Protocol summary
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Study aim
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Determining the effect of yoga on improving the clinical symptoms of polycystic ovary syndrome in infertile women
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Design
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The study of a clinical trial with unblinded parallel groups including the intervention group that does yoga and the control group that does not receive any intervention. includes 128 samples in two groups of 64 people who are divided by random block method.
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Settings and conduct
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This is a randomized clinical trial study on 128 infertile women with pcos referred to Fatemieh Hospital in Hamadan in 2023-2024. In addition to routine treatment, the intervention group will do yoga for 3 months and the control group will receive routine treatment. Before the intervention and after 3 months, ovarian ultrasound and clinical evaluations will be done for both groups
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Participants/Inclusion and exclusion criteria
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Inclusion criteria: Women with polycystic ovary syndrome between the ages of 18 and 35
Exclusion criteria: suffering from any debilitating chronic disease, suffering from hyperprolactinemia, thyroid abnormalities, non-classical adrenal hyperplasia, drug addiction and smoking history, practicing yoga
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Intervention groups
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The intervention group includes people practicing yoga.
The control group includes people who do not receive any specific treatment.
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Main outcome variables
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Polycystic ovary syndrome
General information
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Reason for update
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20220317054318N5
Registration date:
2023-08-13, 1402/05/22
Registration timing:
registered_while_recruiting
Last update:
2026-08-25, 1405/06/03
Update count:
2
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Registration date
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2023-08-13, 1402/05/22
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Expected recruitment start date
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2023-07-23, 1402/05/01
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Expected recruitment end date
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2024-07-22, 1403/05/01
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Actual recruitment start date
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empty
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Actual recruitment end date
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empty
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Trial completion date
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empty
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Scientific title
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Evaluate the effect of yoga on improving the clinical symptoms of polycystic ovary syndrome in infertile women
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Public title
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The effect of yoga on polycystic ovaries
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Purpose
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Treatment
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Inclusion/Exclusion criteria
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Inclusion criteria:
Women with polycystic ovary syndrome
Age between 18 and 35 years
Exclusion criteria:
Having any chronic debilitating disease, hyperprolactinemia, thyroid abnormalities, non-classical adrenal hyperplasia
Addiction and history of smoking
Doing yoga
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Age
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From 18 years old to 35 years old
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Gender
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Female
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Phase
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N/A
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Groups that have been masked
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No information
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Sample size
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Target sample size:
128
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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The selection of those eligible to enter the study is done in an easy and accessible way, then the people with the conditions to enter the study are randomly divided into two intervention and control groups. In this way, 18 sheets of paper, with the letter A written on 9 sheets and the letter B written on the other 9 sheets, were placed in the desk drawer and each person was given a sheet, according to which the letter A or B was written, they belonged to the intervention or control group, respectively. It takes until 18 leaves are finished and it is returned to the drawer to divide all the samples.
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Blinding (investigator's opinion)
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Not blinded
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Blinding description
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Placebo
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Not used
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Assignment
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Parallel
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Other design features
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Ethics committees
1
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Ethics committee
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Approval date
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2023-07-01, 1402/04/10
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Ethics committee reference number
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IR.UMSHA.REC.1402.277
Health conditions studied
1
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Description of health condition studied
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Polycystic ovary syndrome
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ICD-10 code
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E28.2
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ICD-10 code description
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Polycystic ovarian syndrome
Primary outcomes
1
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Description
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Polycystic ovary syndrome
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Timepoint
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Investigating the symptoms of polycystic ovary syndrome at the beginning of the study and then 2 months after yoga exercises
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Method of measurement
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Through the quality of life questionnaire for patients with polycystic ovary syndrome and two-dimensional ovarian ultrasound
Intervention groups
1
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Description
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Intervention group: People with polycystic ovary syndrome who in addition to routine treatment practice yoga for 12 weeks (once a week in-person training in the gym under the supervision of a trainer and 5 times a week doing ovarian yoga exercises at home using previous face-to-face training and training package for 1 hour, which will include 45 minutes of asana exercises and then 15 minutes of deep relaxation). In order to follow up the exercise at home, the sample people will be contacted weekly and the exercise checklist will be completed by the research people. Pcos quality of life questionnaire is completed with two-dimensional ovarian sonography ) and tests ( testesteron, dehydroepiandrosterone sulfate and 17-hydroxyprogesterone level) before and 3 It will be checked the month after the study.
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Category
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Treatment - Other
2
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Description
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Control group: People with polycystic ovary syndrome who receive routine treatment including folic acid supplementation.
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Category
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N/A
1
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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No
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Title of funding source
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Hamedan University of Medical Sciences
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Proportion provided by this source
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100
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Public or private sector
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Public
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Academic
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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Undecided - It is not yet known if there will be a plan to make this available
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Study Protocol
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Undecided - It is not yet known if there will be a plan to make this available
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Statistical Analysis Plan
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Undecided - It is not yet known if there will be a plan to make this available
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Informed Consent Form
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Undecided - It is not yet known if there will be a plan to make this available
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Clinical Study Report
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Undecided - It is not yet known if there will be a plan to make this available
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Analytic Code
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Undecided - It is not yet known if there will be a plan to make this available
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Data Dictionary
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Undecided - It is not yet known if there will be a plan to make this available