Main Objective of the Project: To determine the effect of couples’ coping enhancement training on the marital stress of infertile couples in the control and intervention groups, before and after the intervention.
Design
A randomized, controlled clinical trial with factorial groups, without blinding, on 92 couples.
Settings and conduct
This research is a randomized controlled trial with a concurrent control group, involving infertile couples who will attend the infertility treatment center at Velayat Hospital in Qazvin (Iranian calendar) for infertility treatment and meet the study inclusion criteria.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Infertile couples with high or moderate levels of marital stress.
Exclusion criteria: Less than 12 months of trying to conceive.
Intervention groups
Type of Intervention: Couples Coping Enhancement Training.
Mode of Delivery: Couple-centered, delivered via social media platforms accessible to the couples.
Number of Sessions: 8 sessions, each lasting 40 to 60 minutes.
Control Group:
Routine care.
No intervention will be performed for this group.
At the end of the study, the prepared files will be provided to them, and if necessary, a counseling session will be organized for them.
Main outcome variables
Main Objective of the Project: To determine the effect of couples’ coping enhancement training on the marital stress of infertile couples in the control and intervention groups, before and after the intervention.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20260217068897N1
Registration date:2026-05-17, 1405/02/27
Registration timing:prospective
Last update:2026-05-17, 1405/02/27
Update count:0
Registration date
2026-05-17, 1405/02/27
Registrant information
Name
Elham Ghajar
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 28 3255 7100
Email address
e.ghajar@qums.ac.ir
Recruitment status
recruiting
Funding source
Expected recruitment start date
2026-06-22, 1405/04/01
Expected recruitment end date
2026-12-22, 1405/10/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the effect of Couple Coping Enhancement Training on marital stress of infertile couples
Public title
Investigating the effect of Couple Coping Enhancement Training on marital stress of infertile couples
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
At least 12 months of attempts to conceive, regardless of female or male cause of infertility
A score higher than 34 on the Marital Stress Scale, indicating moderate to high stress
Confirmed diagnosis of infertility by a specialist at the clinic
Informed consent from each spouse individually
Ability to read and use questionnaires
Exclusion criteria:
Having psychotic disorders (psychosis), depression, anxiety disorders, and bipolar disorders, as self-reported by the individual
History of adverse events in the past 6 months, such as the bereavement of a close relative.
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
184
Randomization (investigator's opinion)
Randomized
Randomization description
We will use block randomization with blocks of four. Random allocation sequences will be generated using software for random sequence generation. Block randomization ensures that an equal number of participants are enrolled in the intervention and control groups at regular, sequential intervals. Participants will be evenly distributed between the intervention and control groups using the randomized block method. The selection process for the intervention and control groups will be pre-determined, and participants will be allocated sequentially to the two groups. A random sequence generation website (https://www.sealedenvelope.com/simple-randomiser/v1/lists) will be used.
(CCTT/CTTC/TCCT/CTCT/TCTC/TTC)
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 Qazvin University of Medical Sciences
Street address
Qazvin, Shahid Salmani Street, North Navab Street, Office Complex, Building No. 1 of Qazvin University of Medical Sciences Headquarters
City
Qazvin
Province
Qazvin
Postal code
3419915315
Approval date
2026-01-24, 1404/11/04
Ethics committee reference number
IR.QUMS.REC.1404.431
Health conditions studied
1
Description of health condition studied
Strengthening marital coping for infertile couples
ICD-10 code
ICD-10 code description
2
Description of health condition studied
Marital stress of infertile couples
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Couples with high and moderate marital stress
Timepoint
Before the intervention - one and three months after the completion of the intervention
Method of measurement
Stockholm Marital Stress Questionnaire
Secondary outcomes
1
Description
Marital coping score of infertile couples
Timepoint
Before the intervention - one and three months after the completion of the intervention
Method of measurement
Bodenman Couple Coping Scale
2
Description
Couples' infertility stress score
Timepoint
Before the intervention - one and three months after the completion of the intervention
Method of measurement
Newton Infertility Stress Scale
Intervention groups
1
Description
Intervention group: The couples' coping reinforcement training program, based on the Bodenman and Shantinath guidelines, will be presented in eight 40-60 minute couple-centered sessions on social media platforms accessible to couples.
Category
Behavior
2
Description
Control group: The care is routine and no intervention will be performed for them. At the end of the study, the prepared files will be provided to them and, if needed, a counseling session will be held for them.
Category
Behavior
Recruitment centers
1
Recruitment center
Name of recruitment center
Velayat Hospital
Full name of responsible person
Elham Ghajar
Street address
Velayat Educational and Medical Center, Taiwan Square,22th Brahman Boulevard, Elahieh Alley, Minoudar Street
City
Qazvin
Province
Qazvin
Postal code
3471976161
Phone
+98 28 3379 0620
Email
info@hosvelayat.qums.ac.ir
Web page address
2
Recruitment center
Name of recruitment center
Qazvin University Jihad Organization
Full name of responsible person
Elham Ghajar
Street address
No. 180, East Palestine Street, beginning of Tohid Street, Qazvin
City
Qazvin
Province
Qazvin
Postal code
3415667719
Phone
+98 28 3333 7691
Email
Education@ACECR.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Qazvin University of Medical Sciences
Full name of responsible person
Elham Ghajar
Street address
House Number 12, First door, Begining of Moseyb Moradi Street, Nokhbegan Blvd, Qazvin
City
Qazvin
Province
Qazvin
Postal code
3414968194
Phone
+98 902 524 7249
Email
e.1998.ghagar@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Qazvin 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
Qazvin University of Medical Sciences
Full name of responsible person
Elham Ghajar
Position
Master’s Degree Student in Midwifery Counseling
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
Mvgjkolhdsgkk
City
Qazvin
Province
Qazvin
Postal code
3414968194
Phone
+98 902 524 7249
Email
e.1998.ghagar@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Qazvin University of Medical Sciences
Full name of responsible person
Zainab Alimoradi
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Midwifery
Street address
Qazvin, Shahid Salmani Street, North Navab Street, Office Complex, Building No. 1 of Qazvin University of Medical Sciences Headquarters
City
Qazvin
Province
Qazvin
Postal code
3419915315
Phone
+98 28 3333 3550
Email
z.alimoradi@qums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Qazvin University of Medical Sciences
Full name of responsible person
Elham Ghajar
Position
Master’s Degree Student Midwifery Counseling
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
House Number 12, First door, Begining of Moseyb Moradi Street, Nokhbegan Blvd, Qazvin
City
Qazvin
Province
Qazvin
Postal code
3414968194
Phone
+98 902 524 7249
Email
e.ghajar@qums.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