Symptoms and General Pathology

All Conditions

Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Gland and Hormone Related Diseases

Syndrome

Polycystic Ovary Syndrome

Cysts

Ovarian Cysts

Ovarian Diseases

Adnexal Diseases

Genital Diseases, Female

Genital Diseases

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Gonadal Disorders

Endocrine System Diseases

Lipid Regulating Agents

All Drugs and Chemicals

Simvastatin

Anticholesteremic Agents

Hypolipidemic Agents

Antimetabolites

Hydroxymethylglutaryl-CoA Reductase Inhibitors

Enzyme Inhibitors

20 mg/day,po,for two months until the day of hCG injection placebo pills as like as simvastatin will be used

SIMVASTATIN

batool hossein rashidi, MD

The purpose of this study is to determine whether simvastatin is effective in the improvement of IVF-ICSI outcome in Pcos patients.

simvastatin reduces cardiovascular risks by improving hypercholesterolemia, reducing vascular smooth muscle proliferation, ameliorating inflammation, limiting theca-interstitial proliferation \& decreasing steroidogenesis (production of progesterone \& testosterone).Polycystic ovary syndrome (pcos) is associated with increased cardiovascular risks and is characterized by ovarian theca-interstitial hyperplasia\& hyperandrogenism .This study will test the hypothesis that simvastatin improves biochemical parameters\& IVF-ICSI outcome in Pcos patients.

Effects of Simvastatin on Biochemical Parameters and Outcome of IVF-ICSI in Pcos Patients

Effects of Simvastatin on Biochemical Parameters and Outcome of IVF-ICSI in Pcos Patients : A Prospective Randomized Double Blind Placebo Controlled Trial

Tehran University of Medical Sciences

Akabr Fotouhi

For the group allocated with exercise, high intensity circuit training (HICT) of three supervised sessions per week for 20-30 mins will be given. HICT commenced after 10 mins low to moderate intensity warm up and after completing session ended with 10 mins cool down. Intensity of exercise will be measured on borg rating of perceived exertion (RPE). Perceived exertion is how hard you feel like your body is working. Although this is a subjective measure your exertion rating based on a 0 to 10 modified borg rating scale may provide a fairly good estimate of your actual heart rate during physical activity. 0 perceiving "no exertion at all" to 10 perceiving a "maximal exertion" of effort. A moderate intensity activity will be at 3-5 perceiving "somewhat hard", similarly 6-10 will be perceived as high intensity activity.

For the group allocated with intermittent fasting, a time restricted feeding (TRF) methodology will be administered. The Fasting protocol will begin with a 12-hour eating window (12:12) and will gradually go down to 8 hours eating window over a period of 8 weeks (16:8).

The group allocated with both exercise and intermittent fasting will be provided with both HICT for three sessions per week and 8 hours' time restricted eating.

High Intensity circuit training consisting of circuits of high intensity exercises and progressed up to 8 weeks will be provided.

High Intensity Circuit training (HICT)

Time restricted feeding will be used in which the intervention will begin with a 12:12 window leading to a 16:8 IF protocol.

Intermittent Fasting (IF)

The participants will follow both HICT and IF for 8 weeks.

Combination of HICT and IF

Imran Amjad, PhD

Sarah Ehsan, PP-DPT

Hafsa Javed, DPT

The goal of this randomized controlled trial is to compare the effects of High intensity circuit training, Intermittent Fasting, and their combination on PCOS morphology, Anthropometrics, clinical hyperandrogenism and body image concerns in females with PCOS.

Participants will be divided into three groups who will receive High intensity circuit training, Intermittent fasting and their combination. The outcomes will be PCOS morphology, anthropometrics', clinical hyperandrogenism and body image concerns.

Effects of HICT and Intermittent Fasting on PCOS

Effects of High Intensity Circuit Training and Intermittent Fasting on Polycystic Ovarian Syndrome

Changes from baseline PCOS morphology on the ultrasound will be done by calculating the number of follicles and measuring follicle size. For this purpose, ultrasound imaging is the best option as it is both harmless and inexpensive. PCOS is considered if on ultrasound imaging there are 12 or more than 12 follicles in the ovary and has size of 2-9 mm or volume of 10 cm 3 .

