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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

Protocol summary

Study aim
Determining the effect of sleep hygiene education and diet based on Iranian traditional medicine texts on the results of in vitro fertilization (IVF/ICSI) of infertile women.
Design
Randomized controlled clinical trial with 2 control and intervention groups on 124 patients, and the random allocation process will be done with Random Allocation 2.0 software.
Settings and conduct
Imam Khomeini Hospital (RA), Sari City, Infertility Treatment Center, the samples were entered into the study as available and divided into two control and intervention groups by random allocation. In this study, there is a possibility of blinding at the level of outcome evaluation and analysis.
Participants/Inclusion and exclusion criteria
Inclusion criteria: age 18 to 45 years, the satisfaction of couples (self and spouse) to participate in the study, primary or secondary infertile women (with a history of previous pregnancy) with ovarian problems or infertility with unexplained causes, exclusion criteria To study: suffering from infertility due to anatomical causes, suffering from infertility due to male causes, suffering from uterine myoma and hydrosalpinx, smoking, drinking alcoholic beverages, suffering from diabetes, suffering from sleep disorders, using complementary and herbal treatments for infertility during 3 months of intervention implementation, surrogacy
Intervention groups
The intervention group followed the educational package of sleep hygiene and diet based on Iranian traditional medicine texts for up to 3 months, and the control group did not receive any intervention.
Main outcome variables
The primary outcomes include the number of eggs, the number of mature eggs, the number of embryos, the quality of embryos, the rate of conception, the rate of implantation, and the secondary outcomes of studying the rate of spontaneous pregnancy, chemical pregnancy and clinical pregnancy.

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20231004059612N1
Registration date: 2023-10-28, 1402/08/06
Registration timing: prospective

Last update: 2023-10-28, 1402/08/06
Update count: 0
Registration date
2023-10-28, 1402/08/06
Registrant information
Name
fazeleh fazlollahpourrokni
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 11 3373 4002
Email address
fa.fazlollahpour@umz.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-12-22, 1402/10/01
Expected recruitment end date
2024-03-10, 1402/12/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
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
Public title
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
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Primary or secondary infertile women with ovarian problems or unexplained causes
Exclusion criteria:
Infertility with anatomical or male causes with sleep disorders and diabetes
Age
From 18 years old to 45 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 124
Randomization (investigator's opinion)
Randomized
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.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of mazandaran University of Medical Sciences
Street address
ساری- میدان معلم- ساختمان شماره2 دانشگاه علوم پزشکی و خدمات بهداشتی درمانی
City
sari
Province
Mazandaran
Postal code
4848157945
Approval date
2023-10-02, 1402/07/10
Ethics committee reference number
IR.MAZUMS.REC.1402.388

Health conditions studied

1

Description of health condition studied
Primary or secondary infertility of women with ovarian or unexplained causes
ICD-10 code
N97.9
ICD-10 code description
Female infertility, unspecified

Primary outcomes

1

Description
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

2

Description
the number of mature eggs
Timepoint
After the intervention
Method of measurement
The number of mature eggs is measured with a stereomicroscope.

3

Description
the number of embryos
Timepoint
After the intervention
Method of measurement
Morphological examination of the fetus

4

Description
the quality of embryos
Timepoint
After the intervention
Method of measurement
Morphological examination of the fetus

5

Description
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

6

Description
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

Secondary outcomes

1

Description
the spontaneous pregnancy rate
Timepoint
after the end of the intervention
Method of measurement
Spontaneous pregnancy rate based on ultrasound

2

Description
chemical pregnancy
Timepoint
after the end of the intervention
Method of measurement
based on quantitative beta test (B-HCG)

3

Description
clinical pregnancy
Timepoint
after the intervention
Method of measurement
Based on ultrasound

Intervention groups

1

Description
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
Category
Lifestyle

2

Description
Control group: Control group: will not receive any intervention before in vitro fertilization.
Category
Lifestyle

Recruitment centers

1

Recruitment center
Name of recruitment center
مرکز درمان ناباروری بیمارستان امام خمینی (ره) شهرستان ساری
Full name of responsible person
سیده صدیقه یوسفی
Street address
Razi St
City
sari
Province
Mazandaran
Postal code
4848157945
Phone
+98 11 3336 1700
Email
dr.fazeleh@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
seyede sedighe yousofi
Street address
Imam Square, Joibar Three Roads, the beginning of Valiasr Highway, Mazandaran University of Medical Sciences
City
sari
Province
Mazandaran
Postal code
Imam Square, Joibar
Phone
+98 11 3304 4000
Email
ravabetomoomi@mazums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mazandaran 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
Mazandaran University of Medical Sciences
Full name of responsible person
seyede sedighe yousofi
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Traditional Medicine
Street address
Tabaristan St, Khazar Square
City
sari
Province
Mazandaran
Postal code
4848157945
Phone
+98 11 3324 3117
Email
dr_ssyosefi@yahoo.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
seyede sedighe yosefi
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Traditional Medicine
Street address
Tabarestan Street, Khazar Square
City
sari
Province
Mazandaran
Postal code
4848157945
Phone
+98 11 3324 3117
Email
dr_ssyosefi@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Fazeleh Fazlollahpourrokni
Position
PhD student in persian medicine
Latest degree
Medical doctor
Other areas of specialty/work
Traditional Medicine
Street address
No6,west sarallah.,mehr Blvd.,Masoudi Town
City
Sari
Province
Mazandaran
Postal code
4848157945
Phone
+98 11 3373 4002
Fax
Email
fa.fazlollahpour@umz.ac.ir

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be 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
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Yes - There is 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, such as the information about the results, can be shared
When the data will become available and for how long
6 months after the publication of the show
To whom data/document is available
For researchers working in academic institutions
Under which criteria data/document could be used
Only researchers who need additional information of this study in their research process.
From where data/document is obtainable
In charge of the project, Dr. Seyede Siedighe Yousefi,dr_ssyosefi@yahoo.com
What processes are involved for a request to access data/document
After the email request for additional information will be answered within a week.
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