Protocol summary
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Study aim
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determine and compare 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
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Design
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Design: Phase 2, RCT, parallel-group Sample: 68 patients Randomization: Permuted block (size 4) Concealment: Sequentially numbered, sealed envelopes
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Settings and conduct
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Setting: Yazd Reproductive Sciences Institute
Approvals: Ethics, University permit, IRCT registration/code
Sampling: Infertile women, inclusion criteria, written consent
Blinding: Single-blind (Data analyst only); participants/providers unblinded
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Participants/Inclusion and exclusion criteria
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Inclusion
Persian literacy & internet access
Primary infertility record
Active sexual relationship & consent
FSFI < 28 & FPI (98–167)
Exclusion
Systemic/psychiatric diseases or meds
Substance, alcohol, or sex-enhancer use
Severe marital conflict
Concurrent psychological interventions
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Intervention groups
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Intervention: 8 weekly 90-min online sessions (Skyroom) based on EIS & GES models.
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Main outcome variables
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sexual function
General information
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Reason for update
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“Sampling and patient enrollment have been delayed until administrative and security clearance at the center is finalized.”
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20260711070129N1
Registration date:
2026-07-30, 1405/05/08
Registration timing:
prospective
Last update:
2026-08-25, 1405/06/03
Update count:
1
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Registration date
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2026-07-30, 1405/05/08
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Registrant information
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Recruitment status
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recruiting
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Funding source
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Expected recruitment start date
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2026-09-23, 1405/07/01
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Expected recruitment end date
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2026-11-22, 1405/09/01
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Actual recruitment start date
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empty
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Actual recruitment end date
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empty
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Trial completion date
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empty
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Scientific title
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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
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Public title
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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
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Purpose
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Education/Guidance
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Inclusion/Exclusion criteria
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Inclusion criteria:
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
Exclusion criteria:
(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.
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Age
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No age limit
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Gender
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Female
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Phase
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N/A
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Groups that have been masked
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Sample size
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Target sample size:
68
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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Participants will be allocated to one of the two intervention groups using permuted block randomization with a block size of 4.
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Blinding (investigator's opinion)
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Single blinded
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Blinding description
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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.
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Placebo
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Not used
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Assignment
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Parallel
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Other design features
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Ethics committees
1
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Ethics committee
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Approval date
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2026-07-21, 1405/04/30
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Ethics committee reference number
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IR.SSU.RSI.REC.1405.011
Health conditions studied
1
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Description of health condition studied
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infertility
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ICD-10 code
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N97
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ICD-10 code description
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Female infertility
Primary outcomes
1
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Description
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sexual function
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Timepoint
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At baseline, week 8 (end of intervention), week 12 (follow-up)
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Method of measurement
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Female Sexual Function Index (FSFI) questionnaire
Secondary outcomes
1
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Description
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Infertility-Related Stress
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Timepoint
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At baseline, week 8 (end of intervention), week 12 (follow-up)
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Method of measurement
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FPI- Newton Infertility Stress Questionnaire
Intervention groups
1
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Description
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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.
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Category
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Behavior
2
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Description
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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.
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Category
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Behavior
1
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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No
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Title of funding source
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Shahid Sadoughi University of Medical Sciences, Yazd, Iran
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Proportion provided by this source
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100
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Public or private sector
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Public
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Academic
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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Yes - There is a plan to make this available
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Study Protocol
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Yes - There is a plan to make this available
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Statistical Analysis Plan
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Not applicable
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Informed Consent Form
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Yes - There is a plan to make this available
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Clinical Study Report
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Not applicable
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Analytic Code
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Not applicable
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Data Dictionary
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Undecided - It is not yet known if there will be a plan to make this available
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Title and more details about the data/document
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“The de-identified individual participant data will be available upon request.”
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When the data will become available and for how long
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after the publication of the results
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To whom data/document is available
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The data will be available to researchers at academic and scientific institutions, as well as those working in the industry, upon request
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Under which criteria data/document could be used
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"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."
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From where data/document is obtainable
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farajkhoda_t@yahoo.com
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What processes are involved for a request to access data/document
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one week after receiving the applicant’s email
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Comments
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