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Polycystic Ovary Syndrome clinical trials

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NCT ID: NCT06192381 Completed - PCOS Clinical Trials

Effect of Web-Based Module on Nursing Students' Knowledge, Practice and Attitude Regarding Polycystic Ovary Syndrome

Start date: December 11, 2022
Phase: N/A
Study type: Interventional

Background: Polycystic ovary syndrome (PCOS) is a heterogeneous endocrinopathy among reproductive-aged women that has become a major international public health concern. Objective: Investigate the effect of web-based health education module on nursing students' knowledge, adaptive healthy measures and attitude regarding polycystic ovary syndrome. Research design: A two-armed, single-blind, parallel groups prospective randomized controlled trial (RCT), with a baseline pre-test and immediate post-test was used to carry out this study. Setting: The study was conducted at the Faculty of Nursing, Mansoura University, Egypt in December 2022 to May 2023. Subjects and sampling: Simple random sampling technique was employed to recruit the study subjects. Data collection: A questionnaire was developed to acquire data including six parts.

NCT ID: NCT06192147 Not yet recruiting - Clinical trials for Polycystic Ovary Syndrome

The Phenotype and Clinical Intervention of High BCAA Type of PCOS

BCAAPCOS
Start date: January 1, 2024
Phase: N/A
Study type: Interventional

Polycystic ovary syndrome is one of the main diseases leading to infertility in women of childbearing age. In addition to endocrine and reproductive dysfunction, it is often accompanied by significant metabolic abnormalities, which seriously affect long-term health and quality of life. Our preliminary research found that 68% of PCOS patients have significantly increased branched chain amino acid content, accompanied by a decrease in clinical pregnancy rate and an increase in miscarriage rate, which poses challenges to the diagnosis and treatment of PCOS. Based on this, we propose a new PCOS typing strategy that uses the concentration of branched chain amino acids as an evaluation indicator to diagnose high branched chain amino acid PCOS, where the serum BCAA concentration is higher than 405 μ Mol/L is diagnosed as high branched chain amino acid PCOS. According to the different degrees of elevation of branched chain amino acids, they are further divided into common type and ultra-high type, and the impact of different concentrations of branched chain amino acids on pregnancy outcomes, pregnancy complications, and newborns after assisted reproductive technology is analyzed; Based on the typical clinical and metabolic phenotypes of high branched chain amino acid type PCOS patients, corresponding intervention strategies are formulated. By analyzing the clinical pregnancy outcomes, pregnancy complications, and neonatal conditions of patients in the combination intervention group (protein restricted diet combined with vitamin D supplementation) and the conventional treatment group, safe and effective intervention methods are determined.

NCT ID: NCT06184412 Completed - Clinical trials for Periodontal Diseases

Periodontal Status and Endothelial Dysfunction in Patients With Polycystic Ovary Syndrome

Start date: February 1, 2020
Phase:
Study type: Observational

Emerging research indicates a link between polycystic ovary syndrome (PCOS) and periodontal diseases, revealing the intricate relationship between oral health and systemic conditions. PCOS, a hormonal disorder in women of reproductive age, often associates with obesity, dyslipidemia, and insulin resistance, heightening the risk for type 2 diabetes (T2D) and cardiovascular disease (CVD). The pathogenesis of PCOS involves an inflammatory response marked by increased CRP, inflammatory cytokines, elevated blood leukocytes, adhesion molecule expression, and oxidative stress markers like myeloperoxidase (MPO). Periodontal diseases, bacterial infections affecting gums, ligaments, cement, and bone, include gingivitis (gum inflammation) and periodontitis (irreversible tissue destruction). Evidence suggests a link between periodontitis and increased CVD risk, while such association with gingivitis is limited. Potential mechanisms linking periodontal diseases and CVD involve cytokine release, oral bacteria toxin production, and direct bloodstream transfer. Recognition of lipopolysaccharide (LPS) and TNFα triggers innate immune cells via TLR4 and TNFR, activating NF-κB and JNK expression. JNK amplifies inflammatory responses, inducing proinflammatory genes, and TNFα, IL-1, IL-6, and IL-8 can invade endothelial layers, promoting adhesion molecule expression. Enhanced leukocyte ROS production, especially in periodontitis, contributes to endothelial dysfunction and heightened cardiovascular risk. The activation of multiple inflammatory pathways likely links PCOS, periodontal disease, and increased cardiovascular risk. Thus, the researchers aim to investigate if the presence of periodontal diseases, particularly gingivitis, exacerbates oxidative stress, inflammation and atherosclerosis surrogate markers in women with PCOS, and explore the underlying molecular mechanisms.

NCT ID: NCT06170463 Completed - Clinical trials for PCOS (Polycystic Ovary Syndrome) of Bilateral Ovaries

Insulin Sensitizers Role in Control of PCOS Vicious Cycle.

