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IRCT20130903014551N13 IRCT 2023-08-12 Esfahan University of Medical Sciences The effect of adherence to profertility diet on assisted reproduction outcomes The effect of profertility dietary intervention on assisted reproduction outcomes: A randomized controlled trial 2023-10-23 anticipated 360 Complete https://irct.ir/trial/71704 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Other design features: In the present study the intervention will be done based on the components of profertility diet. One of these components is dietary supplementation by high dose folate, vitamin B12, vitamin D and omega-3 fatty acids, Randomization description: Allocation of infertile couples to either intervention or control groups will be done by permuted blocked randomization with the help of 4 blocking. The process will be conducted using a valid random number generation website. (http://www.sealedenvelope.com/simple-randomiser/v1/lists) The randomized allocation and assignment of participants into intervention groups will be performed by a trained person who is not involved in the trial, Blinding description: The participants will be blinded to the intervention. N/A Condition 1: Female Infertility. Condition 2: Male infertility. Intervention 1: Intervention group: the intervention in women will be as follows; supplementation with folate 1 mg/day, vitamin B12 500 mcg/day, vitamin D 1000 IU/day and omega-3 fatty acids 1000 mg/day- At least 4 servings/day from low-pesticide residue fruit and vegetables- maximum 1 serving/day of high-pesticide residue fruit and vegetables- education to consume whole grain cereals instead of simple or refined carbohydrates- at least 2.5 servings/day of dairy- at least 1 serving/day soy or soy products. The intervention in men will be as follows: to decrease the consumption of soy or soy products, caffeinated beverages, processed meat and saturated and trans fatty acids- to decrease the consumption of high-pesticide residue fruit and vegetables (max 1 serving/day)- to increase the consumption of seafoods. For each participant, energy requirements will be estimated by Harris-Benedict formula, based on a isocaloric diet. A dietitian will organize a weekly dietary plan for each participant with 15 to 20% of calorie comes from proteins, 25 to 30% from fats and 55 to 60% from carbohydrates. Intervention 2: Control group: women in the control group will be provided by dietary recommendations based on healthy eating plate. They also will consume 400 mcg/day folate. Men in the control group will be provided by dietary recommendations based on Healthy eating plate as well. For each participant, energy requirements will be estimated by Harris-Benedict formula, based on a isocaloric diet. A dietitian will organize a weekly dietary plan for each participant with 15 to 20% of calorie comes from proteins, 25 to 30% from fats and 55 to 60% from carbohydrates. Yes - There is a plan to make this available What will be shared: Data relating to primary and secondary outcomes is available upon reasonable request When: Data will be available after publication of the results To whom: Investigators from academic or scientific institutes Conditions: Research projects from academic institutes Where to obtain: Principal investigators of the research project including Mohammad Hossein Rouhani and Rahele Ziaei How to obtain: Contact by sending request to principal investigators Comments:
public Rahele Ziaei
School of Nutrition and Food Science, Isfahan University of Medical Sciences, Isfahan, Iran
Isfahan Iran (Islamic Republic of) 8174673461 +98 913 305 1052 r.ziaei92@gmail.com Esfahan University of Medical Sciences scientific Mohammad Hossein Rouhani
School of Nutrition and Food Science, Isfahan University of Medical Sciences, Isfahan, Iran
