To assess the effect of counseling versus control group on fertility knowledge and childbearing attitude among infertile couples
Design
This is a Phase III randomized clinical trial with a control group with parallel groups, in which eligible patients will be randomly assigned to the intervention and control groups using drawing of lots.
Settings and conduct
This study will be conducted at the Comprehensive Health Centers in Hamadan city, involving 102 eligible infertile couples. The patients will be randomly assigned to the intervention and control groups through the drawing of lots. However, it should be noted that blinding is not feasible in this trial.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
Age 18 to 35 years
Infertility for at least 3 years
Being literate
Ability to speak Persian
Internet access
Exclusion criteria:
Using contraceptive methods
History of addiction or mental disorders
Intervention groups
Intervention group:
Routine care and recommendations, in addition to Gather method counseling for 45 to 60 minutes, one session per week for 4 sessions
Control group:
Routine care and recommendations
Main outcome variables
Primary outcome:
The mean fertility knowledge score, the mean score of childbearing attitude
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20120215009014N509
Registration date:2024-05-04, 1403/02/15
Registration timing:prospective
Last update:2024-05-04, 1403/02/15
Update count:0
Registration date
2024-05-04, 1403/02/15
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
2024-05-21, 1403/03/01
Expected recruitment end date
2024-11-15, 1403/08/25
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of counseling versus control group on fertility knowledge and childbearing attitude among infertile couples: a randomized clinical trial
Public title
Effect of counseling versus control group on fertility knowledge and childbearing attitude among infertile couples
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age 18 to 35 years
Infertility for at least 3 years
Being literate
Ability to speak Persian
Internet access
Exclusion criteria:
Using contraceptive methods
History of addiction or mental disorders
Age
From 18 years old to 35 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
102
Randomization (investigator's opinion)
Randomized
Randomization description
Random allocation of patients to intervention and control groups by lottery. For this purpose, we prepare two sheets, write "intervention" on one and "control" on the other. Then, with each patient's visit, one of the sheets is randomly taken and the patient is assigned to the intervention or 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, Fahmideh Ave
City
Hamadan
Province
Hamadan
Postal code
6517838695
Approval date
2024-04-20, 1403/02/01
Ethics committee reference number
IR.UMSHA.REC.1403.027
Health conditions studied
1
Description of health condition studied
Infertility
ICD-10 code
N97
ICD-10 code description
Female infertility
Primary outcomes
1
Description
The mean fertility knowledge score
Timepoint
Before the intervention and one month later
Method of measurement
Using the Cardiff questionnaire
2
Description
The mean score of childbearing attitude
Timepoint
Before the intervention and one month later
Method of measurement
Using the Soderberg questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Routine care and recommendations, in addition to Gather method counseling for 45 to 60 minutes, one session per week for 4 sessions (including assessment of needs, beliefs, feelings, choices, knowledge and experiences related to having children; personal and social complications of not having children; referring to the role of the child in the relationship; strengthening the sense of responsibility and strength of family relationships; the importance of having children in medicine and Islam; referring to the problem of population aging; getting to know the anatomy of the male and female reproductive system; healthy lifestyle before pregnancy; physiology of pregnancy, physical and psychological benefits of pregnancy; disadvantages of pregnancy at an advanced age; brief description of pregnancy symptoms; the proper way of spacing between pregnancies, and mental injuries related to single children)
Category
Other
2
Description
Control group: Routine care and recommendations
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Comprehensive Health Centers in Hamadan city
Full name of responsible person
Sanaz Javadi Yeganeh
Street address
School of Nursing and Midwifery, Hamadan University of Medical Sciences, Fahmideh Ave.
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0572
Email
sanazjavadi931@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, 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
Sanaz Javadi Yeganeh
Position
Midwifery Student
Latest degree
Master
Other areas of specialty/work
Midwifery
Street address
School of Nursing and Midwifery, Hamadan University of Medical Sciences, Fahmideh Ave.
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0572
Email
sanazjavadi931@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Dr. Refat Bakht
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, Fahmideh Ave.
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0572
Email
rbakht@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, 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