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Polycystic Ovary Syndrome clinical trials

View clinical trials related to Polycystic Ovary Syndrome.

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NCT ID: NCT06418347 Recruiting - Clinical trials for Polycystic Ovary Syndrome

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

Start date: April 1, 2024
Phase: Phase 3
Study type: Interventional

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.

NCT ID: NCT06417099 Recruiting - Clinical trials for Polycystic Ovary Syndrome

Efficacy of Dihydroartemisinin for Treating PCOS

Start date: May 2024
Phase: Phase 2
Study type: Interventional

The primary research hypothesis of this study is that dihydroartemisinin is effective in restoration of regular menstrual cycles of PCOS subjects who meet at least two of three Rotterdam Criteria. Secondary research hypotheses include: dihydroartemisinin is also effective in reducing androgen, total immature follicles, and anti-Mullerian hormone.

NCT ID: NCT06401850 Recruiting - Quality of Life Clinical Trials

Polycystic Ovary Syndrome and Education

Start date: October 26, 2023
Phase: N/A
Study type: Interventional

Aim: This research is being designed to determine the effect of Polycystic Ovary Syndrome (PCOS) education given to women on their quality of life. In this context, the aim of the project is; The aim is to determine the impact of the education given to women with PCOS on the quality of life of the training given to women with the disease, such as psychosocial and emotional status, fertility, sexual function, obesity and menstrual irregularity, and hair growth. Method: Within the scope of this research, quantitative research method is used as the research method. In addition, it is planned as a randomized controlled quasi-experimental, which is one of the quantitative research methods. In calculating the sample size, type 1 error, research power and effect size parameters are determined before the research begins. Studies generally need to have at least 80% power. In order to find a significant difference, it is calculated that there should be at least 30 students in each group at 80% power and 95% confidence level. Considering the possible risks, it is planned to include 70 women in total in 2 groups (study and control), with 35 women in each group. All individuals who want to respond to the survey are included in the sample. The process of finding a subject continues until the desired size is reached. In addition, during the data collection process, participants were asked; They are asked whether they are diagnosed with PCOS and those who answer "yes" are included in the sample. Within the scope of the research, the voluntariness of the participants is essential and both written and verbal consents are obtained from each participant through an informed consent form. "Personal Information Form" and "Polycystic Ovary Syndrome Quality of Life-50 Scale" created by the researchers were used as data collection tools.

NCT ID: NCT06339567 Recruiting - Clinical trials for Polycystic Ovary Syndrome

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

Hemo-PCOS
Start date: February 8, 2024
Phase: N/A
Study type: Interventional

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).

NCT ID: NCT06325969 Recruiting - Metformin Clinical Trials

PCOS Patients Immune Status Evaluation

Start date: March 16, 2024
Phase:
Study type: Observational

In this study, the investigators will include PCOS patients and healthy women who meet the trial criteria from the clinical research centers of 3 hospitals, introduce the content of this study to participants, and invite participants to participate. Flow cytometry was used to detect the immune function of peripheral blood samples of PCOS patients, to clarify the immune function characteristics of PCOS patients, and to try to establish an evaluation method of the immune function of PCOS patients.

NCT ID: NCT06325956 Recruiting - Clinical trials for Polycystic Ovary Syndrome

PCOS Immune Function Predicts Metformin Efficacy

Start date: March 16, 2024
Phase: N/A
Study type: Interventional

In this study, the investigators will include PCOS patients who meet the trial criteria, introduce participants to the content of this study, and invite participants to participate. The immune function of peripheral blood samples of PCOS patients was detected by flow cytometry. Participants were further treated with metformin for 6 months and followed up after the intervention. The objective of this study was to investigate immune markers related to the efficacy of metformin in PCOS patients and to predict the efficacy of metformin in PCOS patients using immune function.

NCT ID: NCT06306417 Recruiting - Clinical trials for Polycystic Ovary Syndrome (PCOS)

A Randomized Controlled Trial of Acupuncture for Insulin Resistance in Patients With Polycystic Ovary Syndrome

Start date: September 28, 2023
Phase: N/A
Study type: Interventional

To determine the efficacy and safety of 2 different treatment modalities: 1) acupuncture plus lifestyle management (treatment group), 2) placebo plus lifestyle management (control group) in the treatment of insulin resistance in PCOS patients.

NCT ID: NCT06303219 Recruiting - Clinical trials for Polycystic Ovarian Syndrome

Effects of Traditional Moderate Intensity Training and High Intensity Interval Training in Polycystic Ovarian Syndrome

Start date: November 23, 2023
Phase: N/A
Study type: Interventional

To determine the comparative effects of traditional moderate intensity training and high intensity interval training on Anxiety, fatigue and Quality of Life in females with polycystic ovarian syndrome

NCT ID: NCT06302166 Recruiting - Clinical trials for Polycystic Ovary Syndrome

Effects of HICT and Intermittent Fasting on PCOS

Start date: March 15, 2024
Phase: N/A
Study type: Interventional

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.

NCT ID: NCT06300593 Recruiting - Clinical trials for Polycystic Ovary Syndrome

Activity of Chronic Inflammation in PCOS

Start date: January 15, 2024
Phase:
Study type: Observational

Chronic inflammation in polycystic ovary syndrome (PCOS) may be the result of dysregulation of cytokine production (due to insulin resistance, excess visceral fat and hyperandrogenemia), i.e., overproduction of pro-inflammatory factors (e.g. TNF, IL-1, IL-6) in relation to anti-inflammatory ones (IL-10). This condition may be an important link between obesity and insulin resistance, which is crucial in the etiopathogenesis of the syndrome. However, it is not known whether it results from the tendency to accumulate adipose tissue or is a feature of the syndrome itself. There is no data indicating the relationship between chronic inflammation and the severity of metabolic disorders and the value of ovarian reserve in women with various PCOS phenotypes.