Protocol summary

Study aim
The purpose of this study is to determin the effect of a lifestyle modification program on sexual function of infertile women with polycystic ovary syndrome
Design
Clinical trial with control group, with parallel groups, without the possibility of blinding, randomized, on 144 patients. Randomization has used randomized permutation blocks with random block sizes of 4, 6 and 8 (using a table instead of random permutations)
Settings and conduct
Patients visiting Imam Khomeini Hospital Infertility Center will be visited by a physician.After reviewing the biographical history, the physical examination results of hormonal and ultrasound tests of people based on Rotterdam criteria and the doctor's diagnosis، Based on the inclusion criteria, they will enter the study and will be randomly divided into two test groups (Lifestyle Reform Program) and Control Group (Receiving Metformin)
Participants/Inclusion and exclusion criteria
Inclusion criteria :willingness to participate in research by obtaining written consent ؛Women with polycystic ovary syndrome based on Rotterdam criteria ؛Age interval between 20 and 45 years ؛Higher body mass index and equal to 24/9 ؛Infertility due to ovulation disorder exclusion criteria: Use of a special diet ؛Prohibition of physical activities ؛Chronic or severe or debilitating physical diseases or known mental illnesses
Intervention groups
Intervention group: Obtaining a lifestyle modification program in two categories: diet and physical activity, as well as other recommendations, in accordance with the lifestyle modification questionnaire Control group: Receiving metformin tablets 500 mg twice daily
Main outcome variables
sexual function

General information

Reason for update
Acronym
Polycystic Ovary Syndrome (PCOS)
IRCT registration information
IRCT registration number: IRCT20240207060925N1
Registration date: 2024-06-08, 1403/03/19
Registration timing: retrospective

Last update: 2024-06-08, 1403/03/19
Update count: 0
Registration date
2024-06-08, 1403/03/19
Registrant information
Name
Bahare Dehghan Hesampour
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 61 3373 8538
Email address
dehghanhesampour.b@ajums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-04-12, 1403/01/24
Expected recruitment end date
2024-05-13, 1403/02/24
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of lifestyle modification program on sexual function of infertile women with Polycystic Ovary Syndrome (PCOS)
Public title
The effect of lifestyle on Polycystic Ovary Syndrome
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
willingness to participate in research by obtaining written consent Women with polycystic ovary syndrome based on Rotterdam criteria Age interval between 20 and 45 years Higher body mass index and 24/9 Infertility due to ovulation disorder primary infertility
Exclusion criteria:
Use of a special diet Prohibition of physical activities Chronic or severe or debilitating physical diseases or known mental illnesses hyperprolactinemia, thyroid disorders, congenital hyperadrenalism or other endocrine disorders The addiction of the individual and the spouse to drug secondary infertility
Age
From 20 years old to 45 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 144
Randomization (investigator's opinion)
Randomized
Randomization description
The method of assigning intervention to individuals will be randomized by the method of permutation blocks.In this study, patients will be divided into two groups according to the randomization method of permutation blocks.Based on the method of permutation blocks and also based on the sample size, a number of blocks with a size of 4, 6 and 8 are considered for randomization of samples in two groups.Then, Random Allocation 1.0 software is used to create random blocks. Based on the software output and based on the size of each block with size 4 ، 6 and 8 a number from 1 to 8 which represents the block number will be randomly given to each block, and each member of the sample will be assigned a number. It is noteworthy that a random number generator is used to generate a list of random numbers corresponding to the unique numbers assigned to each member and finally each member according to the number It is randomly assigned to him and random numbers in each block will enter each of the two study groups. A randomized list will be prepared by the expert.The intervention used in this research is randomized by an individual outside the study who does not know the research objectives and according to the corresponding codes in the closed envelopes، each group will be assigned.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Factorial
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Jundi Shapour Ahvaz University of Medical Sciences
Street address
Ahvaz Jundishapur University of Medical Sciences, Esfand Estreet, Golestan highway, Ahvaz
City
Ahvaz
Province
Khouzestan
Postal code
00986135715794
Approval date
2024-03-04, 1402/12/14
Ethics committee reference number
IR.AJUMS.REC.1402.688

Health conditions studied

1

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

Primary outcomes

1

Description
Sexual function score in FSFI questionnaire
Timepoint
Before the study begins (zero week) and immediately after the intervention (12 weeks) and 4 weeks after the intervention ends (16 weeks)
Method of measurement
FSFI questionnaire

Secondary outcomes

1

Description
Changes in weight
Timepoint
Before the study begins (zero week) and immediately after the intervention (12 weeks) and 4 weeks after the intervention ends (16 )
Method of measurement
Weight measurement instruments

2

Description
changes in body mass index
Timepoint
Before the study begins (zero week) and immediately after the intervention (12 weeks) and 4 weeks after the intervention ends (16 )
Method of measurement
Weight and height measurement instruments

Intervention groups

1

Description
Intervention group:The intervention group is given a lifestyle modification program for12 weeks that includes recommendations for healthy eating, including the elimination of simple carbohydrates (remove sugar and sugar intake)،And..... consuming fresh vegetables, whole grains and fibres, aerobic activity on a daily basis for half an hour of alcohol and tobacco use, as well as recommendations to reduce stress and promote healthy behaviors such as sleep.
Category
Lifestyle

2

Description
Control group: The control group is also given metformin 500 mg oral 2 times a day for 12 weeks.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Imam Khomeini Hospital
Full name of responsible person
Mina Iravani
Street address
Imam Khomeini Medical Center, Azadegan avenue , Ahvaz
City
AHVAZ
Province
Khouzestan
Postal code
6135715794
Phone
+98 61 3222 2114
Email
dehghanhesamour.b@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Mehrnoush Zaker Kish
Street address
Ahvaz Jundishapur University of Medical Sciences, Esfand Street, Golestsn highway, Ahvaz
City
Ahvaz
Province
Khouzestan
Postal code
6135715794
Phone
+98 61 3311 0000
Email
aduaum@ajums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Ahvaz 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
Ahvaz University of Medical Sciences
Full name of responsible person
Mina Iravani
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Midwifery
Street address
Ahvaz Jundishapur University of Medical Sciences, Esfand Estreet, Golestan highway, Ahvaz
City
Ahvaz
Province
Khouzestan
Postal code
6135715794
Phone
+98 61 3311 0000
Email
minairavani2004@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Mina Iravani
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Midwifery
Street address
Ahvaz Jundishapur University of Medical Sciences, Esfand Estreet, Golestan highway, Ahvaz
City
Ahvaz
Province
Khouzestan
Postal code
6135715794
Phone
+98 61 3311 0000
Email
minairavani2004@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Mina Iravani
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Midwifery
Street address
Ahvaz Jundishapur University of Medical Sciences, Esfand Estreet, Golestan highway, Ahvaz
City
Ahvaz
Province
Khouzestan
Postal code
6135715794
Phone
+98 61 3311 0000
Email
minairavani2004@gmail.com

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
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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