagonism for NASH in PCOS, or alternatively, the need to directly target visceral adiposity or lipid-specific pathways as part of a precision medicine approach to halt fibrosis progression in the nearly 5 million young women with PCOS and NAFLD in the U.S., who remain at increased risk for early onset and progressive liver disease.

NCT ID: NCT05971849 Recruiting - Clinical trials for Polycystic Ovary Syndrome

Dampening the Reproductive Axis With Continuous Kisspeptin

Start date: October 6, 2023
Phase: Phase 1
Study type: Interventional

The goal of this study is to assess response to kisspeptin as well as the baseline patterns of luteinizing hormone (LH) secretion in individuals with polycystic ovarian syndrome (PCOS).

NCT ID: NCT05958914 Recruiting - PCOS Clinical Trials

Neuropeptide Expression During the Ovarian Cycle and in Patients With PCOS

PCO-NP
Start date: July 1, 2023
Phase: N/A
Study type: Interventional

The goal of this clinical trial is to characterize PCOS in terms of neuropeptide expression and to make the comparison between women with and without PCOS by going to analyze venous blood samples taken during the three phases of the ovarian cycle and follicular fluid, taken during the ovulatory phase as part of the oocyte pick-up. Specifically, the expression of neuropeptides such as CGRP, SP, VIP and enkephalins in the three phases of the ovarian cycle (follicular phase, ovulatory phase and luteal phase) will be evluated in three groups of women afferent to the medically assisted reproduction centre. In particular, Group 1 (control) will include women with regular ovarian cycle; Group 2 will include non-PCOS women undergoing ovarian stimulation and ICSI treatment; finally Group 3 will include women with PCOS undergoing ovarian stimulation and ICSI treatment. The main question[s] it aims to answer are: - Is there a fluctuation in blood neuropeptides concentrations of women with normal ovarian cycles during the three phases of the ovarian cycle? - Do PCOS women has altered levels of blood and follicolar fluid concentration of neuropepides with respect to non-PCOS individuals? - Is blood and follicolar fluid concentration of neuropeptide modulated by protocols of ovarian stimulation? Participants of Group 1 will follow the ovarian monitoring protocol, during which blood samples will be taken at the three phases of the ovarian cycle. Participants of Group 2 and 3 will undergo ovarian stimulation and ICSI treatment, followed by blood and follicular fluid sampling at the specified cycle phases. Researchers will compare the control Group 1 with Group 2 and 3 to see if there is a significative difference in the concentration of blood neuropeptides between the three groups at the same phase of the ovarian cycle. Moreover, they will evaluate if there is there significant different concentration of neuropeptides in follicolar fluid between group 2 and 3 during the ovulatory phase.

NCT ID: NCT05872425 Recruiting - PCOS Clinical Trials

Efficacy and Safety of Dingkundan Combined With Combination Oral Contraceptives in the Treatment of PCOS

Start date: February 1, 2023
Phase: N/A
Study type: Interventional

This is a single-center, non-randomized, open-label clinical study to investigate the efficacy and safety of Dingkundan (DKP) combined with compound oral contraceptives (COC) in the treatment of PCOS. This study is mainly to compare the effect of COC plus DKP verse COC on reducing androgen, improving the function of ovarian and the individual metabolism. The secondary objective of our study is to explore the efficacy of DKP on pregnancy in patients with PCOS and its safety.

NCT ID: NCT05864690 Recruiting - PCOS Clinical Trials

Anxiety Disorders, Depression and Related Factors in PCOS

Start date: May 8, 2023
Phase:
Study type: Observational

Polycystic ovary syndrome (PCOS) is a systemic neuro-endocrine-metabolic-reproductive disorder, common in women of reproductive age, affecting 21.27% of women worldwide and the rate of PCOS has been increasing over the past decade. Women with PCOS have many health problems, including insulin resistance, hyperandrogenemia, and ovulation disorders. Moreover, PCOS is also associated with significant consequences such as increased risk of cardiovascular disease, glucose intolerance and diabetes mellitus (both type 2 and gestational), increased risk of endometrial hyperplasia and endometrial cancer and mental health disorders. A meta-analysis of 57 studies has been reported that women with PCOS are more likely to have an increased risk of diagnosis of depression, anxiety, bipolar disorder, and obsessive-compulsive disorder. These psychological disorders may be related to biometric and biochemical characteristics in women with PCOS, such as body image, hirsutism or acne. Furthermore, researches showed that waist-to-hip ratio and plasmatic levels of testosterone is inversely related to anxiety, psychoticism, hostility and to the indexes of psychological distress. Psychological consequences may also be related to other factors, including stigmatization and isolation, the lack of empathy from family and friends, the feeling of guilt and the diminished sense of self-worth, the costs of treatment and treatment outcomes. However, there has been no data on the psychological disorders in infertile women with PCOS. Therefore, the study aimed to determine the prevalence of anxiety disorders, depression in infertile women with PCOS and associated factors.

NCT ID: NCT05762822 Recruiting - PCOS Clinical Trials

Exogenous Ketone Ester in Women With Polycystic Ovary Syndrome.

Start date: May 10, 2023
Phase: N/A
Study type: Interventional

Polycystic ovarian syndrome (PCOS) is characterized by elevated androgens such as testosterone. Clinical studies suggest that ketogenic diets lower the levels of androgens. The ketone 3-hydroxybutyrate (3-OHB) may play an important role in these effects and the main purpose of this study is to investigate whether a 3-OHB supplement acutely improves the hormonal and metabolic status in women with PCOS.