Protocol summary

Summary
(1) Objectives: The aim of this study is to determine the effect of yoga on Quality Life, In vitro fertilisation Outcomes and Signs of Women With Poly Cystic Ovary Syndrom Undergoing Infertility Treatment.(2) Design: Participations are divided into 2 groups(yoga-control).(3) Setting and Conduct: In this quasi- experimental research, 62 patients of Poly Cystic Ovary Syndrom Undergoing Infertility Treatment.(4)Inclusion Criteria: Have primitive infertility, Candidate initial period in vitro fertilization treatment, Body mass index: 20-35, Do not have any type of hormone therapy 3 months before arrival to study, Complete the testimonial form before arrival to study, Do not have problem in doing physical exercises.Exclusion Criteria: Create any type of body and mental stress during the study..(5) Intervention : They will practice(yoga) for 6 weeks,7 days,90 minutes in any session.(6) Main outcome: Quality Life, In vitro fertilisation Outcomes and Signs is the main variable in this article.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2016012326158N1
Registration date: 2016-03-14, 1394/12/24
Registration timing: prospective

Last update:
Update count: 0
Registration date
2016-03-14, 1394/12/24
Registrant information
Name
Maryam Mohseni
Name of organization / entity
Iran University of Medical Sciences, School of nursing and midwifery
Country
Iran (Islamic Republic of)
Phone
+98 31 5551 4009
Email address
mohseni.m@tak.iums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Iran University of Medical Sciences
Expected recruitment start date
2016-03-20, 1395/01/01
Expected recruitment end date
2016-05-20, 1395/02/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Effect OF Yoga on Quality Life, In Vitro Fertilisation Outcomes and Signs of Women With Poly Cystic Ovary Syndrom Undergoing Infertility Treatment.
Public title
The Effect OF Yoga on Quality Life, In Vitro Fertilisation Outcomes and Signs of Women With Poly Cystic Ovary Syndrom Undergoing Infertility Treatment.
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion Criteria: Have primitive infertility, Candidate initial period in vitro fertilization treatment, Body mass index: 20-35, Do not have any type of hormone therapy 3 months before arrival to study, Complete the testimonial form before arrival to study, Do not have problem in doing physical exercises.Exclusion Criteria: Create any type of body and mental stress during the study.
Age
From 18 years old to 49 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 62
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Participations are divided into 2 groups(yoga-control)

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Iran University of Medical Sciences
Street address
School of nursing and midwifery,Yasemi Rashid street, Valiasr street. Tehran.
City
Tehran
Postal code
Approval date
2016-01-23, 1394/11/03
Ethics committee reference number
IR.IUMS.REC.1394.9311373025

Health conditions studied

1

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

Primary outcomes

1

Description
Quality of life Rate
Timepoint
Patients are tested twice for quality of life rate.(one day before the first day of training – one day after the final day training course).
Method of measurement
Modified polycystic ovary syndrome questionnaire

Secondary outcomes

1

Description
In vitro fertilisation Outcomes
Timepoint
after the final day training course
Method of measurement
number of fetus

Intervention groups

1

Description
Intervention group: Yoga exercise must be done for 6 weeks (7 times a week- 90 minutes).pations will practice yoga exercise in same time and same place.
Category
Treatment - Other

2

Description
Control group :Without intervention
Category
Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Sarem Hospital
Full name of responsible person
Maryam Mohseni
Street address
Tehran , Ekbatan
City
Tehran

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice chancellor for research, Iran University of Medical Sciences
Full name of responsible person
morteza naserbakht
Street address
Iran University of Medical Sciences, Next to Milad tower, Hemmat highway, Tehran.
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research, Iran University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty

Person responsible for general inquiries

Contact
Name of organization / entity
Iran University of Medical Sciences, School of nursing and midwifery
Full name of responsible person
Maryam Mohseni
Position
MSc student of Midwifery
Other areas of specialty/work
Street address
Blook Ghadir 87,phase 2, Khatamolanbia,Kashan
City
kashan
Postal code
Phone
+98 983155322143
Fax
Email
maryam16170@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Iran University of Medical Sciences, School of Nursing and Midwifery
Full name of responsible person
Leila Amini
Position
assisstant of professor
Other areas of specialty/work
Street address
School of nursing and midwifery,Yasemi Rashid street, Valiasr street. Tehran.
City
Tehran
Postal code
Phone
+98 21 4365 1820
Fax
Email
Amini.l@iums.ac.ir
Web page address

Person responsible for updating data

Contact

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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