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IRCT20231004059612N1 IRCT 2023-10-28 Mazandaran University of Medical Sciences The effect of sleep hygiene education and diet based on Persian traditional medicine texts on the results of in vitro fertilization (IVF/ICSI) of infertile women The effect of sleep hygiene education and diet based on Persian traditional medicine texts on the results of in vitro fertilization (IVF/ICSI) of infertile women 2023-12-22 anticipated 124 Complete https://irct.ir/trial/73060 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Blocking will be done by randomization method. The randomization unit of infertile women is classified into age groups of less than 30, 30 to 34, 35 to 39, and 40 to 45 years, stratified random allocation will be done in each of the age groups. In total, 31 blocks of 4 will be used for allocation. The random allocation process will be done with Random Allocation 2.0 software. N/A Primary or secondary infertility of women with ovarian or unexplained causes. Intervention 1: Intervention group: Intervention group: For the people of the intervention group, two face-to-face sessions will be held by an expert in traditional Iranian medicine and a researcher. Each meeting will be held for 60 minutes at the Obstetrics and Gynecology Department of Imam Khomeini Hospital (RA) in Sari, in most of 12 groups of 10 people, with an interval of one week from each other (46-48). Most of the PowerPoint content will be presented to the patients. In the first session, recommendations related to lifestyle and health improvement in the area of sleep based on Iranian traditional medicine texts, and in the second session, recommendations related to dietary compliance based on Iranian traditional medicine texts will be presented, and the content package "diet, sleep" And the 147-item standard food frequency questionnaire (Food Frequency Questionnaire) whose validity and reliability have been measured and confirmed with Spearman's correlation coefficient of 0.47-0.69 in research conducted in Iran (51-49) will be presented. Completing the food frequency questionnaire by the patients is to know the type and amount of food consumed by them during the intervention. The control group will receive the usual treatments. The duration of observing the diet and sleep package is three months (19, 31), which begins with the onset of the patient's menstrual period. Individuals will be followed up to implement diets and sleep. The researcher will follow up by phone once a week and in person once a month. At the end of the second month and after two periods of menstruation, the subjects in the study enter the IVF/ICS cycle. Two weeks after IVF, a small B-hcg test is checked to check for chemical pregnancy. If the result of the test is positive, one month later, an ultrasound will be performed by a radiologist to check the fetal heart and clinical pregnancy(52). The follow-up of patients who have a positive clinical pregnancy will be continued by the researcher until the 12th week of pregnancy. At the end of the study, IVF/ICSI success is measured in two groups. Intervention 2: Control group: Control group: will not receive any intervention before in vitro fertilization. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is The study has not yet entered the implementation phase and a specific decision has not been made regarding this matter.
public seyede sedighe yousofi
Tabaristan St, Khazar Square
sari Iran (Islamic Republic of) 4848157945 +98 11 3324 3117 dr_ssyosefi@yahoo.com Mazandaran University of Medical Sciences scientific seyede sedighe yosefi
Tabarestan Street, Khazar Square
sari Iran (Islamic Republic of) 4848157945 +98 11 3324 3117 dr_ssyosefi@yahoo.com Mazandaran University of Medical Sciences Iran (Islamic Republic of) Primary or secondary infertile women with ovarian problems or unexplained causes 18 years 45 years Both Infertility with anatomical or male causes with sleep disorders and diabetes N97.9 Female infertility, unspecified Lifestyle Lifestyle Intervention group: Intervention group: For the people of the intervention group, two face-to-face sessions will be held by an expert in traditional Iranian medicine and a researcher. Each meeting will be held for 60 minutes at the Obstetrics and Gynecology Department of Imam Khomeini Hospital (RA) in Sari, in most of 12 groups of 10 people, with an interval of one week from each other (46-48). Most of the PowerPoint content will be presented to the patients. In the first session, recommendations related to lifestyle and health improvement in the area of sleep based on Iranian traditional medicine texts, and in the second session, recommendations related to dietary compliance based on Iranian traditional medicine texts will be presented, and the content package "diet, sleep" And the 147-item standard food frequency questionnaire (Food Frequency Questionnaire) whose validity and reliability have been measured and confirmed with Spearman's correlation coefficient of 0.47-0.69 in research conducted in Iran (51-49) will be presented. Completing the food frequency questionnaire by the patients is to know the type and amount of food consumed by them during the intervention. The control group will receive the usual treatments. The duration of observing the diet and sleep package is three months (19, 31), which begins with the onset of the patient's menstrual period. Individuals will be followed up to implement diets and sleep. The researcher will follow up by phone once a week and in person once a month. At the end of the second month and after two periods of menstruation, the subjects in the study enter the IVF/ICS cycle. Two weeks after IVF, a small B-hcg test is checked to check for chemical pregnancy. If the result of the test is positive, one month later, an ultrasound will be performed by a radiologist to check the fetal heart and clinical pregnancy(52). The follow-up of patients who have a positive clinical pregnancy will be continued by the researcher until the 12th week of pregnancy. At the end of the study, IVF/ICSI success is measured in two groups Control group: Control group: will not receive any intervention before in vitro fertilization. The number of eggs. Timepoint: before the start of the intervention and after the completion of the intervention. Method of measurement: the number of eggs by ultrasound of the ovary. The number of mature eggs. Timepoint: After the intervention. Method of measurement: The number of mature eggs is measured with a stereomicroscope. The number of embryos. Timepoint: After the intervention. Method of measurement: Morphological examination of the fetus. The quality of embryos. Timepoint: After the intervention. Method of measurement: Morphological examination of the fetus. The rate of fertilization. Timepoint: after the intervention. Method of measurement: Fertilization rate is the ratio of the number of fertilized eggs to the number of mature eggs. The rate of implantation. Timepoint: after the intervention. Method of measurement: the implantation rate is defined as the number of gestational sacs seen in ultrasound divided by the total number of embryos. The spontaneous pregnancy rate. Timepoint: after the end of the intervention. Method of measurement: Spontaneous pregnancy rate based on ultrasound. Chemical pregnancy. Timepoint: after the end of the intervention. Method of measurement: based on quantitative beta test (B-HCG). Clinical pregnancy. Timepoint: after the intervention. Method of measurement: Based on ultrasound. Mazandaran University of Medical Sciences Approved 2023-10-02 Ethics committee of mazandaran University of Medical Sciences ساری- میدان معلم- ساختمان شماره2 دانشگاه علوم پزشکی و خدمات بهداشتی درمانی sari Mazandaran Iran (Islamic Republic of)