Clinical Research Directory

Exercise Programs in Women With PCOS

This study aims to investigate the effectiveness of a digital rehabilitation-supported combined exercise program in women with Polycystic Ovary Syndrome (PCOS). Participants aged 18-40 years will be randomly assigned to one of three groups: a digital rehabilitation group, a face-to-face exercise group, and a physical activity counseling group. The intervention will last 8 weeks, with exercise performed three times per week. Outcomes will include DNA methylation, hormonal and metabolic parameters, anthropometric measurements, body composition, muscle strength, basal metabolic rate, physical activity level, quality of life, menstrual cycle regularity, exercise adherence and satisfaction.

Metformin Versus Myo-inositol in the Management of Polycystic Ovarian Disease: A Comparative Study

In polycystic ovary syndrome (PCOS), changes in physical appearance i.e. weight gain, hirsutism, menstrual disturbances and infertility result in reduced quality-of-life. PCOS is one of the most common endocrine disorders affecting about 4% to 8% of women of reproductive age. Diagnosis is primarily clinical with Rotterdam criteria being the most commonly followed criteria, which require the presence of two out of the three criteria including oligo and/or anovulation, clinical and/or biochemical signs of hyperandrogenism and polycystic ovaries on ultrasound. The objective of this study is to compare the outcome of Metformin versus Myo-inositol in the management of polycystic ovarian disease.

Clinical Investigation of Herbal Formulation and Its Efficacy in Polycystic Ovarian Syndrome

Polycystic Ovarian Syndrome (PCO) is a metabolic disorder that afflicts the women of childbearing age. An approximate of 5-10% women are the victim of this disorder. PCOS is a leading cause of infertility in females these days and is characterized by Hyperandrogenism, Chronic Anovulation, Impaired fertility, obesity, Hirsutism, Acne, Obesity, Metabolic disturbances (dyslipidemias, Hyperinsulinemia, insulin resistance, and type- 2 diabetes), and Endometrial Hyperplasia. This study will test a combination of herbal medications (Melats P) in women with PCOS to determine which works best to overcome infertility.

Continuous Glucose Monitoring in Polycystic Ovarian Syndrome

The purpose of this study is to learn more about blood sugar control in polycystic ovarian syndrome. The patient will be asked to wear a continuous glucose monitor (CGM) device that is applied to the arm with a sensor or filament that goes under the skin to measure your sugar levels. The patient will wear this at certain time points throughout the study. There will have a total of 2 blood draws (about 1 tsp. of blood) at screening and the 6-month visit, a measure of the patients body muscle and fat (body composition), and fill out a questionnaire at the end of the first 3 months and 6 months. Study participation in the research will last about 6 months.

Effects of Wet-Cupping on Polycystic Ovary Syndrome Patients

The goal of this clinical trial is to evaluate whether wet cupping therapy (Hijama) can improve reproductive and metabolic outcomes in women diagnosed with Polycystic Ovary Syndrome (PCOS). This study will be conducted among female participants aged 20-40 years who have been diagnosed with PCOS according to the Rotterdam criteria. The main questions it aims to answer are: Can wet cupping therapy regulate menstrual cycles in women with PCOS? Can it increase the pregnancy rate in married participants with PCOS-related infertility? Researchers will compare outcomes between a wet cupping group and a control group to determine whether Hijama has significant effects on reproductive, hormonal, and metabolic markers. Participants will: Undergo screening and eligibility evaluation using a checklist Be randomized into either the wet cupping (intervention) or control group Receive lifestyle counseling (diet and physical activity) For the intervention group: Receive one Hijama session performed by a certified practitioner Undergo follow-up at 4 and 12 weeks for clinical, hormonal, and ultrasound assessments For all participants: Complete laboratory tests, ultrasound scans, and questionnaires on PCOS symptoms and quality of life Report any side effects during and after the study period

Time Restricted Feeding Model in Women With Polycystic Ovary Syndrome

This study aims to evaluate the effects of a 16:8 time-restricted feeding (TRF) model on anthropometric, metabolic, and hormonal parameters in women with polycystic ovary syndrome (PCOS). In addition, the study will assess participants' food preferences, nutrient intake, and gastrointestinal hormone responses, alongside serum glucose, insulin, and glucagon levels, during ad libitum breakfast meals served at the beginning and end of the intervention. The study consists of three groups: women with PCOS following a 16:8 TRF model for 12 weeks, women with PCOS following an energy-restricted diet for 12 weeks, and healthy women following a 16:8 TRF model for 12 weeks. Women aged 18-40, with PCOS based on the Rotterdam criteria, will be included in the PCOS groups, while those without PCOS-related symptoms will form the control group. Exclusion criteria include pregnancy, lactation, use of hormonal medications, and the presence of comorbidities such as diabetes or severe liver/kidney dysfunction. Participants in the TRF groups will consume their daily caloric intake within an 8-hour eating window, fasting for the remaining 16 hours, while the energy-restricted group will follow a balanced diet without timing restrictions. Adherence to the dietary interventions will be monitored through weekly 24-hour dietary records. At baseline, participants will complete a demographic questionnaire, receive nutritional education for their nutritional plan, and undergo assessments for anthropometric and blood pressure measurements, sleep quality, food cravings, and physical activity. Biochemical analyses will evaluate thyroid and sex hormones, electrolytes, liver enzymes, lipid profiles, and hemograms. Additionally, all participants will wear smart wristbands (FitBit Charge 5) throughout the study to track sleep and physical activity. At the beginning and end of the study, participants will consume a standardized ad libitum breakfast meal during the early follicular phase (days 2-5 of menstrual bleeding). Participants will have 30 minutes to eat as much as they wish, and their consumption will be recorded by a dietitian. The nutrient content of the consumed foods will be analyzed using the Nutrition Information System (BEBIS) software. Blood samples will be collected and visual analogue scala (VAS) will be filled at fasting and at 30, 60, 90, and 120 minutes post-meal. Serum glucose, insulin, glucagon, ghrelin, and incretin hormones will be analyzed using the enzyme-linked immunosorbent analysis (ELISA) method. Data analysis will be performed using SPSS 23.0 via appropriate statistically analysis. Statistical significance is set at p\<0.05.

