Clinical Research Directory

Inositol Supplementation to Treat PCOS (INSUPP-PCOS)

To determine if Inositol, a dietary supplement, will improve ovarian and adrenal androgen excess in women with Polycystic Ovarian Syndrome(PCOS).

The Combined Effect of N-Acetyl Cysteine and Metformin in Polycystic Ovary Syndrome Patients

The study aims to evaluate the effects of combination of metformin with NAC in PCOS on biochemical and hormonal parameters.

Chinese Overweight/Obesity Cohort: Metabolic & Comorbidity Risks

This is a nationwide, multi-center, long-term follow-up study of overweight and obese adults in China. The study aims to recruit approximately 26,000 participants across 39 hospitals to better understand how body weight affects the development of obesity-related diseases over a 3-year period. Eligible participants are adults aged 18 to 79 years with a body mass index (BMI) of 23 kg/m² or higher. Participants will be grouped into four categories based on their BMI: overweight, mild obesity, moderate obesity, and severe obesity. At the beginning of the study, all participants will undergo a comprehensive health assessment, including physical measurements, body composition analysis, blood tests, and lifestyle questionnaires. Participants will then be followed for 3 years with annual check-ins to track any new health conditions. The main goal is to identify the 3-year risk of developing conditions such as type 2 diabetes, fatty liver disease, high blood pressure, and heart disease in different weight groups. This information will help doctors better predict and prevent obesity-related health problems in the future. Participation is voluntary, and all personal information will be kept confidential.

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

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

The Effect of Lifestyle Program Women With PCOS

Polycystic Ovary Syndrome (PCOS) is a common hormonal condition affecting women of reproductive age. In addition to physical symptoms such as irregular menstruation, hormonal changes, and changes in body weight, women with PCOS may experience increased stress, difficulties in maintaining healthy lifestyle behaviors, and reduced quality of life. Lifestyle behaviors, including healthy eating, physical activity, and stress management, may play an important role in improving overall well-being among women with PCOS. This study examined the effect of a structured Lifestyle Modification Program on stress, healthy eating habits, health-promoting lifestyle behaviors, and PCOS-related quality of life among women diagnosed with PCOS. The program was based on the 5A's model: Assess, Advise, Agree, Assist, and Arrange, and was culturally adapted for women with PCOS. A total of 30 women with PCOS participated in the study. Participants were recruited from the Gynecology Department of Allied Hospital II, Faisalabad, and were placed into an experimental group (n = 15) or a control group (n = 15). The experimental group participated in a structured lifestyle modification program delivered through four sessions over two weeks. The program focused on healthy dietary practices, physical activity, stress management, and strategies for maintaining healthy lifestyle behaviors. The control group continued with routine clinical care. Participants completed assessments before and after the intervention. Measures assessed perceived stress, healthy eating habits, health-promoting lifestyle behaviors, and PCOS-related quality of life. The study was conducted to determine whether a structured lifestyle modification program could contribute to improvements in psychological well-being, healthy lifestyle behaviors, and quality of life among women with PCOS. The findings may help inform the integration of psychological and lifestyle-based interventions into the care of women with PCOS.

Time-Restricted Eating as a Dietary Intervention for Polyendocrine Metabolic Ovarian Syndrome (PMOS): Protocol for a Randomized Controlled Trial

Polyendocrine Metabolic Ovarian Syndrome (PMOS), previously known as PCOS, is a common endocrine disorder associated with metabolic, reproductive, and hormonal abnormalities. Growing evidence suggests that time-restricted eating (TRE) may improve body weight regulation, insulin sensitivity, hormonal balance, and menstrual function in women with PMOS. However, the mechanisms underlying these benefits remain unclear, particularly regarding the role of the gut microbiota and neurohormonal pathways. This randomized controlled trial will investigate whether combining an 8-hour TRE regimen with Healthy Eating Plate dietary recommendations provides greater benefits than dietary recommendations alone. Women aged 18-40 years with PMOS and overweight or obesity will participate in an 8-week intervention. The study will assess changes in gut microbiota composition, microbial metabolites, metabolic health, hormonal profile, neurohormonal markers, and body composition. The study is expected to provide novel insights into the interactions between meal timing, gut microbiota, neuroendocrine regulation, and clinical manifestations of PMOS, contributing to the development of more effective and sustainable dietary strategies for this condition.