Start date: August 1, 2022
Phase: Phase 1
Study type: Interventional

PCOS is a common and complex disease affecting women of reproductive age. It is characterized by its complex pathological symptoms and mechanisms resulting in endocrine and metabolic dysfunction. PCOS is highly associated with various metabolic and endocrinal disorders. Metformin is mainly used for its glucose-lowering effects for treatment and prevention of type-2 diabetes mellitus (DM), gestational DM, and PCOS. Myo-inositol (MI) protects against MAFLD through reduction of hepatic accumulation of triglycerides.

NCT ID: NCT06169566 Not yet recruiting - Clinical trials for PCOS- Polycystic Ovary Syndrome

The Synbiotics Effects in Polycystic Ovary Syndrome: A Randomized Controlled Trial

PCOS
Start date: January 1, 2024
Phase: N/A
Study type: Interventional

The goal of this clinical trial is to compare the effect of synbiotics and placebo in Thai women with polycystic ovary syndrome. The main questions it aims to answer are: - Do synbiotics have a positive effect on the gut microbiome? - Do synbiotics have a positive effect on reproductive outcomes? - Do synbiotics have a positive effect on cardiovascular outcomes? Participants will be randomized, and blinded to receive either synbiotics or placebo. While placebo is a comparison group: Researchers will compare with placebo to see if the effects on reproductive and cardiovascular risk differ.

NCT ID: NCT06167135 Recruiting - Obesity Clinical Trials

Polycystic Ovary Syndrome, Mitochondrial Dysfunction, Obesity, Insulin Resistance Infertility (POMODORI) Cohort

POMODORI
Start date: September 10, 2021
Phase:
Study type: Observational [Patient Registry]

Enrolling of 150 female patients of fertile age diagnosed with PCOS, insulin resistance, infertility, or mitochondrial disease, and the same number of age- and sex-matched controls are planned. During the research biomarkers already with mitochondrial dysfunction in the scientific literature and common mtDNA abnormalities (deletions, point mutations, copy number changes, etc.) are examined.

NCT ID: NCT06164132 Completed - Obesity Clinical Trials

Pivotal Influence of Obesity on Body Composition and Ovarian Doppler in Different Polycystic Ovarian Syndrome Phenotypes

Start date: July 1, 2023
Phase:
Study type: Observational

The study aimed to explore the impact of obesity on both body composition and ovarian Doppler parameters across various phenotypes of females diagnosed with polycystic ovarian syndrome (PCOS). Additionally, the investigation seeked to establish correlations between these parameters and their prevalence concerning the clinical criteria of PCOS.

NCT ID: NCT06158932 Completed - Clinical trials for Polycystic Ovary Syndrome

A Single Group Study to Evaluate the Effects of a Myo-Inositol and D-Chiro Inositol Supplement on Symptoms Associated With Polycystic Ovary Syndrome and Hormone Imbalance

Start date: September 8, 2023
Phase: N/A
Study type: Interventional

This is a virtual single group study that will last 12 weeks. 40 female participants will take 4 capsules of the Optify Myo Inositol and D-Chiro Inositol Plus Folate and Vitamin D supplement per day. Questionnaires will be completed at Baseline, Week 4, Week 8 and Week 12. Participants will also provide a waist circumference measurement at Baseline and Week 12.

NCT ID: NCT06155708 Not yet recruiting - PCOS Clinical Trials

Exogenous Ketone Supplementation in Females With Polycystic Ovary Syndrome

Start date: January 2024
Phase: N/A
Study type: Interventional

Polycystic ovary syndrome (PCOS) affects 1 in 5 females of reproductive age. Commonly characterized as a disorder of infertility, PCOS is often accompanied by 3 potent cardiovascular disease (CVD) risk factors: insulin resistance, endothelial dysfunction, and elevated blood pressure. Accordingly, PCOS is associated with the development of CVD, the second leading cause of death in females in Canada. However, effective treatments to improve cardiovascular health in PCOS are lacking. Exogenous ketone monoester (KME) ingestion has been shown to improves outcomes associated with insulin resistance, endothelial function, and blood pressure regulation in healthy individuals and individuals predisposed to CVD. Therefore, oral ketone supplements offer a practical and effective strategy for improving cardiovascular health; however, this treatment has yet to be evaluated in PCOS. Therefore, the overall goal of this project is to employ KME ingestion to improve markers of cardiovascular health in females with PCOS. On two different days, participants will consume either a beverage containing a ketone supplement or a beverage containing a placebo supplement. The objectives are to compare responses between KME and placebo ingestion, and examine all outcomes related to cardiovascular health in females with PCOS in comparison with female controls of similar age and body mass index. The effects of KME ingestion will be quantified on: 1) glycemic control during an oral glucose tolerance test; 2) endothelial function using the flow-mediated dilation test; 3) blood pressure and acute blood pressure regulation; and 4) hemodynamic responses to acute exercise.

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.