Isfahan Iran (Islamic Republic of) 8174673461 +98 913 327 6157 sm_rouhani@nutr.mui.ac.ir Esfahan University of Medical Sciences Iran (Islamic Republic of) Age between 18 to 42 years BMI between 20 to 30 kg/m2 Consent to participate 18 years 42 years Both Current or previous (within three months) drug use including oral contraceptive pills, hormone therapy, insulin sensitizers or antidiabetics, weight reducing compounds and dietary supplements History of chronic and endocrine disorders including diabetes and impaired glucose tolerance History of having more than 2 unsuccessful ART cycles Adherence to specific diets or exercise programs Tobacco or alcohol consumption Infertility due to tubal or uteri disorders Consumption of more than two servings of fatty fish per week N97 N46 Female infertility Male infertility Treatment - Other Treatment - Other Intervention group: the intervention in women will be as follows; supplementation with folate 1 mg/day, vitamin B12 500 mcg/day, vitamin D 1000 IU/day and omega-3 fatty acids 1000 mg/day- At least 4 servings/day from low-pesticide residue fruit and vegetables- maximum 1 serving/day of high-pesticide residue fruit and vegetables- education to consume whole grain cereals instead of simple or refined carbohydrates- at least 2.5 servings/day of dairy- at least 1 serving/day soy or soy products. The intervention in men will be as follows: to decrease the consumption of soy or soy products, caffeinated beverages, processed meat and saturated and trans fatty acids- to decrease the consumption of high-pesticide residue fruit and vegetables (max 1 serving/day)- to increase the consumption of seafoods. For each participant, energy requirements will be estimated by Harris-Benedict formula, based on a isocaloric diet. A dietitian will organize a weekly dietary plan for each participant with 15 to 20% of calorie comes from proteins, 25 to 30% from fats and 55 to 60% from carbohydrates. Control group: women in the control group will be provided by dietary recommendations based on healthy eating plate. They also will consume 400 mcg/day folate. Men in the control group will be provided by dietary recommendations based on Healthy eating plate as well. For each participant, energy requirements will be estimated by Harris-Benedict formula, based on a isocaloric diet. A dietitian will organize a weekly dietary plan for each participant with 15 to 20% of calorie comes from proteins, 25 to 30% from fats and 55 to 60% from carbohydrates. Clinical pregnancy rate. Timepoint: At the end of the assisted reproductive technology cycle. Method of measurement: The presence of an intrauterine pregnancy confirmed by ultrasound at 6 weeks’ gestation. Endometrial thickness and antral follicle count. Timepoint: At the end of the intervention and within ART cycle. Method of measurement: Transvaginal sonography. The number of retrieved, metaphase 2 and normal morphology oocytes. Timepoint: At the end of the intervention and within ART cycle. Method of measurement: By embryologist. Fertilization rate. Timepoint: At the end of the intervention and within ART cycle. Method of measurement: The ratio of oocytes that reached the two-pronucleate (2PN) stage to the number of metaphase II (MII) oocytes. Embryo formation rate. Timepoint: At the end of the intervention and within ART cycle. Method of measurement: The ratio of embryos to oocytes with two pronuclei. Embryo grade based on Scott criteria. Timepoint: At the end of the intervention and within ART cycle. Method of measurement: By embryologist. The number of transferred embryos. Timepoint: At the end of the intervention and within ART cycle. Method of measurement: By infertility specialist. Biochemical pregnancy rate. Timepoint: At the end of the ART cycle. Method of measurement: َA serum b-human chorionic gonadotropin level >6 mIU/mL, typically measured 17 days (range,15 to 20 days) after egg retrieval. Sperm quality parameters. Timepoint: At baseline and at the end of the trial. Method of measurement: By infertility specialist. Serum folic acid level. Timepoint: At baseline and at the end of the trial. Method of measurement: Electrochemiluminescence immunoassay method. Serum B12 level. Timepoint: At baseline and at the end of the trial. Method of measurement: Electrochemiluminescence immunoassay method. Serum vitamin D level. Timepoint: At baseline and at the end of the trial. Method of measurement: کروماتوگرافی مایع با کارایی بالا-طیف‌سنجی جرمی. Esfahan University of Medical Sciences Approved 2023-07-17 Ethics committee of Isfahan University of Medical Sciences-Research Ethics Committee of the Alzahra Isfahan University of Medical Sciences, Hezar-Jerib st., Isfahan, Iran Isfahan Isfehan Iran (Islamic Republic of)