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IRCT20171007036615N17 IRCT 2026-09-28 Tabriz University of Medical Sciences The effect of Microbiome-Focused Nutritional Education with the Trans-Theoretical Model on Anxiety and retrieved oocyte count in women undergoing IVF The effect of Microbiome-Focused Nutritional Education with the Trans-Theoretical Model on Anxiety and retrieved oocyte count in women undergoing IVF: A Randomized Controlled Trial 2026-10-07 anticipated 60 Recruiting https://irct.ir/trial/93545 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Education/Guidance, Randomization description: The study will include 60 participants (calculated based on two primary variables: mean anxiety score and mean number of retrieved oocytes), who will be allocated to either the intervention or control group by a person not involved in sampling, using stratified random block allocation based on infertility type (primary or secondary) and treatment cycle (first or second), employing the Random Allocation Software (RAS) with blocks of 4 and 6 at a 1:1 ratio. The allocation will be written on paper and placed in sequentially numbered opaque envelopes (allocation concealment). The envelopes will be opened in the order of participants' entry into the study, Blinding description: The outcome assessor and data analyst in this study will be blinded to the allocation of participants to the groups. The initial outcome assessment before randomization will be conducted by the principal investigator (who administers the intervention). However, the outcome evaluation and data analysis will be performed by other individuals not involved in participant allocation, sampling, or intervention administration. N/A infertility. Intervention 1: Intervention group: For the intervention group, during a coordinated in-person session held in groups of four to six participants, dietary education, an explanation of the intervention method, and an educational pamphlet will be provided. The content of the educational program (pamphlet, podcast, images containing educational messages, and short educational videos) is designed in relation to microbiome-based nutrition with the aim of improving gut and reproductive tract microbiome health, and includes topics such as appropriate nutrition for strengthening the microbiome (consumption of fiber, fermented foods, and probiotics), reducing the intake of processed foods and simple sugars, and avoiding the excessive use of antibiotics. The content validity of the educational materials will be reviewed by the research team and ten faculty members from the Departments of Midwifery, Obstetrics and Gynecology, and Nutrition. Ultimately, the content will be delivered as messages in a virtual channel and made available to participants in the intervention group twice a week. To enhance understanding of the importance of nutrition in treatment outcomes and adherence to the recommended diet, the messages will contain simple and comprehensible information to address informational and practical barriers. In addition, short daily messages will be sent to invite participants to take practical action and to remind them to perform the recommended actions. The intervention will be delivered for 8 weeks before the initiation of treatment, twice a week. On the first occasion, immediately after uploading the materials, participants will be informed about the upload and encouraged to study the content. Participants will be requested to provide feedback by sending a private message with a 'like' symbol to the researcher once they have reviewed the materials, and if they have any questions about the materials posted in the channel, they will receive the necessary guidance. In case of no feedback from the participant until 24 hours after uploading the materials, a second reminder SMS will be sent. In case of no feedback again until 48 hours, a phone call will be made to the participant. Intervention 2: Control group: The control group will not receive any intervention. Yes - There is a plan to make this available What will be shared: Part of the data related to the study outcomes will be available for sharing. When: Access period starts 6 months after the results are published. To whom: The data will be available only to researchers working in academic and scientific institutions. Conditions: De-identified data available for meta-analysis or replication studies, with approval from the principal investigator. Where to obtain: By sending an email to the email address of Dr. Esmat Mehrabi: b.mehrabi62@gmail.com How to obtain: Emails sent by applicants to Dr. Esmat Mehrabi's email address (b.mehrabi62@gmail.com) will be responded to within one week. Comments:
public Aylar Abdzadeh
School of Nursing & Midwifery, South Shariati St.,Tabriz
Tabriz Iran (Islamic Republic of) 5138947977 +98 41 3740 8683 aylar.abdzadeh11@gmail.com Tabriz University of Medical Sciences scientific Dr. Esmat Mehrabi
School of Nursing and Midwifery, South Shariati St., Tabriz