Letrozole Versus Letrozole and Inositol

Polycystic ovary syndrome (PCOS) is one of the most common endocrine and metabolic disorders affecting women of reproductive age. Its prevalence varies considerably according to the population studied and the diagnostic criteria applied. A recent global systematic review and meta-analysis estimated the prevalence of PCOS among adult women to be approximately 12.1% according to the Rotterdam criteria, compared with 7.9% using the National Institutes of Health (NIH) criteria and 12.7% using the Androgen Excess-PCOS Society criteria.

Metabolic Responses of Metformin and Genetic Polymorphisms of SLC22A1 Gene in PCOS

The aim of this study is to see the associations of metabolic responses of metformin with single nucleotide polymorphisms (SNPs) (rs628031 and rs2282143) of solute carrier family 22 member 1 (SLC22A1) gene in women with polycystic ovary syndrome (PCOS). This prospective clinical study will be conducted in the department of Endocrinology, Bangabandhu Sheikh Mujib Medical University (BSMMU) from February 2023 to September 2024 over a period of two years. A total of at least 100 women with PCOS (18 - 35 years) diagnosed based on International Evidence-based Guideline for PCOS 2018, will be included consecutively by convenient sampling. After taking informed written consent, relevant clinical history will be taken and physical examinations will be done at baseline. Following a run in phase of three weeks, patients will visit thrice after 1, 12 \& 24 weeks of metformin maintenance therapy with a window period of 14 days both ways. Blood samples will be collected in fasting state at baseline and after 24 weeks of treatment to measure glycemic status, lipid profile, fasting insulin, c-peptide and detection of SLC22A1 gene (rs628031 and rs2282143) polymorphisms. Glucose will be measured by glucose oxidase method, lipids by glycerol phosphate dehydrogenase peroxidase method, insulin by chemiluminescent microparticle immunoassay, c-peptide by enzyme-linked immunosorbent assay (ELISA) and genetic analysis of rs628031 and rs2282143 by polymerase chain reaction-restriction fragment length polymorphism (PCR-RFLP).

NAFLD in Adolescents and Young Adults With PCOS

This project focuses on an at-risk adolescent and young adult population who may gain long-term health benefits from detection of risk factors at a young age. The primary aims of this proposal are: 1) To observe whether adolescents and young adults with Polycystic Ovary Syndrome (PCOS) are more likely to have elevated liver fat (\>/=4.8%) than controls by studying liver fat deposition measured by magnetic resonance spectroscopy (MRS); 2) To assess the association of percentage liver fat with biomarkers of Non-alcoholic fatty liver disease (NAFLD), dyslipidemia, insulin resistance and body composition in PCOS and controls. In the proposed study, 40 adolescents and young adults with PCOS and 40 age-comparable control subjects will be evaluated for metabolic disturbances and elevated liver fat using noninvasive and state-of-the-art techniques including MRI, dual-energy x-ray absorptiometry and an oral glucose tolerance test in order to fully assess the metabolic and body composition differences between these groups. This research proposal represents a critical step in understanding the metabolic and cardiovascular comorbidities of PCOS and their relationship to NAFLD. The investigator hopes to use the results generated by this research proposal in order to lay the groundwork for the prevention and treatment of metabolic disorders in adolescents with PCOS. The overarching goal is to decrease and prevent lifelong morbidity associated with this common disorder.

Inositol in Letrozol Resistant PCOS Women

Polycystic ovary syndrome (PCOS),is a complex neuro-endocrine disorder affecting approximately 5% to 10% of women in reproductive age.Inositols are considered insulin sensitizers, as they modulate the members of insulin signaling pathways.Thiss study compares between the effect of inositol and metformin in letrozol resistant PCOS women.

Metabolic and Hormonal Parameters in Women With Polyendocrine Metabolic Ovarian Syndrome

Polyendocrine Metabolic Ovarian Syndrome (PMOS) is a common endocrine and metabolic disorder associated with insulin resistance, hyperandrogenism, and an increased risk of long-term metabolic complications. Fetuin-A and resistin are adipokines implicated in insulin resistance and chronic inflammation and may serve as potential biomarkers for metabolic dysfunction in women with PMOS. This prospective observational case-control study aims to compare serum and salivary Fetuin-A and resistin levels between women with PMOS and healthy controls. The study will evaluate the correlation between serum and salivary biomarker concentrations and investigate their associations with insulin resistance, lipid profile, and hormonal parameters. The findings may help determine whether salivary measurements can serve as reliable non-invasive biomarkers for the diagnosis and metabolic assessment of PMOS.

