Red color represents old content. It may be empty showing addition in the new version.
Green color represents new content. It may be empty showing deletion in the new version.
Inline
Side by side
Added new contents,
deleted old contents,contents that are not changed.
New table contents
New table contents
Old table contents
Old table contents
Unchanged contents
Unchanged contents
Added new contents, contents that are not changed.
Deleted old contents, contents that are not changed.
Old table contents
Old table contents
Unchanged contents
Unchanged contents
New table contents
New table contents
Unchanged contents
Unchanged contents
Intervention groups
#1
Intervention group: People with polycystic ovary syndrome who in addition to routine treatment practice yoga for 6 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 vasculography and lipid profile tests (including ldl, hdl, trigliserid, cholesterol) and tests (amh, fsh esteradiol, testesteron, tsh, prolactin, dehydroepiandrosterone sulfate and 17-hydroxyprogesterone level) before and 3 It will be checked the month after the study.
Intervention group: People with polycystic ovary syndrome who in addition to routine treatment practice yoga for 6 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.
Intervention group: People with polycystic ovary syndrome who in addition to routine treatment practice yoga for 6 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 vasculography and lipid profile tests (including ldl, hdl, trigliserid, cholesterolsonography ) and tests (amh, fsh esteradiol, testesteron, tsh, prolactin, dehydroepiandrosterone sulfate and 17-hydroxyprogesterone level) before and 3 It will be checked the month after the study.
گروه مداخله: افراد مبتلا به سندروم تخمدان پلی کیستیک که علاوه بر درمان روتین ورزش یوگا را به مدت 6 هفته ( هفته ای یکبار آموزش حضوری در سالن تحت نظر مربی و 5 بار در هفته انجام تمرینات یوگا تخمدان در منزل با استفاده از آموزش های حضوری قبلی و بسته آموزشی به مدت 1 ساعت که شامل 45 دقیقه تمرینات آسانا و سپس 15 دقیقه آرام سازی عمیق خواهد بود)، انجام خواهند داد. جهت پیگیری انجام تمرینات در منزل با افراد نمونه در هفته تماس برقرار خواهد شد و چک لیست انجام تمرینات توسط افراد پژوهش تکمیل خواهد شد. پرسشنامه کیفیت زندگی PCOS تکمیل می گردد وسو نوگرافی دو بعدی تخمدان و آزمایشات پروفایل لیپید (شامل ldl, hdl,trigliserid ,cholestrol) و آزمایشات (amh، fsh، esteradiol testesteron ،tsh، پرولاکتین، دهیدرواپی آندروسترون سولفات و17- سطح هیدروکسی پروژسترون) قبل و 3 ماه بعد از مطالعه چک می شود.
گروه مداخله: افراد مبتلا به سندروم تخمدان پلی کیستیک که علاوه بر درمان روتین ورزش یوگا را به مدت 6 هفته ( هفته ای یکبار آموزش حضوری در سالن تحت نظر مربی و 5 بار در هفته انجام تمرینات یوگا تخمدان در منزل با استفاده از آموزش های حضوری قبلی و بسته آموزشی به مدت 1 ساعت که شامل 45 دقیقه تمرینات آسانا و سپس 15 دقیقه آرام سازی عمیق خواهد بود)، انجام خواهند داد. جهت پیگیری انجام تمرینات در منزل با افراد نمونه در هفته تماس برقرار خواهد شد و چک لیست انجام تمرینات توسط افراد پژوهش تکمیل خواهد شد. پرسشنامه کیفیت زندگی PCOS تکمیل می گردد وسو نوگرافی دو بعدی تخمدان و آزمایشات (، testesteron ، دهیدرواپی آندروسترون سولفات و17- سطح هیدروکسی پروژسترون) قبل و 3 ماه بعد از مطالعه چک می شود.
گروه مداخله: افراد مبتلا به سندروم تخمدان پلی کیستیک که علاوه بر درمان روتین ورزش یوگا را به مدت 6 هفته ( هفته ای یکبار آموزش حضوری در سالن تحت نظر مربی و 5 بار در هفته انجام تمرینات یوگا تخمدان در منزل با استفاده از آموزش های حضوری قبلی و بسته آموزشی به مدت 1 ساعت که شامل 45 دقیقه تمرینات آسانا و سپس 15 دقیقه آرام سازی عمیق خواهد بود)، انجام خواهند داد. جهت پیگیری انجام تمرینات در منزل با افراد نمونه در هفته تماس برقرار خواهد شد و چک لیست انجام تمرینات توسط افراد پژوهش تکمیل خواهد شد. پرسشنامه کیفیت زندگی PCOS تکمیل می گردد وسو نوگرافی دو بعدی تخمدان و آزمایشات پروفایل لیپید (شامل ldl, hdl,trigliserid ,cholestrol) و آزمایشات (amh، fsh، esteradiol testesteron ،tsh، پرولاکتین، دهیدرواپی آندروسترون سولفات و17- سطح هیدروکسی پروژسترون) قبل و 3 ماه بعد از مطالعه چک می شود.
