To assess the effect of lifestyle counseling versus control group on premature ovarian insufficiency in infertile women
Design
This is a randomized clinical trial with control group, in which 72 eligible patients will be randomly assigned through the drawing a lot to the intervention and control groups
Settings and conduct
This study will be performed in the Fatemieh Hospital in Hamadan city on eligible infertile women with premature ovarian insufficiency. The patients will be randomly assigned to the intervention and control groups through the drawing a lot. Blinding is not possible in this study.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
Age between 18 and 45 years old;
Being married;
Reduced ovarian size and volume;
Increased FSH and decreased AMH levels;
Exclusion criteria:
Polygamy of the husband;
Psychological disorders;
Sexual dysfunction;
Hormone use within the past 6 months.
Intervention groups
Intervention group:
Routine treatment plus weekly lifestyle modification counseling sessions for 8 sessions
Control group
Routine medical care
Main outcome variables
Primary outcome:
The lifestyle, the size and volume of the ovaries and follicles
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20120215009014N477
Registration date:2023-07-24, 1402/05/02
Registration timing:registered_while_recruiting
Last update:2023-07-24, 1402/05/02
Update count:0
Registration date
2023-07-24, 1402/05/02
Registrant information
Name
Jalal Poorolajal
Name of organization / entity
Department of Epidemiology & Biostatistics Hamadan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 81 1838 0090
Email address
poorolajal@umsha.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-07-23, 1402/05/01
Expected recruitment end date
2023-10-22, 1402/07/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of lifestyle counseling versus control group on premature ovarian insufficiency in infertile women: a randomized clinical trial
Public title
Effect of lifestyle counseling versus control group on premature ovarian insufficiency in infertile women
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age between 18 and 45 years old
Being married
Reduced ovarian size and volume
Increased FSH and decreased AMH levels
Exclusion criteria:
Polygamy of the husband
Psychological disorders
Sexual dysfunction
Hormone use within the past 6 months.
Age
From 18 years old to 45 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
72
Randomization (investigator's opinion)
Randomized
Randomization description
Random assignment of the right and left sides of the patients to the intervention and control groups through the drawing of lots. To do this, we prepare two sheets and write "right" on one sheet and "left" on another. Then, by referring to every patient, one of the sheets will be randomly taken. According to whether the sheet is taken right or left is assigned to the intervention group and the other side to the control group.
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
Vice-chancellor for Research and Technology, Hamadan University of Medical Sciences, Shahid Fahmideh Ave
City
Hamadan
Province
Hamadan
Postal code
6517838695
Approval date
2023-07-01, 1402/04/10
Ethics committee reference number
IR.UMSHA.REC.1402.279
Health conditions studied
1
Description of health condition studied
Female infertility
ICD-10 code
N97
ICD-10 code description
Female infertility
Primary outcomes
1
Description
The lifestyle
Timepoint
Before and 4 weeks after the intervention
Method of measurement
Using the Walker's Health Promotion Lifestyle Questionnaire
2
Description
The size and volume of the ovaries and follicles
Timepoint
Before and 4 weeks after the intervention
Method of measurement
Using ultrasound imaging
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Routine treatment plus weekly lifestyle modification counseling sessions for 8 sessions (including: the impact of physical activity on hormone balance, ways to control stress and its relationship with hormonal disorders and lack of ovulation, exercise techniques to manage stress such as yoga and light walking, understanding the role of nutrition in premature ovarian failure, eliminating carbohydrates and harmful foods, substituting with healthier food options, ways to lose weight without starving, understanding suitable sleeping patterns, identifying the root causes of sleep disorders, and coping strategies for anxiety)
Category
Treatment - Other
2
Description
Control groupRoutine medical care
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Fatemieh Hospital in Hamadan city
Full name of responsible person
Mehrnoosh Hosseinpur
Street address
Fatemieh Hospital, Pasdaran Ave.
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0572
Email
mehrnoosh.hosseinpur@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Dr. Reza Shokoohi
Street address
Hamadan University of Medical Sciences, Shahid Fahmideh Ave
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0717
Email
info.research@umsha.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
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
Mehrnoosh Hosseinpur
Position
Midwifery Student
Latest degree
Master
Other areas of specialty/work
Midwifery
Street address
School of Nursing and Midwifery, Hamadan University of Medical Sciences, Shahid Fahmideh Ave.
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0572
Email
mehrnoosh.hosseinpur@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Dr. Farideh Kazemi
Position
Reproductive Health Specialist
Latest degree
Ph.D.
Other areas of specialty/work
Reproductive Health
Street address
School of Nursing and Midwifery, Hamadan University of Medical Sciences, Shahid Fahmideh Ave.
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0572
Email
faridehkazemi21@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Dr. Jalal Poorolajal
Position
Professor of Epidemiology
Latest degree
Ph.D.
Other areas of specialty/work
Epidemiology
Street address
School of Public Health, Hamadan University of Medical Sciences, Shahid Fahmideh Ave
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0090
Email
poorolajal@umsha.ac.ir
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