Does Vaginal Delivery of Combined Hormonal Contraception Affect the Risk of Metabolic Syndrome in Overweight/Obese Women With PCOS

A prospective study to determine the metabolic effects of the contraceptive vaginal ring among overweight and obese women with polycystic ovary syndrome (PCOS). We will recruit a total of 40 participants and study use of the vaginal ring over a 4-month period.

Efficacy of Mazdutide for Treating PCOS

The goal of this clinical trial is to learn the efficacy of Mazdutide in treating obese female adults diagnosed with polycystic ovary syndrome (PCOS). The main question it aims to answer is: Does Mazdutide lower the free androgen index (FAI) in obese female adults with PCOS? Participants will take Mazdutide once every week for 24 weeks and visit the clinic once every 4 weeks for checkups and tests.

Effect of ALA Combined With Letrozole on Polycystic Ovary Syndrome Clinical Outcome in Infertile Females

This research study aims to investigate the effect of adding Alpha lipoic acid (ALA) supplement to letrozole treatment in infertile women with polycystic ovary syndrome (PCOS). The study will include 150 PCOS participants seeking fertility treatment. They will be randomly divided into two groups - control and intervention. Both groups will receive standard PCOS care including lifestyle counseling. The control group will be treated with letrozole only. The dose will start at (2.5 mg) for 5 days and can increase up to (7.5 mg) based on response. The intervention group will take ALA supplements along with letrozole treatment. ALA tablets (600mg) will be given three times daily starting from day 3 of the menstrual cycle till human chorionic gonadotropin (HCG) injection day. Letrozole dose for the intervention group will also follow the same incremental protocol as the control group. Patient monitoring will involve trans-vaginal ultrasound scans on certain cycle days to check follicle growth and the thickness of uterus lining. Once a follicle reaches 18mm in size, an intramuscular HCG injection will be given. Couples will be asked to have intercourse 36 hours after the injection. Pregnancy will be tested two weeks later if menstruation does not occur. Metabolic, hormonal, and ultrasound parameters will be recorded at baseline and follow-ups. All adverse effects of the treatment will be noted. The study period will be a maximum of 3 treatment cycles or untill pregnancy is achieved. Outcome measures include ovulation and pregnancy rates. The effect of ALA on metabolic parameters (fasting glucose, fasting insulin, BMI and HOMA-IR), hormone levels (mid-luteal progesterone and serum estradiol), and follicular growth will also be assessed. Proper sample size and randomization methods will be followed. A Statistical analysis of collected data will help determine if ALA has additional benefits when combined with letrozole for PCOS fertility treatment. Finally, the results will be statistically analyzed. Statistical analysis will be done using the SPSS statistical software package.

Body Fat as Determinant of Female Gonadal Dysfunction

Reproduction requires from women enough energy depots to warrant an adequate nutritional supply to the fetus. Hence, adipose tissue is able to communicate with female hypothalamic-pituitary-ovary axis. The hypothesis of the project is that abnormalities in the quantity (absolute and relative to lean body mass), distribution and/or function of adipose tissue are associated with functional forms of female gonadal dysfunction in predisposed women, in a spectrum of anomalies that go from hypothalamic amenorrhea to the polycystic ovary syndrome (PCOS). To challenge this hypothesis, the investigators will study 5 groups of 10 women each: women with exercise-associated hypothalamic amenorrhea, women without ovulatory dysfunction that exercise equally, non-hyperandrogenic patients with PCOS, hyperandrogenic patients with PCOS, and healthy control women comparable to those with PCOS. The aims of the study will be: Primary objective: To identify novel signalling factors originating from adipose tissue and muscle using targeted and nontargeted evaluation of the proteome and of gene expression of superficial subcutaneous fat, deep subcutaneous fat (which mimics visceral adipose tissue) and skeletal muscle. Secondary objectives: 1. To study the serum adipokine profile - including those identified by the primary objective - and circulating gut hormones during fasting and after a glucose load in the 5 groups of women, and their associations with sexual hormones and body fat distribution. 2. To study body composition and body fat distribution in these women and their relationships with: 2.1, Sex steroid profiles. 2.2. Classic cardiovascular risk factors: carbohydrate metabolism, lipid profiles and blood pressure. 2.3 Markers of low-grade chronic inflammation. 2.4. Oxidative stress markers. 2.5. Cardiovascular autonomic function. 2.6. Surrogate markers of subclinical atherosclerosis. 2.7. Circulating concentrations of endocrine disruptors. 2.8. Oral and gut microbiome. The results will provide a better understanding of the mechanisms linking body energy depots with the female reproductive axis and, hopefully, the identification of potential biomarkers for the diagnosis and treatment of the disorders studied here.

