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
To determine the effect of microbiome-based nutrition education using the trans-theoretical model on anxiety and the number of retrieved oocytes in women undergoing IVF treatment
Design
The study will include 60 participants, 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 and treatment cycle, employing the RAS with blocks of 4 and 6 at a 1:1 ratio.
Settings and conduct
Sampling will be conducted among women undergoing IVF or ICSI treatment who are referred to the infertility clinic of Alzahra Hospital in Tabriz. After reviewing the main inclusion criteria, the researcher will provide an explanation regarding the objectives and procedures of the study.
Participants/Inclusion and exclusion criteria
Women undergoing IVF or ICSI treatment, aged 15 to 49 years, in the precontemplation and contemplation stages of dietary behavior change, with an anxiety score between 32 and 53; those who have used antibiotics at the time of sampling or within the preceding month will be excluded.
Intervention groups
For the intervention group, a coordinated face-to-face session will be held in groups of 4 to 6 participants, during which nutritional education, an explanation of the intervention method, and an educational pamphlet will be provided. The educational content will be delivered as messages via a virtual channel to participants in the intervention group twice a week. The intervention will be delivered for 8 weeks prior to the initiation of treatment. The control group will receive no intervention.
Main outcome variables
Comparison of the mean anxiety score; and the mean number of retrieved oocytes
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20171007036615N17
Registration date:2026-09-28, 1405/07/06
Registration timing:prospective
Last update:2026-09-28, 1405/07/06
Update count:0
Registration date
2026-09-28, 1405/07/06
Registrant information
Name
عصمت مهرابی
Name of organization / entity
دانشگاه علوم پزشکی تبریز
Country
Iran (Islamic Republic of)
Phone
+98 41 3477 0649
Email address
mehrabie@tbzmed.ac.ir
Recruitment status
recruiting
Funding source
Expected recruitment start date
2026-10-07, 1405/07/15
Expected recruitment end date
2027-01-20, 1405/10/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
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
Public title
The effect of Microbiome-Focused Nutritional Education with the Trans-Theoretical Model on Anxiety and retrieved oocyte count in women undergoing IVF
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
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
Exclusion criteria:
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
Age
From 15 years old to 49 years old
Gender
Male
Phase
N/A
Groups that have been masked
Outcome assessor
Data analyser
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
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 (investigator's opinion)
Single blinded
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.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Tabriz University of Medical Sciences
Street address
Central Building, Tabriz University of Medical Sciences, Golgasht St., Tabriz
City
Tabriz
Province
East Azarbaijan
Postal code
5138947-977
Approval date
2026-09-23, 1405/07/01
Ethics committee reference number
IR.TBZMED.REC.1405.431
Health conditions studied
1
Description of health condition studied
infertility
ICD-10 code
N97
ICD-10 code description
Female infertility
Primary outcomes
1
Description
Anxiety score
Timepoint
Before the intervention and immediately after the completion of the intervention
Method of measurement
Spielberger State Anxiety Inventory (Form 1)
2
Description
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
Secondary outcomes
1
Description
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
2
Description
Frequency of pregnancy
Timepoint
four weeks after the completion of the intervention and the initiation of treatment
Method of measurement
Patient record
3
Description
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
4
Description
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
5
Description
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
6
Description
Women's depression score
Timepoint
Before the intervention and immediately after the completion of the intervention
Method of measurement
BDI-II questionnaire
7
Description
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
8
Description
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
Intervention groups
1
Description
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.
Category
Lifestyle
2
Description
Control group: The control group will not receive any intervention.
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Infertility Clinic of Alzahra Hospital, Tabriz
Full name of responsible person
Aylar Abdzadeh
Street address
South Artesh Street, Baghshomal Intersection, Tabriz
City
Tabriz
Province
East Azarbaijan
Postal code
5138663134
Phone
+98 41 3553 9161
Fax
+98 41 3556 6449
Email
alzahrahospital@tbzmed.ac.ir
Web page address
https://alzahrahosp.tbzmed.ac.ir/
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Dr. Khosro Adibkia
Street address
Central Building, Tabriz University of Medical Sciences, Golgasht St., Tabriz
City
Tabriz
Province
East Azarbaijan
Postal code
5138947977
Phone
+98 41 3335 7310
Fax
+98 41 3334 4280
Email
research-vice@tbzmed.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Tabriz University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Aylar Abdzadeh
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
School of Nursing & Midwifery, South Shariati St.,Tabriz
City
Tabriz
Province
East Azarbaijan
Postal code
5138947977
Phone
+98 41 3740 8683
Email
aylar.abdzadeh11@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Dr. Esmat Mehrabi
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Midwifery
Street address
School of Nursing and Midwifery, South Shariati St., Tabriz
City
Tabriz
Province
East Azarbaijan
Postal code
5138947977
Phone
+98 41 3479 0364
Email
b.mehrabi62@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Dr. Esmat Mehrabi
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Midwifery
Street address
School of Nursing and Midwifery, South Shariati St., Tabriz
City
Tabriz
Province
East Azarbaijan
Postal code
5138947977
Phone
+98 41 3479 0364
Email
b.mehrabi62@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
Title and more details about the data/document
Part of the data related to the study outcomes will be available for sharing.
When the data will become available and for how long
Access period starts 6 months after the results are published.
To whom data/document is available
The data will be available only to researchers working in academic and scientific institutions.
Under which criteria data/document could be used
De-identified data available for meta-analysis or replication studies, with approval from the principal investigator.
From where data/document is obtainable
By sending an email to the email address of Dr. Esmat Mehrabi: b.mehrabi62@gmail.com
What processes are involved for a request to access data/document
Emails sent by applicants to Dr. Esmat Mehrabi's email address (b.mehrabi62@gmail.com) will be responded to within one week.