InfertilityNCT04791683
Sexual Counseling According to the PLISSIT Model in Primary Infertile Couples
A study testing sexaul counseling in people with Infertility and Sexuality, run by Istanbul University - Cerrahpasa at 1 site in Turkey (Türkiye).
Trial summary
This study was planned to determine the effect of sexual counseling given to primary infertile couples in line with the PLISSIT model on sexual function and sexual satisfaction. Read more about this study
- Who is it for?
- Ages 18 to 45 years
- Conditions the study is for
- Infertility, Sexuality, Sexual Dysfunction
- What is being tested?
- sexaul counseling
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 19 Aug 2019to 30 Sep 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Sexual dysfunction in infertile men and women (FSFI = 26.55 points and below, ---ASEX≥11 points and above)
- Having been diagnosed with infertility at least a year ago
- Being in the diagnostic test phase
- On the day of vaccination
- After IVF / ICSI-Embryo Transfer
- 18-45 years of age
- Being literate,
Who cannot join
- Having a chronic disease other than infertility
- With a psychiatric illness
- Have any chronic disease
- Couples with Secondary Infertility
- IVF / ICSI-OPU (Egg pick up)
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Ezgi ŞAHİN
Istanbul
Ezgi ŞAHİN, Msc, +905316961737, ezgishn90@gmail.com
İlkay GÜNGÖR SATILMIŞ, associate professor, +905356464768, ilkay1979@yahoo.com
About this study
Official title: The Effect of Sexual Counseling Given to Infertile Couples in Line With PLISSIT Model on Sexual Function and Sexual Satisfaction
This study was planned to determine the effect of sexual counseling given to primary infertile couples in line with the PLISSIT model on sexual function and sexual satisfaction.
Read the detailed description
The study will be conducted in the Infertility clinic of a medical faculty hospital. Couples receiving primary infertility treatment will be included in the study. It is planned to apply "Introductory Information Form, Female Sexual Function Index, Arizona Sexual Experiences Scale Male Form, Beck Depression Scale, New Sexual Satisfaction Scale and Infertility Stress Scale" to the experimental and control groups in the pre-initial evaluation. Within the scope of sexual counseling to be given to the couples in the experimental group in line with the PLISSIT Model; In order to increase the level of sexual function and sexual satisfaction, education of reproductive system anatomy and physiology, providing information about how the infertility process and treatment can affect sexual functions, determining the problems related to sexual health, trying to eliminate the misinformation and myths about sexuality, It is planned to include suggestions such as helping to cope well, alternative sexual intercourse positions according to the needs of the couples, body exploring exercise, sexual organs exploration exercise, masturbation exercise, kegel exercise.
The experimental group will be given an appointment for "sexual counseling" sessions held in 3 sessions at least 1 week apart. Each of these sessions will be completed in 60 minutes. Before the interviews, in line with the literature, "Sexual Counseling Booklet for Infertile Couples" will be prepared. In line with the scope of sexual counseling, the study is planned to be terminated by conducting 5 face-to-face interviews and 1 phone call with the experimental group. In the final evaluation, in order to determine the effects of sexual counseling on sexual health with the experimental group, the 'Introductory Information Form', Female Sexual Function Index, Male Form of Arizona Sexual Experiences Scale, New Sexual Satisfaction Scale and Infertility Stress Scale, at the appointment dates planned on the 3rd month after the first interview. '' The research will be terminated by filling in a face-to-face interview.
The couples in the control group will be interviewed in the second month after the first interview, and on the appointment dates scheduled for the 3rd month after the first interview, '' Introductory Information Form, Female Sexual Function Index, Arizona Sexual Experiences Scale Male Form, New Sexual Satisfaction Scale. and Infertility Stress Scale '' will be filled again with a face-to-face interview, and the research will be terminated.
- Conditions
- Infertility, Sexuality, Sexual Dysfunction, Nurse's Role, Infertility; Female, Infertility, Male
- Being tested
- sexaul counseling
- Medical subject headings
- Infertility, Sexuality, Sexual Dysfunction, Physiological, Infertility, Female, Infertility, Male
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
sexaul counselingOther
Sexual counseling includes interviews about sexual problems in couples who are in the process of infertility treatment and suggestions for solving these problems.
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | Infertile couples in the control group were selected by randomization, routine protocols in the clinic were applied |
| Experimental | Experimental | 1. st interview: Application of data collection tools
2. nd meeting: Sexual counseling (1 week after the first interview)
3. rd interview: Sexual counseling (1 week after the first session)
4. th meeting: Sexual counseling (1 week after the second session)
5. th interview: Telephone interview (2 months after the first assessment)
6. th interview: re-application of data collection tools, including the final evaluation Receives: Other: sexaul counseling |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Female Sexual Function Index
The levels of desire, arousal, lubrication, orgasm, satisfaction and sexual pain in women are evaluated in the first and final evaluation
Measured: The first assessment (ie first measurements) of sexual function levels is made on the first day of diagnostic tests for both groups of women attending the infertility clinic.