Multimodal Ocular Diagnosis-Guided Precision Acupuncture and Lifestyle Intervention for PCOS

This study is designed as a prospective, multicenter, parallel-group randomized controlled trial to evaluate the effectiveness of a "precision acupuncture + personalized lifestyle" intervention, guided by dynamic multimodal risk monitoring based on the four diagnostic methods of Traditional Chinese Medicine (TCM), in improving insulin resistance in patients with polycystic ovary syndrome (PCOS). Compared with "conventional acupuncture + standard lifestyle intervention," the study will primarily assess changes in the homeostatic model assessment of insulin resistance (HOMA-IR) after 12 weeks of treatment. The safety of the intervention, improvements in endocrine and metabolic profiles, menstrual and ovulatory outcomes, psychological status, quality of life, and health-economic outcomes will also be evaluated. The study aims to provide evidence for establishing an intelligent and individualized clinical management model for PCOS.

The Physiological Responses and Adaptation of Brown Adipose Tissue to Chronic Treatment With Beta3-Adrenergic Receptor Agonists

Background: Brown adipose tissue (BAT) is a type of fat in the body. It may prevent weight gain, improve insulin sensitivity, and reduce fatty liver. Researchers want to see if BAT helps the body burn energy. Objective: To learn more about how BAT works to burn energy. Eligibility: People ages 18-40 with a body mass index between 18 and 40 Design: Participants will be screened with: Medical history Physical exam Blood, urine, and heart tests Dietitian interview Participants will have an overnight baseline visit. This includes: Repeats of screening tests Exercise test Scans. For one scan, a radioactive substance is injected into the arm. FSIVGIT: An IV is inserted into veins in the right and left arms. Glucose and insulin are injected in one arm. Blood glucose and insulin levels are measured from the other. Metabolic suite: Participants stay 18-19 hours in a room that measures their metabolic rate. Monitors on the body measure heart rate, movement, and temperature. Optional fat biopsy: A small piece of tissue is removed with a needle. Participants will take 2-4 pills daily for 4 weeks. All women will take the drug mirabegron. Men will be randomly get either the drug or a placebo. All participants will have a visit after 2 weeks of the pills. They will repeat the screening tests. Participants will have an overnight visit 2 weeks later. They will repeat the baseline tests. Participants will keep food and medication diaries. Participants will have a follow-up visit 2 weeks after stopping the pills. This includes heart tests.

Acupuncture for Insulin Resistance in Women With Polycystic Ovary Syndrome

This two-stage clinical research programme aims to evaluate the preliminary effectiveness and safety of acupuncture for improving insulin resistance in women with polycystic ovary syndrome (PCOS). Phase I will be a prospective, single-centre, open-label, single-arm exploratory trial involving 20 participants, all of whom will receive active acupuncture plus lifestyle management. Acupuncture will be administered three times per week for 12 weeks, followed by a 12-week follow-up period. The study will primarily assess safety, tolerability, feasibility, and the preliminary change in the homeostatic model assessment of insulin resistance (HOMA-IR) from baseline to Week 12. The effect size and variability of HOMA-IR change, together with safety, adherence, and dropout data obtained from Phase I, will be used to determine the sample size and finalize the design of Phase II. Phase II is planned as a prospective, multicentre, parallel, randomized, participant- and outcome assessor-blinded, sham-controlled trial comparing active acupuncture plus lifestyle management with sham acupuncture plus lifestyle management to confirm the effectiveness and safety of the intervention.