Changes from baseline Weight (kg) will be measured by weight scale while height (ft) will be measured by stadiometer. BMI will be calculated by dividing your weight in kilograms (kg) by your height in meters squared (m 2 ). Waist Circumference (WC) will be measured in centimeters, between the costal margin and the pelvic brim, and Hip Circumference (HC) will be measured in cm at the level of the symphysis pubis by inches tape.

Changes from baseline Modified Ferriman Gallwey (mFG) score will be used to assess the hirsutism as a measure of clinical hyperandrogenism.

Changes from baseline Body Image concerns will be measured using The BSQ which is a self-reported measurement of the body shape concerns designed for women to measure concerns about body image problems.

Riphah International University

Nutritional and Metabolic Diseases

Insulin Resistance

Vitamin D Deficiency

Hyperinsulinism

Metabolic Diseases

Glucose Metabolism Disorders

Avitaminosis

Deficiency Diseases

Malnutrition

Nutrition Disorders

Hypoglycemic Agents

Bone Density Conservation Agents

Micronutrients

Vitamins

Insulin

Insulin, Globin Zinc

Vitamin D

Cholecalciferol

Vitamin D3

Calciferol

Polycystic ovary syndrome (PCOS) female patients. 20-35 years of age.

Non-PCOs female subjects. 20-35 years of age.

Sara S Youssef, MD

Sherif A Ashoush, Phd, MD

Hisham M Fathi, Phd, MD

The primary aim of the current study is to clarify whether serum vitamin D levels \[25(OH)D3\] have a temporal association with insulin resistance and/or insulin sensitivity in PCOS women versus healthy ones.

To achieve this aim, the investigators will conduct a prospective observational study involving obese and lean PCOS women in comparison to obese and lean healthy subjects living in Cairo, Egypt.

Polycystic ovary syndrome (PCOS) is the most common gynecological endocrinopathy among women of reproductive age. The prevalence of PCOS among such women is estimated to be 6.4% to 6.8% worldwide. PCOS is a heterogeneous androgen excess disorder with different degrees of reproductive and metabolic dysfunctions.

There are many considerations to explain the complexity of the underlying pathogenesis of PCOS, particularly the well-known roles of hypothalamic-pituitary gonadal dysfunctions, metabolic abnormalities and genetic factors, the developmental model of chronic diseases postulates that early-life events affect the individual differences in vulnerability to lifestyle and environment, suggesting that hostile intrauterine environment and low birth weight may predispose to the development of early adrenarche, PCOS and metabolic syndrome later in life; however, the definite pathogenesis and real underlying etiologies of PCOS remain uncertain and ripe with opportunities for further research.

PCOS is the most common cause of anovulatory infertility, and its foremost clinical symptoms include anovulation or oligo-ovulation, infertility, menstrual irregularity, polycystic ovaries, and hyperandrogenism in women without specific underlying diseases of the adrenal or pituitary glands. A primary abnormality in folliculogenesis may have played a role in the development of PCOS. The polycystic ovaries contain multiple antral follicles, some of which prematurely acquire LH receptors and become responsive to LH, increasing granulosa cell proliferation in the preantral follicles, resulting in anovulation. PCOS is defined by the presence of having at least 2 of the following criteria: irregular or absent ovulation, elevated levels of androgenic hormones, and enlarged ovaries containing at least 12 follicles each.

Several epidemiological and interventional PCOS studies demonstrate that serum vitamin D concentrations are inversely associated with fasting plasma glucose levels, insulin resistance, body mass index (BMI), and body fat contributing to the pathogenesis of PCOS by promoting insulin resistance and affecting glucose metabolism in PCOS women. Vitamin D is either produced in the skin in response to direct exposure to sunlight from dehydrocholesterol or obtained from the diet. Vitamin D3 (cholecalciferol) is converted into 25-hydroxyvitamin D3 principally in the liver and 1,25-dihydroxyvitamin D3 in the kidney by two hydroxylation steps. 1,25-dihydroxyvitamin D3 is an active form of vitamin D, it binds to vitamin D receptors (VDRs) that are expressed in 2776 genomic positions and modulate the expression of 229 genes in more than 30 different tissues, such as the skeleton, pancreatic islet cells, parathyroid glands, and ovaries.

