FertilOMed Diet: FertilOMed Diet (Experimental): Participants will follow the FertilOMed Diet, which is based on the standard Mediterranean Diet guidelines, with required consumption of specific foods and adherence to recommended food group portions. Dietary adherence will be monitored through food diaries and follow-up consultations.
MedDiet: Mediterranean Diet (Active Comparator): Participants will follow a standard Mediterranean Diet for the duration of the study. Dietary adherence will be monitored through food diaries and follow-up consultations.
Study summary
The goal of this clinical trial is to evaluate whether different dietary models can improve clinical, metabolic, hormonal, anthropometric, and quality-of-life parameters in women with polycystic ovary syndrome (PCOS).
The main questions it aims to answer are:
* Do the Mediterranean Diet and the FertilOMed Diet (Fertility-Optimized Mediterranean Diet) lead to significant improvements in these parameters compared to the control group?
* Does the FertilOMed Diet lead to greater improvements compared to the standard Mediterranean Diet? Study Description: This randomized controlled intervention study will be conducted between November 2025 and March 2026 at the Samsun Training and Research Hospital, Department of Obstetrics and Gynecology, Women's Health Outpatient Clinics. Necessary institutional permissions have been obtained for conducting the study at these sites.
Participants: Women diagnosed with PCOS who meet the inclusion criteria and volunteer to participate will be included in the study.
Interventions:
Participants will be randomly assigned to one of the following groups:
* Mediterranean Diet group
* FertilOMed Diet group (Fertility-Optimized Mediterranean Diet)
* Control group (standard dietary recommendations) Researchers will compare these groups to determine whether the dietary interventions improve clinical, biochemical, and symptomatic outcomes in women with PCOS.
Eligibility
Sex
FEMALE
Min age
20 Years
Max age
45 Years
Healthy volunteers
Accepted
Inclusion Criteria:
* Being diagnosed with PCOS according to the Rotterdam Criteria, between the ages of 20 and 45,
* Having a Body Mass Index (BMI) of 18.50-35.00 kg/m2,
* Not having used antibiotics and/or probiotics in the last month,
* Signing a voluntary consent form.
Exclusion Criteria:
* Being younger than 20 years old or older than 45 years old with PCOS diagnosis,
* Having a BMI of ≤18.50 kg/m2 and ≥35.00 kg/m2,
* Being pregnant or breastfeeding,
* Using alcohol,
* Having used antibiotics and/or probiotics in the last month,
* Having had bariatric surgery,
* Having type 1 diabetes, type 2 diabetes, Cushing's syndrome, hypothyroidism, androgen tumors, active cancer, or a gastrointestinal system or malabsorption disease,
* Having used hormonal contraceptives or insulin sensitivity-enhancing medications within 3 months before the study start,
* Having used antioxidant supplements such as vitamin C within 1 month before the study start,
* Having a Mediterranean Diet Adherence Score (MEDAS) of ≥10,
* Those who did not give their consent after reading the informed consent form.
Primary outcome measure(s)
Changes in Hormonal Profile — Participants follow the dietrary intervention and are assessed at baseline and at the end of the 12-week intervention. The primary outcome measure of this study is to evaluate holistic changes in the reproductive-metabolic profile of individuals with PCOS following the dietary intervention. This composite outcome includes coordinated changes in hormonal balance (e.g., FSH, LH, Estradiol, Progesterone, 17-Hydroxyprogesterone, DHEAS, T4, TSH, Prolactin, SHBG, AMH, Total Testosterone, and FAI). All parameters will be measured at baseline and after the 12-week dietary intervention, and changes will be analyzed to determine the overall impact of the applied dietary model. These parameters will be obtained by scanning the participants' routine results from their file information.
Changes in Metabolic Profile — Participants follow the dietrary intervention and are assessed at baseline and at the end of the 12-week intervention. The primary outcome measure of this study is to evaluate holistic changes in the reproductive-metabolic profile of individuals with PCOS following the dietary intervention. This composite outcome includes coordinated changes in metabolic profile (e.g., , AST, ALT, Hemogram, D Vitamini, B12 Vitamini, SHBG, HbA1c, AMH, Total Testosteron, Glukoz, İnsülin, HOMA IR, HDL, LDL, Trigliserit, Total Kolesterol). All parameters will be measured at baseline and after the 12-week dietary intervention, and changes will be analyzed to determine the overall impact of the applied dietary model. These parameters will be obtained by scanning the participants' routine results from their file information.
Changes in Oxidative Stress — Participants follow the dietrary intervention and are assessed at baseline and at the end of the 12-week intervention. The primary outcome measure of this study is to evaluate holistic changes in the reproductive-metabolic profile of individuals with PCOS following the dietary intervention. This composite outcome includes coordinated changes in hormonal balance (e.g.,TAC, Vit C, SOD, Catalase, Glutathione Peroxidase (GPx) and Malondialdehyde (MDA)). All parameters will be measured at baseline and after the 12-week dietary intervention, and changes will be analyzed to determine the overall impact of the applied dietary model. These parameters will be determined by performing validated commercial ELISA kits in accordance with the manufacturer's instructions and evaluating with a microplate reader.
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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