The REBALANCE Study - a Prospective, Multicenter, Randomized, Pivotal Study of the May Health System

A Prospective, Multicenter, Randomized, Pivotal Study of the May Health System in Transvaginal Ablation of Ovarian Tissue under Ultrasound Guidance in Women with Infertility due to Polycystic Ovary Syndrome

Effect of Sitagliptin on Polycystic Ovarian Syndrome Patients

The Study aims to determine the proposed positive influence of Sitagliptin in manipulating hormonal , metabolic and inflammatory parameters in the treatment of Polycystic ovary syndrome and subsequent infertility

Myo-Inositol for Ovarian Stimulation and ICSI Outcomes in Women With PCOS

Polycystic ovary syndrome (PCOS) is a common endocrine disorder that may affect ovarian function, insulin sensitivity, and fertility. Myo-inositol has been proposed as an insulin-sensitizing supplement that may improve metabolic and reproductive outcomes in women with PCOS. This randomized, double-blind clinical trial evaluated the effect of myo-inositol supplementation on controlled ovarian stimulation and assisted reproductive technology (ART) outcomes in women with PCOS undergoing in vitro fertilization (IVF) and/or intracytoplasmic sperm injection (ICSI). A total of 88 participants were randomly assigned to two parallel groups. The intervention group received myo-inositol combined with folic acid, while the control group received folic acid alone for 3 months before the ART cycle and until the day of oocyte retrieval. The study assessed whether myo-inositol could improve metabolic and hormonal parameters, ovarian response to stimulation, oocyte and embryo quality, and pregnancy outcomes, while also evaluating ovarian hyperstimulation syndrome (OHSS).

Evaluation of the Venous Thrombotic Biological Profile of Different PCOS Phenotypes: French Cross-sectional Study

Polycystic ovary syndrome (PCOS) is the most common endocrine disorder of women of childbearing age. PCOS can be individualized into several phenotypes, taking into account in particular the presence of hyperandrogenism, insulin resistance and BMI. Hyperandrogenism and insulin resistance appear to be important factors in the development of cardiovascular cardiovascular disease. In addition, patients frequently use anti-androgenic and/or contraceptive treatments contraceptives, such as combined hormonal contraception (CHC), the use of which is associated with an increased cardiovascular and thrombo and venous thrombosis (VTE). A meta-analysis published in 2020 by Gariani et al. based on three large studies, estimated the risk of VTE in women with PCOS after adjustment for obesity and hormone therapy. This risk was significantly higher compared with women without PCOS (pooled OR 1.89, CI95% 1.60-2.24). No study has looked specifically investigated the risk of VTE according to different PCOS phenotypes. Such data would be very useful in clinical practice, as it would enable monitoring, contraceptive treatment and anti-androgenic anti-androgen treatment according to the PCOS phenotype, while limiting risks. Assessing the differences PCOS phenotypes is limited by the large sample size required. required. VTE is a rare event in women of childbearing age, and the number of PCOS phenotypes is high. PCOS phenotypes. Intermediate markers of VTE risk are used in these situations. These markers are thrombin generation tests (notably ETP) and their sensitivity to activated protein C (nAPCsr) and thrombomodulin (nTMsr), as well as sex-hormone binding globulin (SHBG).

Identification of Women With Severe Insulin Resistant Syndromes of Genetic Origin Among Patients With "Classic" Polycystic Ovary Syndrome (PCOS)

Diagnostic case-control study (1 case for 2 controls). Inclusion of patients with severe insulin resistance syndrome of genetic origin, then inclusion of controls: patients examined for PCOS in day hospital with matching age (+/- 5 years) and Body mass index (+/- 5kg/m2).

Effect of Orlistat on Metabolic and Hormonal Features in Women With Polycystic Ovary Syndrome (PCOS): a Randomized Controlled Clinical Trial

This randomized controlled clinical trial aims to evaluate the effect of orlistat on the metabolic and hormonal features of women with polycystic ovary syndrome (PCOS). Eligible women diagnosed with PCOS according to the Rotterdam criteria will be randomly assigned to receive either orlistat plus standard lifestyle advice or placebo plus standard lifestyle advice for three months. The study will assess the effect of orlistat on hormonal parameters, glucose metabolism, lipid profile, liver function, anthropometric measures, non-alcoholic fatty liver disease, and quality of life to determine its effectiveness as an adjunctive treatment for women with PCOS.