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The effect of high-intensity interval training and nanocurcumin consumption of microRNAs(miRNA) 29a-5P, 93 and Anti Mullerian Hormone(AMH) in infertile women with polycystic ovary syndrome

Protocol summary

Study aim
The goal: whether high-intensity interval training(HIIT) and nanoCurcumin supplementation in infertile women with PCOS causes changes in MicroRNA (miRNA) 29a-5p, 93,Anti Mullerian Hormone (AMH) and Body Mass Index (BMI)?
Design
A controlled, single-blind, randomized, phase 3 clinical trial with factorial design, on 40 patients. How to randomize: 40 beads numbered from 1 to 4 are placed in a box. Then one of the beads is randomly took out, and people are classified into different groups based on the number.
Settings and conduct
Study place: in Roya infertility center, Qom province; The study population: infertile women with polycystic ovary syndrome; Type of blinding is single blind; The method of blinding will be in a way that the patients will be unaware of their treatment group, and the training-supplement group will receive nanocurcumin and the training-placebo group will receive capsules containing flour.
Participants/Inclusion and exclusion criteria
Inclusion criteria: infertile women, with PCOS, age between 20-38 years (fertility age). Exclusion criteria: cardiovascular and respiratory disease, use of hormonal drugs
Intervention groups
Intervention group 1: high-intensity interval training (HIIT)+ nanocurcumin; Intervention group 2: HIIT + placebo. Intervention group 3: Nano curcumin; Control group: placebo. Training protocol: High-intensity interval training starts with 80% HRmax and ends with 95% HRmax intensity in the last weeks. These exercises are 3 days a week. During the period, participants in intervention group 1 and 3 will take 80 mg capsules of nanocurcumin with a daily dose, and the control group will also use a placebo.
Main outcome variables
MicroRNA (miRNA) 29a-5P; MicroRNA 93; Anti Mullerian Hormone(AMH); Body Mass Index (BMI)

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20231217060434N1
Registration date: 2024-01-26, 1402/11/06
Registration timing: prospective

Last update: 2024-01-26, 1402/11/06
Update count: 0
Registration date
2024-01-26, 1402/11/06
Registrant information
Name
Fateme Talashan
Name of organization / entity
The university of Tehran
Country
Iran (Islamic Republic of)
Phone
+98 25 3289 6680
Email address
fateme.talashan@ut.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-02-20, 1402/12/01
Expected recruitment end date
2024-05-20, 1403/02/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of high-intensity interval training and nanocurcumin consumption of microRNAs(miRNA) 29a-5P, 93 and Anti Mullerian Hormone(AMH) in infertile women with polycystic ovary syndrome
Public title
The effects of exercise and supplement on infertile women with PCOS
Purpose
Basic scienece
Inclusion/Exclusion criteria
Inclusion criteria:
Infertile women Women with PCOS Age between 20 and 38 years (fertility age)
Exclusion criteria:
Cardiovascular disease Respiratory disease Using hormonal drugs
Age
From 20 years old to 38 years old
Gender
Female
Phase
3
Groups that have been masked
  • Participant
Sample size
Target sample size: 40
Randomization (investigator's opinion)
Randomized
Randomization description
Forty beads are placed in a box numbered from 1 to 4. After accepting each patient and obtaining informed consent, one of the beads is randomly took out of the box, and people are classified into different groups based on the number on the beads, so that numbers 1 belong to the group of HIIT, numbers 2: nanoCurcumin supplement, Numbers 3: HIIT+nanocurcumin, numbers 4: placebo. In general, this will be done on 40 patients.
Blinding (investigator's opinion)
Single blinded
Blinding description
The method of blinding will be in a way that the patients will be unaware of their treatment group, and the training-supplement group will receive nanocurcumin and the training-placebo group will receive capsules containing flour.
Placebo
Used
Assignment
Factorial
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Faculty of Physical Education and Sport Sciences - University of Tehran
Street address
Faculty of Physical Education and Sport Sciences, between 15th and 16th street, North Kargar street, Tehran
City
Tehran
Province
Tehran
Postal code
37 - 88351730
Approval date
2023-11-26, 1402/09/05
Ethics committee reference number
IR.UT.SPORT.REC.1402.080

Health conditions studied

1

Description of health condition studied
Polycystic ovary syndrome
ICD-10 code
E28.2
ICD-10 code description
Polycystic ovarian syndrome

2

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

Primary outcomes

1

Description
microRNA 29a-5P
Timepoint
before the start of the intervention and 3 months after the intervention at the end of the work.
Method of measurement
blood test