About 3% of the human genome are regulated by VDRs gene including those responsible for glucose and fat metabolism as well as blood regulation; it's active form acts through its VDRs either directly or through regulation of intercellular calcium that facilitates insulin secretion. It has been suggested that Vitamin D increases insulin sensitivity through the effect on its muscle cell receptors by increasing insulin receptors or increasing the insulin sensitivity of insulin receptors to insulin. Also, being a fat soluble vitamin, a higher proportion of vitamin D may be sequestered in the adipose tissue of obese individuals, resulting in lower 25-(OH)D3 concentration levels; therefore, a low vitamin D status is suspected to be a risk factor for impaired glucose tolerance, insulin resistance and a substantial cause of obesity.

In the light of the literature, the relationship between vitamin D status and insulin or glucose metabolism has been investigated in women with PCOS who are vitamin D deficient, although there is no consensus on whether or not serum vitamin D levels are different in women with or without PCOS. Vitamin D level is defined as a serum level of 25-hydroxycholecalciferol \[25-(OH)D3\]. Vitamin D insufficiency is defined as a 25-(OH)D3 concentration of \<30ng/ml and frank vitamin D deficiency is defined as a 25-(OH)D3 concentration of \<20ng/ml. There appears to be a growing disconnect between the observational studies and the randomized clinical trials of vitamin D supplementation in PCOS women with insulin resistance and glucose intolerance. Observational studies keep showing a fairly consistent relationship between low concentration levels of vitamin D and insulin resistance or glucose intolerance, while almost all randomized trials, including a meta-analysis of vitamin D supplementation on women suffering from PCOS shows minimal, if any, benefit in terms of correcting insulin resistance or increasing insulin sensitivity indexes or an improvement in glucose metabolism. The results published indicated that the change was not significant and did not show any difference in insulin resistance which is the core patho-physiology of this syndrome.

Vitamin D deficiency (VDD) is common in women with and without PCOS and may be associated with metabolic and endocrine disorders in PCOS. However, the phenotypic manifestation of PCOS is associated with various degrees of gonadotropic and/or metabolic abnormalities and there has been much debate as to whether it represents a single disorder or several that can only be determined by the interaction of multiple genetic and environmental factors. Previously conducted prospective observational studies that investigated the temporal relationship between VDD and metabolic disturbances (resistance to the action of insulin and glucose intolerance) in PCOS are lacking. If VDD were causally related to PCOS and the subsequent development of metabolic dysfunction in PCOS, then further prospective observational studies with repeated VDD assessment and better characterization of PCOS disease severity at enrollment are needed to clarify whether VDD is a co-determinant of metabolic dysregulations in PCOS compared to Non-PCOS women (controls).

Study design:

A prospective observational study which will be conducted in the outpatient clinics of Ain Shams University Women's Hospital after being approved by the local ethical committee.

Sample size justification:

For sample size determination, the investigators used the following formula: N= 2 x K x \[SD/μ1-μ2\]2 where N equals the number of patients per arm and K is constant (K=7.9) setting the type-1 error α at 0.5 and the power β at 80%. Results from a previous study calculated the mean (standard deviation (SD)) of vitamin Din the PCOS group(μ1)is 15.45 ± 7.88 ng/ml and in the control group(μ2) 12.83 ± 5.76ng/ml. Anticipating a 10% drop out rate, we calculated that a sample size of 83 subjects in each group, with a total of 166 subjects is enough to detect a significant difference, if any existed.

