Determining the impact of counseling based on the sexual health model on women's sexual well-being after failure of assisted reproductive technology
Design
A randomized, controlled , parallel-group, unblinded, superiority clinical trial is conducted on 68 women after failed assisted reproductive technology. The website www.Randomization.com was used for randomization.
Settings and conduct
face-to-face and group sessions will be held in four 90-minute sessions weekly at Milad Infertility Center for the intervention group.
Participants/Inclusion and exclusion criteria
Inclusion criteria included: women aged between 19 and 45 years old, ability to read and write, being in a monogamous marriage, having confirmed primary infertility, history of undergoing at least one of the assisted reproductive technology method, having passed at least 6 months since infertility treatment failure, not undergoing infertility treatment at present and within the past six months, not having a known physical or psychiatric illness affecting sexual life, and having had sexual intercourse within the past month; and the study exclusion criteria included: absence from more than one intervention session, occurrence of major stressful events during the study, and participating in a similar intervention.
Intervention groups
The intervention group will receive four 90-minute face-to-face group counseling sessions based on the sexual health model, conducted at one-week intervals, to evaluate the effect of the intervention on sexual well-being. The control group will receive routine care provided by the infertility center.
Main outcome variables
sexual well-being
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20251230068496N1
Registration date:2026-01-03, 1404/10/13
Registration timing:prospective
Last update:2026-01-03, 1404/10/13
Update count:0
Registration date
2026-01-03, 1404/10/13
Registrant information
Name
Fateme Jahanbakhshi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 44 3367 5236
Email address
jahanbakhshif4022@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2026-02-20, 1404/12/01
Expected recruitment end date
2026-08-23, 1405/06/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Effect of Counseling Based on the Sexual Health Model on Women's Sexual Well-Being after Failure of Assisted Reproductive Technology
Public title
The Effect of Counseling Based on the Sexual Health Model on Women's Sexual Well-Being after Failure of Assisted Reproductive Technology
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Have informed consent to participate in the study.
Be Iranian and a resident of Mashhad.
Be in the age range of 19 to 45 years
Be able to read and write
Have a contact phone number.
Have confirmed primary infertility.
Be officially married.
Be the only wife of their husband.
Have no adopted child.
Have had sexual intercourse within the last month.
Failure of at least one assisted reproductive technology cycle (ZIFT, GIFT, IVF, IUI, ICSI)
At least six months have passed since the last infertility treatment failure.
Not undergoing infertility treatment at present and during the past six months.
Not having a known physical illnesses affecting sexual life.
Not having a known psychiatric disorders affecting sexual life
No occurrence of major stressful life events for the couple during the past six months.
Not using medications known to affect sexual life.
No use of tobacco products, alcohol, or illicit drugs.
No participation in sexual education or counseling sessions at present or during the past six months.
Exclusion criteria:
Unwillingness to continue participation in the study
absence from more than one intervention session
Occurrence of stressful events during the study
Participation in the same intervention during the study
Age
From 19 years old to 45 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
68
Randomization (investigator's opinion)
Randomized
Randomization description
Eligible individuals are randomly assigned to either the intervention group or the control group using simple randomization and the random number generation function available on the Randomization.com website. The allocation codes are placed inside opaque, sealed envelopes. Specifically, as each eligible participant enter the study, one of these envelopes is opened, and based on the code inside, the participant is assigned to either the 'counseling' or 'control' group. After completing the allocation of participants to the two groups, and to prevent the exchange of information between members of the different groups, the intervention is initiate.
