Investigating the effect of training based on spouse's support on anxiety, perceived social support, and infertility treatment outcomes in women undergoing assisted reproductive technology
Determining the effect of training based on spouse's support on anxiety, perceived social support, and infertility treatment outcomes in women undergoing assisted reproductive technology
Design
This clinical trial with a control group will be conducted in parallel and without blinding on 86 infertile women. Samples will be taken continuously and then randomly assigned to two intervention and control groups by block of four.
Settings and conduct
This study will be conducted at Arash Hospital in Tehran. The Perceived Social Support and Anxiety Questionnaire and treatment outcomes will be completed before and after the intervention on the day of oocyte retrieval.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Iranian nationality; ≥3 weeks before IVF/ICSI start; at least basic literacy; husband’s smartphone/internet access; cohabiting couples; primary/secondary infertility(secondary infertility with no history of live birth). Exclusion criteria: Chronic illness (e.g., diabetes, hypertension); reported mental illness in either partner; use of psychotropic/neuroactive drugs; adopted children; intention to use donor oocytes, frozen eggs, or surrogacy; IVF for sex selection; current psychological counselling; education in psychology/counselling; severe marital conflict in the week before prior to study entry. Withdrawal criteria: Stressful life event during intervention; treatment cycle cancellation (withdrawal, poor ovarian response, husband absent on retrieval day); spontaneous pregnancy; referral to psychologist during study; husband’s failure to follow virtual training.
Intervention groups
The intervention group receives support from their husbands, who are trained during 4 sessions, during the treatment.
Main outcome variables
Perceived social support, anxiety, and treatment outcomes.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20181207041873N5
Registration date:2025-11-26, 1404/09/05
Registration timing:prospective
Last update:2025-11-26, 1404/09/05
Update count:0
Registration date
2025-11-26, 1404/09/05
Registrant information
Name
Seyedeh Batool Hasanpoor-Azghady
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 2286 0021
Email address
hasanpoor.sb@iums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2025-12-06, 1404/09/15
Expected recruitment end date
2026-09-23, 1405/07/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the effect of training based on spouse's support on anxiety, perceived social support, and infertility treatment outcomes in women undergoing assisted reproductive technology
Public title
The effect of training based on spouse's support on anxiety, perceived social support, and infertility treatment outcomes in women undergoing assisted reproductive technology
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Iranian nationality of the couple
Having at least three weeks until the start of the IVF or ICSI treatment protocol
Having at least some literacy
Access to a smartphone and the internet by the infertile woman's husband
Couples living together
Having primary or secondary infertility(secondary infertility with no history of live birth)
Exclusion criteria:
Having any chronic physical illness such as diabetes, high blood pressure
Having mental illness in either partner, according to their report
Taking medications that affect the nervous system or psychotropic drugs by a couple
Having adopted children
Having children with secondary infertility
Intention to use donated oocytes
Intention to use frozen eggs
Intention to use a surrogacy
Sex selection using IVF
Each partner undergoing psychological counselling
Education in psychology and counselling
Intense arguments during the week leading up to the start of the study
Age
No age limit
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
86
Randomization (investigator's opinion)
Randomized
Randomization description
Eligible individuals are continuously enrolled in the study and then randomly assigned to the experimental and control groups using blocks of four. The randomisation list is generated randomly online via https://www.sealedenvelope.com (a website for generating block randomisation sequences) in a one-to-one ratio by an individual outside the research team.
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 Committees of Iran University of Medical Sciences
Street address
Iran University of Medical Sciences Hemmat Expressway, Near Milad Tower Tehran, Iran
City
Tehran
Province
Tehran
Postal code
۱۴۴۹۶۱۴۵۳۵
Approval date
2025-09-27, 1404/07/05
Ethics committee reference number
IR.IUMS.NURSE.REC.1404.002
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
Differences or lack of differences in perceived social support among infertile women undergoing in vitro fertilization (ivf) treatment
Timepoint
Before the intervention and after the intervention on the day of oocyte retrieval
Method of measurement
Multidimensional Perceived Social Support Scale (MSPSS)
Secondary outcomes
1
Description
Differences or lack of differences, in anxietyamong infertile women undergoing in vitro fertilization (ivf) treatment
Timepoint
Before the intervention and after the intervention on the day of oocyte retrieval
Method of measurement
State-Trait Anxiety Inventory, just state anxiety
2
Description
Difference or lack of difference in treatment outcomes in infertile women undergoing in vitro fertilization (ivf) treatment
Timepoint
After the intervention when the results are known
Method of measurement
The number of eggs is determined through microscopic examination, and the quality of the eggs and embryos, as well as the number of embryos, is assessed using a microscope and according to agreed-upon guidelines by the embryologist.
