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IRCT20251230068496N1 IRCT 2026-01-03 Mashhad University of Medical Sciences The Effect of Counseling Based on the Sexual Health Model on Women's Sexual Well-Being after Failure of Assisted Reproductive Technology The Effect of Counseling Based on the Sexual Health Model on Women's Sexual Well-Being after Failure of Assisted Reproductive Technology 2026-02-20 anticipated 68 Complete https://irct.ir/trial/88435 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Education/Guidance, 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. N/A Sexual Well-Being. Intervention 1: 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. Intervention 2: Control group: Participants in the intervention group will receives routine care provided by Milad Infertility Center. Yes - There is a plan to make this available What will be shared: 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: Access will commence alongside the publication of articles derived from the thesis To whom: 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. Conditions: 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 Where to obtain: By email to the corresponding author of the paper. How to obtain: 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 Comments:
public Fatemeh Zahra Karimi
Khwarazmi Educational Complex, Ferdowsi University of Mashhad Main Campus, Adjacent to the East Gate, Azadi Square, Mashhad, Iran
Mashhad Iran (Islamic Republic of) 9137913199 0098 51 3884673 Karimifz@mums.ac.ir Mashhad University of Medical Sciences scientific Fatemeh Zahra Karimi
Khwarazmi Educational Complex, Ferdowsi University of Mashhad Main Campus, Adjacent to the East Gate, Azadi Square, Mashhad, Iran
Mashhad Iran (Islamic Republic of) 9137913199 0098 51 3884673 Karimifz@mums.ac.ir Mashhad University of Medical Sciences Iran (Islamic Republic of) 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. 19 years 45 years Female 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 Behavior Behavior 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. Control group: Participants in the intervention group will receives routine care provided by Milad Infertility Center. 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). Mashhad University of Medical Sciences Approved 2025-12-29 Research Ethics Committee, Faculty of Nursing and Midwifery, Mashhad University of Medical Sciences School of Nursing and Midwifery, Khorrami Educational Complex, Mashhad University of Medical Sciences Mashhad Razavi Khorasan Iran (Islamic Republic of)