Protocol summary
Study aim
Determining the effect of yoga on improving the clinical symptoms of polycystic ovary syndrome in infertile women
Design
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.
Settings and conduct
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
Participants/Inclusion and exclusion criteria
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
Intervention groups
The intervention group includes people practicing yoga.
The control group includes people who do not receive any specific treatment.
Main outcome variables
Polycystic ovary syndrome
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20220317054318N5
Registration date:2023-08-13, 1402/05/22
Registration timing:registered_while_recruiting
Last update:2026-08-20, 1405/05/29
Update count:2
Registration date
2023-08-13, 1402/05/22
Registrant information
Name
Shamim Pilevari
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 81 3827 7012
Email address
sh.pilevar@umsha.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-07-23, 1402/05/01
Expected recruitment end date
2024-07-22, 1403/05/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluate the effect of yoga on improving the clinical symptoms of polycystic ovary syndrome in infertile women
Public title
The effect of yoga on polycystic ovaries
Purpose
Treatment
Inclusion/Exclusion criteria
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
Age
From 18 years old to 35 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
128
Randomization (investigator's opinion)
Randomized
Randomization description
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.
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 Hamadan University of Medical Sciences
Street address
Fatemieh Hospital, Pasdaran Street
City
Hamadan
Province
Hamadan
Postal code
۶۵۱۷۸۳۸۷۳۶
Approval date
2023-07-01, 1402/04/10
Ethics committee reference number
IR.UMSHA.REC.1402.277
Health conditions studied
1
Description of health condition studied
Polycystic ovary syndrome
ICD-10 code
E28.2
ICD-10 code description
Polycystic ovarian syndrome
Primary outcomes
1
Description
Polycystic ovary syndrome
Timepoint
Investigating the symptoms of polycystic ovary syndrome at the beginning of the study and then 2 months after yoga exercises
Method of measurement
Through the quality of life questionnaire for patients with polycystic ovary syndrome and two-dimensional ovarian ultrasound
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: People with polycystic ovary syndrome who in addition to routine treatment practice yoga for 6 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.
Category
Treatment - Other
2
Description
Control group: People with polycystic ovary syndrome who receive routine treatment including folic acid supplementation.
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Fatemiyah Hospital
Full name of responsible person
Shamim Pilevari
Street address
Fatemieh Hospital, Pasdaran Street,
City
Hamedan
Province
Hamadan
Postal code
۶۵۱۷۸۳۸۶۷۸
Phone
+98 81 3827 7013
Email
Sh.pilehvari@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Reza Shokohi
Street address
5th floor, Central Headquarters of University of Medical Sciences, Shahid Fahmideh Blvd., Hamadan, Hamedan
City
Hamadan
Province
Hamadan
Postal code
۶۵۱۷۸۳۸۶۷۸
Phone
+98 81 3131 4058
Email
Fanavari@umsha.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Hamedan 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
Hamedan University of Medical Sciences
Full name of responsible person
Shamim Pilehvari
Position
Assistant Professor
Latest degree
Subspecialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Fatemieh Hospital, Pasdaran Street
City
Hamedan
Province
Hamadan
Postal code
۶۵۱۷۸۳۸۶۷۸
Phone
+98 81 3827 7013
Email
Sh.Pilehvari@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Shamim Pilehvari
Position
Associate professor
Latest degree
Subspecialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Fatemieh Hospital, Pasdaran Street
City
Hamedan
Province
Hamadan
Postal code
۶۵۱۷۸۳۸۶۷۸
Phone
+98 81 3827 7013
Email
Sh.Pilehvaei@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Shamim Pilehvari
Position
Associate professor
Latest degree
Subspecialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Pasdaran Street, Fatemieh Hospital
City
Hamedan
Province
Hamadan
Postal code
۶۵۱۷۸۳۸۶۷۸
Phone
+98 81 3827 7013
Email
Sh.Pilehvari@yahoo.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