2

Description
Anti Mullerian Hormone
Timepoint
before the start of the intervention and 3 months after the intervention at the end of the work.
Method of measurement
blood test

3

Description
microRNA 93
Timepoint
before the start of the intervention and 3 months after the intervention at the end of the work.
Method of measurement
blood test

Secondary outcomes

1

Description
Body Mass Index
Timepoint
before the start of the intervention and 3 months after the intervention at the end of the work.
Method of measurement
BMI formula

Intervention groups

1

Description
Intervention group 1: exercise-supplement. Subjects of the exercise-supplement group take one 80 mg capsule of nanocurcumin with a daily dose during the period. High-intensity interval training starts with 80% HRmax and ends with 95% HRmax in the last weeks. These exercises are held 3 days a week and each training session lasts for 30 minutes (5 minutes of warming up, 15 minutes of training, 10 minutes of cooling down) and includes 4 hours. Each set consists of 4 movements, each of which is performed for 30 seconds with high intensity and takes 15 seconds.
Category
Other

2

Description
Intervention group2: Exercise-placebo group. They receive capsules containing flour. Because the exercise + supplement group and the exercise group will both exercise together in the hall, the exercise group will also be given a placebo so that the two groups of patients do not notice the difference between people. High-intensity interval training starts with 80% HRmax and ends with 95% HRmax in the last weeks. These exercises are held 3 days a week and each training session lasts for 30 minutes (5 minutes of warming up, 15 minutes of training, 10 minutes of cooling down) and includes 4 hours. Each set consists of 4 movements, each of which is performed for 30 seconds with high intensity and takes 15 seconds.
Category
Other

3

Description
Intervention group 3: supplementary group. Subjects in the supplement group will take 80 mg nanocurcumin capsules at a daily dose during the period.
Category
Treatment - Drugs

4

Description
Control group: Also, the control group will use a placebo (containing flour, but if not used, the people in the control group will be prone to celiac disease).
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Rouya Infertility Center
Full name of responsible person
Leila naserpor
Street address
Rouya center for infertility treatment, Shabnam street, Shahid Karimi Blvd., Qom
City
Qom
Province
Ghoum
Postal code
3716986466
Phone
+98 25 3210 4000
Email
rooyaivfacecrqom@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Faculty of Physical Education and Sport Sciences - University of Tehran
Full name of responsible person
Mohammad Reza Kordi
Street address
Faculty of Physical Education and Sport Sciences, between 15th and 16th street, North Kargar street, Tehran
City
Tehran
Province
Tehran
Postal code
37 - 88351730
Phone
+98 21 8835 1730
Email
infosport@ut.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Faculty of Physical Education and Sport Sciences - University of Tehran
Proportion provided by this source
50
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

2

Sponsor
Name of organization / entity
Iranian academic center for education culture and research
Full name of responsible person
Leila Naserpor
Street address
Rouya center for infertility treatment, Shabnam street, Shahid Karimi Blvd., Qom
City
Qom
Province
Ghoum
Postal code
3716986466
Phone
+98 25 3210 4000
Email
rooyaivfacecrqom@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Rouya Infertility Center
Proportion provided by this source
50
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
The University of Qom
Full name of responsible person
Amir hossain Delshad
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Exercise physiology
Street address
After Quds settlement, Al-Ghadir Boulevard, Qom
City
Qom
Province
Ghoum
Postal code
3716146611
Phone
+98 25 3210 3693
Fax
Email
ah_delshad@yahoo.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
The University of Tehran
Full name of responsible person
Mohammad reza kordi
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Exercise physiology
Street address
Faculty of Physical Education and Sport Sciences, between 15th and 16th street, North Kargar street, Tehran
City
Tehran
Province
Ghoum
Postal code
37 - 88351730
Phone
+98 21 8802 1527
Fax
Email
mrkordi@ut.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
The University of Tehran
Full name of responsible person
Fateme Talashan
Position
PhD student
Latest degree
Master
Other areas of specialty/work
Exercise physiology
Street address
No.60, Jomhoori tower, Shahroz street, Jomhoori street.
City
Qom
Province
Ghoum
Postal code
3716819964
Phone
+98 25 3289 6680
Fax
Email
fateme.talashan@ut.ac.ir

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
Due to participants' demands and the condition of this matter to participate in the project and to protect their privacy, the data will be preserved, but in case of reasonable request from the relevant organizations or people, the information of the project will be 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
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
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