Effects of Aerobic Exercise Training Program in Females With Insulin Resistant Polycystic Ovarian Syndrome

Design: RCT Randomized Clinical Trial Non Probability Convenient Sampling Technique Duration of treatment: 25 weeks 2 groups; (group A=30) SSAET +Normal routine medication+ Normal Dietary Plan , Other group (Group B=30) with normal routine medication + Normal Dietary Plan. Patients will be enrolled in experimental group according to speeds test. HYPOTHESIS: Alternate hypothesis: There is difference on the effects of Supervised Structured Aerobic Exercise Training Program on serum BDNF, androgens level, menstrual irregularity and quality of life in females with insulin resistant polycystic ovarian syndrome. Null Hypothesis: There is no difference on the effects of Supervised Structured Aerobic Exercise Training Program on serum BDNF, androgens level, menstrual irregularity and quality of life in females with insulin resistant polycystic ovarian syndrome. OBJECTIVES: To determine the effects of Supervised Structured Aerobic Exercise Training Program on quality of life in women with PCOS. 2\. To determine the effect of Supervised Structured Aerobic Exercise Training Program on BDNF levels in women with PCOS. 3\. To determine the effect of Supervised Structured Aerobic Exercise Training Program on mental health (stress, depression, anxiety) in women with PCOS. 4\. To determine the effect of Supervised Structured Aerobic Exercise Training Program on BMI in women with PCOS. 5\. To determine the effect of Supervised Structured Aerobic Exercise Training Program on menstrual irregularity in women with PCOS. 6\. To determine the effect of Supervised Structured Aerobic Exercise Training Program on Aerobic fitness in women with PCOS. 7\. To determine the effect of Supervised Structured Aerobic Exercise Training Program on androgens level in PCOS. 8\. To determine the effect of Supervised Structured Aerobic Exercise Training Program on Lipid accumulation product in PCOS. 9\. To determine the effect of Supervised Structured Aerobic Exercise Training Program on Glycemic control in PCOS.

Effect of Theronomic Ova-All Care on Biomarkers of Ovarian Health in Adult Female With Polycystic Ovarian Syndrome

Theronomic Ova-All Care is a tribiotic health product aimed at improving ovarian health in people with polycystic ovarian syndrome (PCOS). In this study, a total of 16 participants with PCOS diagnosed by a gynaecologist will be invited to take Ova-All Care, two capsule once a day, for 12 weeks. Biomarkers of ovarian health will be measured at baseline, four weeks after the start of the intervention, and at the end of the intervention.

Comparative Study Between HOMA1-IR and HOMA2-IR in Prediction of Ovulation Outcome in Women With PCOS

122 women diagnosed with PCOS seeking fertility in the fertility clinic at kasr Alainy hospital will be subjected to Homeostatic model assessment for insulin resistance 1 was calculated for all participants through the equation \[glucose (mmol/L) × insulin (µU/L)\]/22.5 while homeostatic model assessment for insulin resistance 2 was calculated by the HOMA2 calculator. All women will be subjected to induction of ovulation using the Aromatase inhibitor Letrozole 2.5 mg tab twice daily from the 3rd day of the cycle for 5 days . Ultrasound follow up of follicular growth will be performed till dominant follicular size reaches 18-22 mm. FSH preparations will be introduced as needed.

Comparison of Pregnancy Outcomes in Women with Polycystic Ovarian Syndrome with and Without Glucophage

The goal of this clinical trial is to learn if Glucophage (metformin) improves pregnancy outcomes in women with polycystic ovarian syndrome (PCOS). It will also evaluate the safety of Glucophage during pregnancy. The main questions it aims to answer are: Does Glucophage reduce the risks of early pregnancy loss, preterm delivery, and gestational diabetes? Are there any medical problems associated with taking Glucophage during pregnancy? Researchers will compare Glucophage with standard care (diet and exercise) to see if it improves pregnancy outcomes in women with PCOS. Participants will: Take Glucophage or follow a standard diet and exercise plan throughout pregnancy. Attend regular follow-up visits for checkups, ultrasounds, and blood tests. Have their pregnancy outcomes, such as fetal growth and gestational diabetes, recorded.

Polycystic Ovarian Syndrome (PCOS) Biomarker Evaluation Study

The purpose of the study is to validate recently identified biomarkers for the identification of PCOS in adolecent and young adult women.