Objectives:

1. To measure plasma concentrations of vitamin D, fasting glucose, fasting Insulin, androgen levels, FSH and LH levels in all participants diagnosed with PCOS and healthy participants.
2. To clarify whether VDD is a co-determinant of metabolic dysregulations particularly insulin resistance and glucose metabolism in PCOS when compared to healthy women (controls).
3. To develop a better assessment of the PCOS severity and factors involved.

Methodology:

All of the recruited subjects will undergo:

* Written consent.
* Complete history with particular emphasis on menstrual, sexual, gynecological, medical as (Irregular cycles, oligomenorrhea, polymenorrhea, secondary amenorrhea, dysmenorrhea primary or secondary infertility, cancer, thyroid disease, galactorrhea, hirsutism, pelvic pain...etc), previous pelvic surgeries, induction of ovulation, vaginal infection, abnormal Pap smears, life style habits such as alcohol and smoking.
* Physical examination including general examination, Anthropometric measurements like weight (in kg), height (in meters), Body Mass Index (BMI), waist to hip ratio (WHR), Waist circumference (midway between the lowest rib margin and iliac crest) and hip circumference (over the widest part of the gluteal region). Signs of androgen excess, thyroid toxicity, and galactorrhea will be examined. Patients will undergo gynecological ultrasound in the follicular phase and to assess the ovarian size and morphology. Local examination to exclude uterine abnormalities, cervical tenderness, masses, vaginal infections and discharge.
* Diagnostic tests: Overnight fasting venous blood samples will be withdrawn between the 2nd and 3rd day of menstruation, and withdrawal bleeding following progesterone therapy for 5 days in amenorheic women, centrifuged and frozen to -80 C until analyzed for the assessment of vitamin D levels, Androgen levels, plasma Glucose and plasma Insulin, FSH and LH analogues.

All collected data will be tabulated and statistically analyzed.

Statistical analysis:

Descriptive statistics for measured variables will be expressed as range, mean and standard deviation (for metric data); range, median and interquartile range (for discrete data); and number and proportions (for categorical data).

Demographic data, primary and secondary outcomes of all women will be compared using t-test (for quantitative parametric measures), Mann-Whitney's U-test (for quantitative non-parametric measures) and chi-squared for Fisher's Exact tests (for categorical measures). Pearson's correlation coefficient (for metric variables) and Spearman's correlation coefficient (for rank variables) will be used to estimate association between variables. Microsoft Excel and SPSS for Windows will be used for data presentation and statistical analysis.

Ethical considerations:

The clinical research study will be conducted in accordance with the above mentioned design, safety and reporting of cases matching the relevant policies, requirements, and regulations of the Ethical Committee of the Department of Obstetrics and Gynecology - Faculty of Medicine, Ain Shams University Women's Hospital.

Consent procedure:

The investigator will make certain that an appropriate informed consent process is in place to ensure that potential research subjects, or their authorized representatives, are fully informed about the nature and objectives of the clinical study, the benefits of study participation and their rights as research subjects. The investigator will obtain a written, signed informed consent of each subject, or the subject's authorized representative, prior to performing any study-specific procedures on the subject. The investigator will retain the original signed informed consent form.

Subject confidentiality:

All evaluation forms, reports and other records that leave the site will not include unique personal data to maintain subject confidentiality.

Overnight fasting venous blood samples will be withdrawn between the 2nd and 3rd day of menstruation, and withdrawal bleeding following progesterone therapy for 5 days in amenorheic women, centrifuged and frozen to -80 C until analyzed for the assessment of vitamin D levels, Androgen levels, plasma Glucose and plasma Insulin, FSH and LH analogues.

Is There Association Between Vitamin D Levels And Insulin Resistance In Polycystic Ovary Syndrome?

Is There An Association Between Vitamin D Levels And Insulin Resistance In Polycystic Ovary Syndrome?

A validated measure of Insulin sensitivity based on fasting Insulin (uIU/mL) and Glucose (mg/dL).