Intervention groups
1
Description
The intervention is designed to train husbands of infertile women undergoing IVF/ICSI treatment so that infertile women will be supported by their trained husbands when they begin the treatment cycle. For this purpose, the training of the husbands of the intervention group will be completed before the start of the treatment cycle of infertile women. The training will be conducted virtually by the researcher in 4 sessions of 30-45 minutes by sending educational videos on WhatsApp messenger, with the time interval between sending educational videos being every 5 days. The content of the training sessions for the husbands of the intervention group is as follows: First session: Introduction to the female reproductive system and natural fertilization, introduction to IVF and ICSI and reasons for use, drug preparation, ultrasound and egg retrieval, the husband's supportive role in these stages. Second session: Anxiety during treatment and the problems caused by it, simple anxiety reduction techniques, basic support skills to reduce women's anxiety, extensive social support (family and friends). Session 3: The importance of adequate sleep and the role of the husband in providing a comfortable environment for sleep, healthy nutrition and helping the wife in preparing and choosing the right food, light exercise and encouraging women to move with their husbands, husbands avoiding unhealthy behaviors, husbands taking care of themselves so that they can support women. Session 4: The concept of empathy and examples of it in the treatment process, active listening and examples of it in the treatment process, asking about women's thoughts and feelings, effective companionship methods during treatment, strategies for improving communication and emotional bonding. Infertile women in the intervention group will be supported by their trained husbands during the treatment cycle. The intervention group will also receive routine infertility center consultations from the treatment team, which will include explanations about the fertility treatment method and how to use infertility drugs and their side effects. Finally, they will complete two questionnaires on perceived social support and a state anxiety questionnaire on the day of egg retrieval, while waiting for their turn to undergo the egg retrieval procedure. The number and quality of embryos will also be determined on the third or fifth day after in vitro fertilization using a microscope and based on the embryologist's agreed guidelines.
Category
Lifestyle
2
Description
Control group: The control group will receive routine infertility center consultations from the treatment team, which include explanations about the fertility treatment method and how to use infertility drugs and its side effects. Like the intervention group, they will complete two perceived social support questionnaires and a state anxiety questionnaire on the day of egg retrieval, while waiting for their turn to undergo the egg retrieval procedure. The number and quality of embryos will also be determined on the third or fifth day after in vitro fertilization using a microscope and based on guidelines agreed upon by the embryologist.
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Arash hospital
Full name of responsible person
Maryam Moradi
Street address
Arash hospital, Rashid North St, Resalat Hwy, Tehran.
City
Tehran
Province
Tehran
Postal code
1653915981
Phone
+98 21 7788 3283
Fax
+98 21 7788 3196
Email
Maryammoradi1478@gmail.com
Web page address
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Majid Safa
Street address
Iran University of Medical Sciences, Hemmat Expressway, Near Milad Tower
City
Tehran
Province
Tehran
Postal code
۱۴۴۹۶۱۴۵۳۵
Phone
+98 21 86701
Email
PR@iums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Iran University of Medical Sciences
Proportion provided by this source
50
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
Iran University of Medical Sciences
Full name of responsible person
Seyede Batool Hasanpoor-Azghady
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Reproductive Health
Street address
No. 1996713883, Rashid Yasemi Ave., Valiance Ave., School of Nursing & Midwifery
City
Tehran
Province
Tehran
Postal code
۱۹۹۶۷۱۳۸۸۳
Phone
+98 21 2288 5394
Email
hasanpoor.sb@iums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Seyede Batool Hasanpoor-Azghady
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Reproductive Health
Street address
No. 1996713883, Rashid Yasemi Ave., Valiance Ave., School of Nursing & Midwifery
City
Tehran
Province
Tehran
Postal code
۱۹۹۶۷۱۳۸۸۳
Phone
+98 21 2288 5394
Email
hasanpoor.sb@iums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Seyede Batool Hasanpoor-Azghady
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Reproductive Health
Street address
No. 1996713883, Rashid Yasemi Ave., Valiance Ave., School of Nursing & Midwifery
City
Tehran
Province
Tehran
Postal code
۱۹۹۶۷۱۳۸۸۳
Phone
+98 21 2288 5394
Email
hasanpoor.sb@iums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is 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
Yes - There is 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
Title and more details about the data/document
Only part of the information, such as information on the main outcome or the like, can be shared
When the data will become available and for how long
Start the access period 6 months after publishing the results
To whom data/document is available
Data for researchers and people who are engaged in treatment can apply for them
Under which criteria data/document could be used
Data for researchers and people who are engaged in treatment can apply for them
From where data/document is obtainable
by Email maryammoradi1478@gmail.com
What processes are involved for a request to access data/document