Tabriz Iran (Islamic Republic of) 5138947977 +98 41 3479 0364 b.mehrabi62@gmail.com Tabriz University of Medical Sciences Iran (Islamic Republic of) 1. Married women aged 15 to 49 years2. Undergoing infertility treatment (IVF/ICSI) for the first or second time3. No concurrent use of probiotic or prebiotic supplements within the past month4. State anxiety score between 32 and 535. Precontemplation and contemplation stages of behaviour change6. Possession of a smartphone7. Minimum literacy level of lower secondary education8. Verbal and auditory communication ability and ability to use mobile applications 15 years 49 years Male 1. History of underlying chronic diseases such as diabetes, hypertension, or heart disease based on the patient's medical record2. Antibiotic use at the time of sampling and within the preceding month3. Adherence to a specific dietary regimen4. Psychiatric illness or use of psychiatric medications based on patient self-report5. Current participation in related educational programs N97 Female infertility Lifestyle N/A Intervention group: For the intervention group, during a coordinated in-person session held in groups of four to six participants, dietary education, an explanation of the intervention method, and an educational pamphlet will be provided. The content of the educational program (pamphlet, podcast, images containing educational messages, and short educational videos) is designed in relation to microbiome-based nutrition with the aim of improving gut and reproductive tract microbiome health, and includes topics such as appropriate nutrition for strengthening the microbiome (consumption of fiber, fermented foods, and probiotics), reducing the intake of processed foods and simple sugars, and avoiding the excessive use of antibiotics. The content validity of the educational materials will be reviewed by the research team and ten faculty members from the Departments of Midwifery, Obstetrics and Gynecology, and Nutrition. Ultimately, the content will be delivered as messages in a virtual channel and made available to participants in the intervention group twice a week. To enhance understanding of the importance of nutrition in treatment outcomes and adherence to the recommended diet, the messages will contain simple and comprehensible information to address informational and practical barriers. In addition, short daily messages will be sent to invite participants to take practical action and to remind them to perform the recommended actions. The intervention will be delivered for 8 weeks before the initiation of treatment, twice a week. On the first occasion, immediately after uploading the materials, participants will be informed about the upload and encouraged to study the content. Participants will be requested to provide feedback by sending a private message with a 'like' symbol to the researcher once they have reviewed the materials, and if they have any questions about the materials posted in the channel, they will receive the necessary guidance. In case of no feedback from the participant until 24 hours after uploading the materials, a second reminder SMS will be sent. In case of no feedback again until 48 hours, a phone call will be made to the participant. Control group: The control group will not receive any intervention. Anxiety score. Timepoint: Before the intervention and immediately after the completion of the intervention. Method of measurement: Spielberger State Anxiety Inventory (Form 1). Number of retrieved oocytes. Timepoint: Two weeks after the completion of the intervention and the initiation of treatment. Method of measurement: Laboratory record / Embryology data registration checklist. Retrieved oocyte quality. Timepoint: Two weeks after the completion of the intervention and the initiation of treatment. Method of measurement: Laboratory record / Embryology data registration checklist. Frequency of pregnancy. Timepoint: four weeks after the completion of the intervention and the initiation of treatment. Method of measurement: Patient record. Embryos obtained. Timepoint: four weeks after the completion of the intervention and the initiation of treatment. Method of measurement: Laboratory record / Embryology data registration checklist. Quality of obtained embryos. Timepoint: four weeks after the completion of the intervention and the initiation of treatment. Method of measurement: Laboratory record / Embryology data registration checklist. Frequency of continuation of pregnancy up to the first trimester. Timepoint: Four months after the completion of the intervention and the initiation of treatment. Method of measurement: Patient record. Women's depression score. Timepoint: Before the intervention and immediately after the completion of the intervention. Method of measurement: BDI-II questionnaire. Frequency of stages of behavioral change for dietary pattern. Timepoint: Before the intervention and immediately after the completion of the intervention. Method of measurement: Behavioral Change Stages Checklist. Fertilized oocytes. Timepoint: four weeks after the completion of the intervention and the initiation of treatment. Method of measurement: Laboratory record / Embryology data registration checklist. Tabriz University of Medical Sciences Approved 2026-09-23 Ethics Committee of Tabriz University of Medical Sciences Central Building, Tabriz University of Medical Sciences, Golgasht St., Tabriz Tabriz East Azarbaijan Iran (Islamic Republic of)