A validated measure of Insulin sensitivity based on fasting Insulin (uIU/mL) and Glucose (mg/dl)

Ain Shams Maternity Hospital

Infertility

Antineoplastic Agents

Anticoagulants

Reproductive Control Agents

Gastrointestinal Agents

Other Dietary Supplements

Metformin

Letrozole

Citric Acid

Sodium Citrate

Clomiphene

Enclomiphene

Zuclomiphene

Lactitol

Aromatase Inhibitors

Estrogens

Estrogen Antagonists

Estrogen Receptor Antagonists

Hormones

Hormone Antagonists

Selective Estrogen Receptor Modulators

Estrogen Receptor Modulators

Citrate

Letrozole tablets (Femara; Novartis Pharma, Switzerland) 2.5 mg letrozole daily from day 3 of the menses for 5 days

.Drug: metformin (Cidophage®; CID,Cairo, Egypt) metformin 1500 daily for 3 months

* Drug: CC (Clomid®; Global Napi Pharmaceuticals, Cairo, Egypt) 100 mg CC for 5 days starting from day 3 of menstruation

•Drug: Letrozole tablets (Femara; Novartis Pharma, Switzerland) 2.5 mg letrozole daily from day 3 of the menses for 5 days

•Drug: CC (Clomid®; Global Napi Pharmaceuticals, Cairo, Egypt) 100 mg CC for 5 days starting from day 3 of menstruation

•Drug: metformin HCl (Cidophage®; CID,Cairo, Egypt) metformin HCl 1500 daily for 3 months

Tarek al Hussaini, prof

Safowt Abd El Rady, Prof

Mohamad S Abd Allah, Ass prof

The purpose of this study is to compare and determine the efficacy of letrozole administration to that of combined metformin and Clomiphene in infertile women with polycystic ovary syndrome (PCOS) not treated before with any ovulation induction agent

The study will be in 200 patient diagnosed to have PCOS among those attending the Fertility Outpatient Clinic at the Women's Health Center, Assiut University Hospitals.

The present study was prospective randomized controlled trial conducted over a period of 3 years from 1st of January 2009 to 1st of January 2012, at the Women's Health Center, Assiut University hospital, Assiut, Egypt, after approval was received from the Ethics Committee of faculty of medicine , Assiut University. Women referred to the infertility clinic in women's health center were screened for PCO using Rotterdam consensus criteria for the diagnosis of PCOS. The patients who were newly diagnosed as PCO and not treated previously were invited to participate in our study. Written informed consent was obtained from each participant after an information sheet had been provided. The patients had the right to refuse participation in the study or to withdraw at any time without being denied their full regular clinical care. All personal information and medical data were confidential and were not made available to third parties. All participants met the Rotterdam consensus criteria for the diagnosis of PCOS. At admission, a thorough medical history was taken and all women underwent physical examination, which included anthropometric measurements and after spontaneous menstruation or progestin induced withdrawal bleeding, basal endocrine evaluation on day 3 of the cycle included measurement of the serum concentrations of luteinizing hormone (LH), follicle-stimulating hormone (FSH),thyroid stimulating hormone(TSH ) and prolactin. Then vaginal sonographic examination were done to measure endometrial thickness and exclude cases endometrial pathology or baseline ovarian cysts.

The participants were randomized to receive letrozole or clomiphene citrate plus metformin. Randomization was performed using a computer-generated random numbers table, and allocation concealment was achieved using serially numbered opaque envelopes that were only opened once the interventions were assigned.

In the letrozole group, the ovaries were stimulated using 2.5mg/day letrozole (Femara; Novartis Pharma, Basel, Switzerland) for 5 days,in the form of one tablet( 2.5 mg) per day for 5 days from day 3 to day 7 of the menstrual cycle and if ovulation has occurred with no pregnancy continue on the same dose for another 2 consecutive cycles ,but if no ovulation increase the dose to 2 tablets per day(5 mg) for another 2 consecutive cycles in the same manner .

