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Investigating the effect of modification of lifestyle and temperament based on Iranian traditional medicine compared to routine treatment on the results of in vitro fertilization in overweight and obese infertile women

Protocol summary

Study aim
Investigating the effect of modification of lifestyle and temperament based on Iranian traditional medicine on the results of in vitro fertilization in overweight and obese infertile women.
Design
Clinical trial with control group, with parallel groups, randomized, on 100 infertile women. For randomization, allocation sequence was used based on block randomization method with blocks of size 4.
Settings and conduct
Sampling will be done in Arash and Erfan hospitals in Tehran. The case group will receive 4 traditional medicine visits, each visit with an interval of one month (3 months in total), before embryo transfer, and the control group will receive routine care before embryo transfer.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Infertility due to diminished ovarian reverse and polycystic ovary; Body mass index greater than or equal to 25 to 34.9; Having a cold and wet temperament; Women aged 20-40 years; Primary infertility. Exclusion criteria: Infertility due to anatomical causes, male causes, endometriosis, unexplained causes; Candidates for egg donation and embryo donation; Smoking and alcohol consumption, Suffering from uncontrolled physical and chronic diseases.
Intervention groups
The intervention group will receive modification of lifestyle and temperament based on traditional Iranian medicine in 4 visits, with a time interval of one month between each two visits(3 months in total), before embryo transfer. The control group will only receive routine interventions of modern medicine before IVF.
Main outcome variables
Clinical pregnancy; the number of oocyte; number of mature oocyte; number of embryo; embryo quality; fertilization rate; implantation rate; chemical pregnancy.

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20240610062075N1
Registration date: 2024-08-07, 1403/05/17
Registration timing: prospective

Last update: 2024-08-07, 1403/05/17
Update count: 0
Registration date
2024-08-07, 1403/05/17
Registrant information
Name
Maryam Fasanghari
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 3894 4952
Email address
fasanghari.maryam@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-09-05, 1403/06/15
Expected recruitment end date
2025-03-20, 1403/12/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the effect of modification of lifestyle and temperament based on Iranian traditional medicine compared to routine treatment on the results of in vitro fertilization in overweight and obese infertile women
Public title
The effect of modification of lifestyle and temperament on the results of in vitro fertilization
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Infertility due to diminished ovarian reverse and polycystic ovary Body mass index greater than or equal to 25 to 34.9 Having a cold and wet temperament Primary infertility Women aged 20- 40 years
Exclusion criteria:
Infertility due to anatomical causes, male causes, endometriosis, unexplained causes Candidates for egg donation and embryo donation Smoking and Alcohol consumption Suffering from uncontrolled physical and chronic diseases including uncontrolled diabetes, uncontrolled blood pressure, autoimmune diseases, serious liver and kidney disease, cancers, gastrointestinal diseases that prohibit the use of hormonal drugs.
Age
From 20 years old to 40 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 100
Randomization (investigator's opinion)
Randomized
Randomization description
The allocation sequence will be generated using the block method of size 4and using the website https://www.sealedenvelope.com/.People are assigned to 2 groups based on the order of their entry into the study. Allocation sequence will be hidden in white envelopes. In this way, with the entry of each person into the study according to the person's number, the relevant envelope is opened for them and each person is assigned to the desired group. Each sequence letter is placed inside a white envelope. The envelopes are placed next to each other. To ensure that the envelopes are not moved, the envelopes are numbered.
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 Shahroud University of Medical Sciences
Street address
Shahroud University of Medical Sciences, Hafte Tir Square
City
Shahroud
Province
Semnan
Postal code
3614773955
Approval date
2022-11-02, 1401/08/11
Ethics committee reference number
IR.SHMU.REC.1401.155

Health conditions studied

1

Description of health condition studied
Infertility
ICD-10 code
N97
ICD-10 code description
Female infertility

Primary outcomes

1

Description
Clinical pregnancy
Timepoint
6 weeks after embryo transfer
Method of measurement
observation of fetal heart activity by transvaginal ultrasonography

