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IRCT20260711070129N1 IRCT 2026-07-30 Yazd University of Medical Sciences Comparing the Effectiveness of the Empathy, Intimacy, and Sexual Satisfaction (EIS) Counseling Model and the Good Enough Sex (GES) Model on Sexual Function and Infertility-Related Stress in Women with Infertility Comparing the Effectiveness of the Empathy, Intimacy, and Sexual Satisfaction (EIS) Counseling Model and the Good Enough Sex (GES) Model on Sexual Function and Infertility-Related Stress in Women with Infertility 2026-09-23 anticipated 68 Recruiting https://irct.ir/trial/91553 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Education/Guidance, Randomization description: Participants will be allocated to one of the two intervention groups using permuted block randomization with a block size of 4, Blinding description: Random allocation will be performed with allocation concealment, employing sequentially numbered, sealed, opaque envelopes based on the block sequence.Due to the nature of the intervention, blinding of participants and care providers is not feasible; however, the data analyst will remain blinded to the group allocation. N/A infertility. Intervention 1: Intervention group: counseling based on the Empathy, Intimacy, and Sexual Satisfaction (EIS) model. Women in the counseling group based on the Empathy, Intimacy, and Sexual Satisfaction (EIS) model will receive 8 consecutive online sessions, held once a week for 90 minutes by the second researcher, a senior midwifery counseling student who has completed the sexual disorders course and obtained the required certificate, under the supervision of the first researcher, the supervisor (a reproductive health specialist and clinical psychologist) and the third researcher, the consultant professor (a reproductive health specialist), in the Skyroom platform.The sessions will be delivered in the form of educational videos, PowerPoint presentations, lectures, and question-and-answer sessions. At the beginning of each session, a summary of the previous session will be reviewed, and the assignments from the previous session will be evaluated by the first and second researchers to assess progress in each session.The women will be asked to participate in the counseling discussions and raise their questions. The second researcher will also ask questions related to the session topics to encourage greater participation. To facilitate learning, the relevant educational video will also be shown. At the end of each session, a summary of the main points will be presented, participants’ questions will be answered, and the women will be asked to complete their homework assignments before the next session. Intervention 2: Control group: counseling based on the Good Enough Sex (GES) model. Women in the counseling group based on the Good Enough Sex (GES) model will receive 8 consecutive online sessions, held once a week for 90 minutes by the second researcher, a senior midwifery counseling student who has completed the sexual disorders course and obtained the required certificate, under the supervision of the first researcher, the supervisor (a reproductive health specialist and clinical psychologist), and the third researcher, the consultant professor (a reproductive health specialist), in the Skyroom platform.The sessions will be delivered in the form of educational videos, PowerPoint presentations, lectures, and question-and-answer sessions. At the beginning of each session, a summary of the previous session will be reviewed, and the assignments from the previous session will be evaluated by the first and second researchers to assess progress in each session.The women will be asked to participate in the counseling discussions and raise their questions. The second researcher will also ask questions related to the session topics to encourage greater participation. To facilitate learning, the relevant educational video will also be shown. At the end of each session, a summary of the main points will be presented, participants’ questions will be answered, and the women will be asked to complete their homework assignments before the next session. Yes - There is a plan to make this available What will be shared: “The de-identified individual participant data will be available upon request.” When: after the publication of the results To whom: The data will be available to researchers at academic and scientific institutions, as well as those working in the industry, upon request Conditions: "Scientific institutions may submit their formal requests to the project's Principal Investigator via email. Data will be shared following approval from the Ethics Committee of Shahid Sadoughi University of Medical Sciences, Yazd. Conducting further statistical analysis on the provided data is not permitted." Where to obtain: farajkhoda_t@yahoo.com How to obtain: one week after receiving the applicant’s email Comments:
public Fatemeh Adresi
azd, Safaeieh, Bou-Ali Ave, Yazd Research and Clinical Center for Infertility
yazd Iran (Islamic Republic of) 8916877391 +98 35 3824 7085 f.adresi@stu.ssu.ac.ir Yazd University of Medical Sciences scientific Tahmineh Farajkhoda
School of Nursing and Midwifery, Jihad St., Bouali St., Yazd, Iran
Yazd Iran (Islamic Republic of) ۸۹۱۶۸۷۷۳۹۱ +98 35 3824 1751 farajkhoda_t@yahoo.com Yazd University of Medical Sciences Iran (Islamic Republic of) Ability to read and write in PersianHaving an infertility record at the infertility centerAbility to access and use the internetHaving sexual intercourse with one’s spouseProviding informed consent to participate in the studyScoring below 28 on the Rosen Female Sexual Function Index (FSFI)Scoring between 98 and 167 on the FPI questionnaireDiagnosis of primary infertility no limit no limit Female (1) having systemic diseases based on the medical record; (2) having mental disorders (psychosis and use of psychiatric medications based on the medical record); (3) use of alcohol, illicit drugs, psychotropic substances, or libido-enhancing medications; (4) severe marital conflict based on self-report; and (5) participating in other psychological interventions. N97 Female infertility Behavior Behavior Intervention group: counseling based on the Empathy, Intimacy, and Sexual Satisfaction (EIS) model. Women in the counseling group based on the Empathy, Intimacy, and Sexual Satisfaction (EIS) model will receive 8 consecutive online sessions, held once a week for 90 minutes by the second researcher, a senior midwifery counseling student who has completed the sexual disorders course and obtained the required certificate, under the supervision of the first researcher, the supervisor (a reproductive health specialist and clinical psychologist) and the third researcher, the consultant professor (a reproductive health specialist), in the Skyroom platform.The sessions will be delivered in the form of educational videos, PowerPoint presentations, lectures, and question-and-answer sessions. At the beginning of each session, a summary of the previous session will be reviewed, and the assignments from the previous session will be evaluated by the first and second researchers to assess progress in each session.The women will be asked to participate in the counseling discussions and raise their questions. The second researcher will also ask questions related to the session topics to encourage greater participation. To facilitate learning, the relevant educational video will also be shown. At the end of each session, a summary of the main points will be presented, participants’ questions will be answered, and the women will be asked to complete their homework assignments before the next session. Control group: counseling based on the Good Enough Sex (GES) model. Women in the counseling group based on the Good Enough Sex (GES) model will receive 8 consecutive online sessions, held once a week for 90 minutes by the second researcher, a senior midwifery counseling student who has completed the sexual disorders course and obtained the required certificate, under the supervision of the first researcher, the supervisor (a reproductive health specialist and clinical psychologist), and the third researcher, the consultant professor (a reproductive health specialist), in the Skyroom platform.The sessions will be delivered in the form of educational videos, PowerPoint presentations, lectures, and question-and-answer sessions. At the beginning of each session, a summary of the previous session will be reviewed, and the assignments from the previous session will be evaluated by the first and second researchers to assess progress in each session.The women will be asked to participate in the counseling discussions and raise their questions. The second researcher will also ask questions related to the session topics to encourage greater participation. To facilitate learning, the relevant educational video will also be shown. At the end of each session, a summary of the main points will be presented, participants’ questions will be answered, and the women will be asked to complete their homework assignments before the next session. Sexual function. Timepoint: At baseline, week 8 (end of intervention), week 12 (follow-up). Method of measurement: Female Sexual Function Index (FSFI) questionnaire. Infertility-Related Stress. Timepoint: At baseline, week 8 (end of intervention), week 12 (follow-up). Method of measurement: FPI- Newton Infertility Stress Questionnaire. Shahid Sadoughi University of Medical Sciences, Yazd, Iran Approved 2026-07-21 Ethics Committee of the Yazd Reproductive Sciences Institute Reproductive Sciences Institute, Bouali St., Safaieh, Yazd, Iran yazd Yazd Iran (Islamic Republic of)