The patients in the second group will take metformin (Cidophage tablets,500 mg per tablet; CID, ARE, in an oral dose of 1,500 mg/d) 500mg three times daily for 3 months Plus clomid(50-mg tablets twice daily; Global Napi Pharmaceuticals, Cairo, Egypt , Arab Republic of Egypt) In the form of 50 mg twice daily (100mg /day) for 5 days from day 3 to day 7 of menstrual cycle and to be repeated for 3 consecutive cycles in the same manner if no pregnancy occur.

In both groups, endometrial thickness and mean follicular diameter were assessed by the same investigator using transvaginal ultrasound on days 2 ,10, 12, and 14 of the menstrual cycle, and 10 000 IU of human chorionic gonadotropin (hCG) (Pregnyl; Organon, Oss, The Netherlands) were injected intramuscularly if there was at least 1 leading follicle measuring 18 mm or more in diameter and endometrial thickness detected at that time(endometrial thickness was determined at the greatest diameter perpendicular to the midsagittal plane in the fundal region, including both layers of the endometrium). All participants were advised to have intercourse 24-36 hours after the hCG injection. Two days after being given Human chorionic gonadotropin, the patients were assessed for signs of ovulation (disappearance of preovulatory follicle, fluid in the cul-de-sac, and/or corpus luteum formation). Pregnancy will be diagnosed when positive pregnancy test in urine done or a gestational sac was detected on transvaginal ultrasound examination 1week after the missed period or serum β-hCG concentration 14 days after HCG injection if menses had not occurred. A biochemical pregnancy was considered when the serum β-hCG concentration was 50 mIU/mL or more in the absence of menstruation. All study medication were stopped when there was positive pregnancy test.Pregnant patients then will be followed up until an ultrasound could document the viability of pregnancy. A clinical pregnancy was defined as the presence of a gestational sac with a beating fetal heart on transvaginal ultrasound. A spontaneous abortion was defined as the spontaneous loss of a pregnancy before the end of the 20th week.

Letrozole or Combined Clomiphene Citrate Metformin as a First Line Treatment in Women With Polycystic Ovarian Syndrome

Letrozole Versus Clomiphene Citrate Plus Metformin in the First Treatment of Infertility in Patients With Polycystic Ovarian Syndrome

Principally the ovulation rate as well as the number of growing and mature follicles and endometrial thickness (mm).

The occurrence of pregnancy and miscarriage

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Effects of Simvastatin on Biochemical Parameters and Outcome of IVF-ICSI in Pcos Patients	NCT00575601	Polycystic Ovar...	SIMVASTATIN	20 Years - 40 Years	Tehran University of Medical Sciences
Effects of HICT and Intermittent Fasting on PCOS	NCT06302166	Polycystic Ovar... PCO	High Intensity ... Intermittent Fa... Combination of ...	18 Years - 35 Years	Riphah International University
Is There Association Between Vitamin D Levels And Insulin Resistance In Polycystic Ovary Syndrome?	NCT02803476	Polycystic Ovar... Insulin Resista... Vitamin D Defic...		20 Years - 35 Years	Ain Shams Maternity Hospital
Effects of Simvastatin on Biochemical Parameters and Outcome of IVF-ICSI in Pcos Patients	NCT00575601	Polycystic Ovar...	SIMVASTATIN	20 Years - 40 Years	Tehran University of Medical Sciences
Letrozole or Combined Clomiphene Citrate Metformin as a First Line Treatment in Women With Polycystic Ovarian Syndrome	NCT01679574	Polycystic Ovar...	Letrozole Clomiphene Metformin	18 Years - 35 Years	Assiut University
Letrozole or Combined Clomiphene Citrate Metformin as a First Line Treatment in Women With Polycystic Ovarian Syndrome	NCT01679574	Polycystic Ovar...	Letrozole Clomiphene Metformin	18 Years - 35 Years	Assiut University
Effects of Simvastatin on Biochemical Parameters and Outcome of IVF-ICSI in Pcos Patients	NCT00575601	Polycystic Ovar...	SIMVASTATIN	20 Years - 40 Years	Tehran University of Medical Sciences

Spots Global Cancer Trial Database for pco

Every month we try and update this database with for pco cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for pco

Every month we try and update this database with for pco cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for pco cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.