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
Research Ethics Committee, Faculty of Nursing and Midwifery, Mashhad University of Medical Sciences
Street address
School of Nursing and Midwifery, Khorrami Educational Complex, Mashhad University of Medical Sciences
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913199
Approval date
2025-12-29, 1404/10/08
Ethics committee reference number
IR.MUMS.NURSE.REC.1404.110
Health conditions studied
1
Description of health condition studied
Sexual Well-Being
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Sexual Well-Being
Timepoint
Before, immediately after, and one month after the end of the intervention
Method of measurement
The Natsal Sexual Wellbeing Measure (Natsal-SW)
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Participants in the intervention group will receive four 90-minute face-to-face group counseling sessions based on the Sexual Health Model at the Milad Infertility Center, conducted at one-week intervals. The counseling content will include: Session 1, establishing initial contact; assessing participants’ knowledge of sexual well-being; providing opportunities to express existing concerns; discussion of the dimensions of the Sexual Health Model (including talking about sex, culture and sexual identity, sexual health care, and safe sex); and assignment of homework. Session 2, review of homework; discussion of the dimensions of the Sexual Health Model (including anatomy and sexual function, challenges, and body image); and assignment of homework. Session 3, review of homework; discussion of the dimensions of the Sexual Health Model (including positive sexuality, sexual fantasies, relationships, and intimacy); and assignment of homework. Session 4, review of homework; discussion of the spirituality dimension of the Sexual Health Model; and review of the course content, clarification of ambiguities, and evaluation of the intervention.
Category
Behavior
2
Description
Control group: Participants in the intervention group will receives routine care provided by Milad Infertility Center.
Category
Behavior
Recruitment centers
1
Recruitment center
Name of recruitment center
Milad Infertility Center
Full name of responsible person
Fatemeh Zahra Karimi
Street address
Milad Infertility Center, Imam Reza Hospital, Ibn Sina Street, Tagiabad Square
City
Mashhad
Province
Razavi Khorasan
Postal code
1355691359
Phone
+98 51 3854 3031
Email
karimifz@mums.ac.ir
Web page address
https://emamreza.mums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Dr. Mahmud Shabestari
Street address
Khwarazmi Educational Complex, Ferdowsi University of Mashhad Main Campus, Adjacent to the East Gate, Azadi Square, Mashhad, Iran
City
Mashhad
Province
Razavi Khorasan
Postal code
9177949025
Phone
+98 51 3882 9278
Fax
+98 51 3882 9278
Email
khm@mums.ac.ir
Web page address
https://nurse.mums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mashhad 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
Mashhad University of Medical Sciences
Full name of responsible person
Fatemeh Zahra Karimi
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Midwifery
Street address
Khwarazmi Educational Complex, Ferdowsi University of Mashhad Main Campus, Adjacent to the East Gate, Azadi Square, Mashhad, Iran
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913199
Phone
0098 51 3884673
Email
Karimifz@mums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Fatemeh Zahra Karimi
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Midwifery
Street address
Khwarazmi Educational Complex, Ferdowsi University of Mashhad Main Campus, Adjacent to the East Gate, Azadi Square, Mashhad, Iran
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913199
Phone
0098 51 3884673
Email
Karimifz@mums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Fateme Jahanbakhshi
Position
Master's student
Latest degree
Bachelor
Other areas of specialty/work
Counselling in Midwifery
Street address
Baharestan Enghelab Female Dormitory, Mashhad University of Medical Sciences Campus, End of Bahonar Blvd, Vakilabad 2, Vakilabad Blvd
City
Mashhad
Province
Razavi Khorasan
Postal code
9177943707
Phone
+98 44 3367 5236
Fax
Email
JahanbakhshiF4022@mums.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
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
The data used in this study include scores for sexual well-being and demographic characteristics. These data will be reported solely in numerical form and as mean scores. The identities of the participants will remain confidential and will be kept solely by the researcher.
When the data will become available and for how long
Access will commence alongside the publication of articles derived from the thesis
To whom data/document is available
Access to thesis will be available for researchers and medical science students in Mashhad, and access to related articles will be open to all researchers.
Under which criteria data/document could be used
Members of scientific organizations affiliated with the relevant institution may, upon request and with due respect for data ownership and explicit referencing to the original study, utilize these materials in their own research
From where data/document is obtainable
By email to the corresponding author of the paper.
What processes are involved for a request to access data/document
Upon receiving the applicant's request (including self-introduction and request details), the necessary information will be promptly reviewed and sent to the corresponding author