Secondary outcomes

1

Description
Number of oocyte
Timepoint
The day of oocytes pick up
Method of measurement
Microscopic examination

2

Description
Number of mature oocyte
Timepoint
The day of oocytes pick up
Method of measurement
Examination with a microscope based on morphology

3

Description
Number of embryo
Timepoint
3rd or 5th day after IVF
Method of measurement
With the help of a microscope and based on the guidelines agreed by the embryologist

4

Description
Embryo quality
Timepoint
3rd or 5th day after IVF
Method of measurement
With the help of a microscope and based on the guidelines agreed by the embryologist

5

Description
Implantation rate
Timepoint
2 weeks after embryos transfer
Method of measurement
βhCG test

6

Description
fertilization rate
Timepoint
The day after the puncture operation
Method of measurement
Examination with a microscope based on morphology

7

Description
Chemical pregnancy
Timepoint
Two weeks after embryo transfer
Method of measurement
βhCG test

Intervention groups

1

Description
Intervention group: Lifestyle modification training, recommendations for softening and reducing food, examining and removing abdominal spasms using special abdominal massage and ovarian dry cupping, to correct and strengthen ovulation: aslagh Capsule (Tuba company) two pieces fasting in the morning and two pieces at night time to sleep (use during non-menstrual periods), syrup honey& royal gelly, one jam spoon fasting in the morning (Daya Company),Nice soda syrup (Farateb Company), one tablespoon 3 times a day, prescription of fertility diet, low carbohydrate diet with reduced consumption of red meat
Category
Treatment - Other

2

Description
Control group: Routine care and treatments before embryo transfer
Category
Treatment - Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Arash hospital
Full name of responsible person
Dr Ladan Kashani
Street address
Eastern 162th alley, Shahid Baghdarnia street, Resalat Highway, Tehranpars
City
Tehran
Province
Tehran
Postal code
1653915981
Phone
+98 21 7788 3283
Fax
+98 21 7788 3196
Email
hosp_arash@tums.ac.ir
Web page address
https://arash.tums.ac.ir

2

Recruitment center
Name of recruitment center
Erfan hospital
Full name of responsible person
Dr. Elhamosadat Mirhashemi
Street address
Shahid Riazi Bakhshayesh St. Between Shahrdari Blvd. and Sarv Intersection, Saadat Abad
City
Tehran
Province
Tehran
Postal code
1998884349
Phone
+98 21 2302 1000
Fax
+98 21 2235 6113
Email
erfan@erfanhospital.ir
Web page address
https://erfanhospital.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Shahroud University of Medical Sciences
Full name of responsible person
Dr. Behzad Garmabi
Street address
Shahroud University of Medical Sciences, Hafte Tir Square
City
Shahroud
Province
Semnan
Postal code
3614773955
Phone
+98 23 3239 1609
Email
vcr@shmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahroud 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
Shahroud University of Medical Sciences
Full name of responsible person
Maryam Fasanghari
Position
Student
Latest degree
Ph.D.
Other areas of specialty/work
Reproductive health
Street address
Shahroud University of Medical Sciences and Health Services, Hafte Tir square
City
Shahroud
Province
Semnan
Postal code
3614773955
Phone
+98 23 3239 5054
Fax
+98 23 3239 1609
Email
fasanghari.maryam@yahoo.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Shahroud University of Medical Sciences
Full name of responsible person
Dr Reza Chaman
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Epidemiology
Street address
Shahroud University of Medical Sciences and Health Services, Hafte Tir square
City
Shahroud
Province
Semnan
Postal code
3614773955
Phone
+98 23 3239 1609
Email
rezachaman@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
Shahroud University of Medical Sciences
Full name of responsible person
Maryam Fasanghari
Position
Student
Latest degree
Ph.D.
Other areas of specialty/work
Reproductive health
Street address
hahroud University of Medical Sciences and Health Services, Hafte Tir square
City
Shahroud
Province
Semnan
Postal code
3614773955
Phone
+98 23 3239 5054
Fax
+98 23 3239 1609
Email
fasanghari.maryam@yahoo.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
There is no further information.
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
No - There is not a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
Not applicable
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