Investigation of the Effects of DASH and Standard Diets With and Without Curcumin Supplementation on Gene Expression of Interleukin-1 Alpha , 5 Alpha – Reductase, Serum Concentration of Testosterone and Glycemic Indices in Infertile Women With Polycystic Ovary Syndrome Candidate for In Vitro Fertilization (IVF)

Investigate the effects of DASH diet and Curcumin on expression of Interleukin 1 Alpha , 5 Alpha reductase and androgenic and glycemic profile, in women with polycystic ovary syndrome (PCOS)

A randomized, double-blind, placebo-controlled trial, with a 2*2 factorial design; 96 patients will be randomly assigned to four groups using a Stratified Permuted Block Randomization, in equal block sizes of 4; by Package ‘blockrand’ in R software, 4.0.2 version.

Study will be conducted at Yazd Reproductive Sciences Institute; COVID-19 screening,dietary assessing, blood sampling, analysis of body composition and anthropometric indices will be performed; mRNA expression levels, androgenic and glycemic profile will be evaluated by using Real-Time PCR and ELISA methods, respectively. After 12 weeks, all of the above steps will be repeated. Curcumin and placebo will be provided in similar bottles with different letters (A, B; labeled by someone not related to the study); participants and researchers will not be aware of bottles content.

Inclusion criteria: Infertile women with PCOS, aged 18–40 years, candidate for In Vitro Fertilization; Major exclusion criteria: having metabolic abnormalities, hypertension, cancer and mental illness; taking anti-diabetic, androgenic and contraceptives drugs.

All participants will receive Curcumin or placebo (500 mg twice daily) plus individual diet (DASH or standard); 1) Curcumin plus DASH diet; 2) Curcumin plus standard diet; 3) Placebo plus DASH diet; 4) Placebo plus standard diet.

Expression values of interleukin-1 alpha and 5 alpha – reductase genes; Serum levels of testosterone and 5α-dihydrotestosterone; FBS, insulin and homeostasis model assessment of insulin resistance.

Actual sample size, actual recruitment start date and actual recruitment end date were added.

The participants will be assigned to four groups according to the method of Stratified Permuted Block Randomization based on BMI (BMI:18.5-25 and BMI ≥25), in equal block sizes of 4; Therefore, participants will have an equal chance for being in each group. A random allocation list will be created by Package ‘blockrand’ in R software, 4.0.2 version. The intervention groups will be randomly allocated into 4 groups: Group 1: 500 mg Curcumin twice daily and DASH diet, Group 2: 500 mg Curcumin twice daily and standard diet, Group 3: 500 mg Placebo twice daily and DASH diet, Group 4: 500 mg Placebo twice daily and standard diet.

Supplements and placebos capsules will be provided in the same appearance (in terms of color and shape) and packed in similar bottles. The bottles will be labeled with different marks (A and B), by someone not related to the study. Each bottle contains 64 capsules (for one month use and two days of grace period). Participants and researchers will not be aware of bottles content. As well as intervention groups will be assigned to receive two healthy dietary patterns (DASH or standard diet). These diets will be designed in the form of an individual diet containing 18 % protein, 52 % carbohydrates, and 30 % total fat. Overall, DASH and standard patterns will be designed using similar foods and recipes, but in different amounts, to achieve the specific characteristics of each diet.The amount of sodium prescribed for each diet will be the same. Two Midwifery experts will check the baseline measurements, a COVID-19 screening, inclusion and exclusion criteria. They will give consecutive numbers to eligible participant and refer them to a nutritionist who is not involved in this study. Participants will receive their specific diet through face-to-face individual counseling. 12- Week menu plans (7-day cycle menu with 21 meals) at eleven energy levels (1200, 1300, 1400, 1500, 1600, 1700, 1800, 1900, 2000, 2100 and 2200 kcal) for both dietary patterns will be constructed and analyzed. Both diets will be planned by the study dietitian and reviewed by the chief Investigator. These will be considered as the basis for participants' individual diets. Then the specific diet of each person will be calculated. Nutritionist IV software will be used for calculations. In our opinion, this study is double-blind, because all the researchers and final analysts will remain conceal from the allocation and will not be able to distinguish between groups. Participants will only aware of the type of diet but will not know the content of placebo or curcumin supplement.

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