The Female Sexual Function Index
The levels of desire, arousal, lubrication, orgasm, satisfaction and sexual pain in women are evaluated in the first and final evaluation
Measured: The final assessment of sexual function levels (ie the last measurements) is made for women in both groups, on average 12 weeks after the initial assessment.
Arizona Sexual Experiences Scale Male Form
In the first evaluation and in the final evaluation, the sexual function level of men and the sexual problems that arise are evaluated.
Measured: The first assessment (ie first measurements) of sexual function levels is made on the first day of diagnostic tests for both groups of men attending the infertility clinic.
Arizona Sexual Experiences Scale Male Form
In the first evaluation and in the final evaluation, the sexual function level of men and the sexual problems that arise are evaluated.
Measured: The final assessment of sexual function levels (ie the last measurements) is made for men in both groups, on average 12 weeks after the initial assessment.
The New Sexual Satisfaction Scale
In the first and final evaluation, the self-centered sub-dimension, which is the first sub-dimension of the scale, measures the level of sexual satisfaction consisting mostly of personal experiences, while in the second sub-dimension, the co-partner / sexual activity-centered sub-dimension, the sexual behavior and reactions of the person's partner and also the diversity of sexual activity and / or the level of sexual satisfaction obtained from the frequency is evaluated.
Measured: The first assessment of sexual satisfaction levels (ie the first measurements) is made on the first day of diagnostic tests for both male and female groups admitted to the infertility clinic.
The New Sexual Satisfaction Scale
In the first and final evaluation, the self-centered sub-dimension, which is the first sub-dimension of the scale, measures the level of sexual satisfaction consisting mostly of personal experiences, while in the second sub-dimension, the co-partner / sexual activity-centered sub-dimension, the sexual behavior and reactions of the person's partner and also the diversity of sexual activity and / or the level of sexual satisfaction obtained from the frequency is evaluated.
Measured: The final assessment of sexual satisfaction levels (ie the last measurements) is made for men and women in both groups, on average, 12 weeks after the initial assessment.
Infertility Stress Scale
In the first and last evaluation, stress in the personal sphere, stress in the marital sphere and stress in the social sphere are measured using the Infertility Stress Scale (ISI).
Measured: The first assessment of infertility stress levels (ie the first measurements) is made on the first day of diagnostic tests for both male and female groups attending the infertility clinic.
Infertility Stress Scale
In the first and last evaluation, stress in the personal sphere, stress in the marital sphere and stress in the social sphere are measured using the Infertility Stress Scale (ISI).
Measured: The final assessment of infertility stress levels (ie final measurements) is made for men and women in both groups, on average 12 weeks after the initial assessment.
Beck Depression Inventory
In the first evaluation, various symptoms and severity of depression that may exist in individuals are evaluated.
Measured: The first assessment of depression levels (ie first measurements) is made on the first day of diagnostic tests for both male and female groups attending the infertility clinic.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2021
- Study start19 Aug 2019
- Primary completion20 Apr 2021 (estimated)
- Study completion30 Sep 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for InfertilityStudies of the same condition, open and under way.
- More trials run by Istanbul University - CerrahpasaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Parallel assignment Randomized controlled experimental study
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Istanbul University - Cerrahpasa
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ezgi SAHİN, Istanbul University - Cerrahpasa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04791683
- Sponsor's protocol ID
- 13022260-300-108795
- Status last verified
- Mar 2021
- First submitted
- 7 Mar 2021
- Last updated
- 17 Mar 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Benksim A, Elkhoudri N, Addi RA, Baali A, Cherkaoui M. Difference between Primary and Secondary Infertility in Morocco: Frequencies and Associated Factors. Int J Fertil Steril. 2018 Jul;12(2):142-146. doi: 10.22074/ijfs.2018.5188. Epub 2018 Mar 18.
PubMed 29707931Brassard A, Dupuy E, Bergeron S, Shaver PR. Attachment insecurities and women's sexual function and satisfaction: the mediating roles of sexual self-esteem, sexual anxiety, and sexual assertiveness. J Sex Res. 2015;52(1):110-9. doi: 10.1080/00224499.2013.838744. Epub 2013 Dec 18.
PubMed 24350570Czyzkowska A, Awruk K, Janowski K. Sexual Satisfaction and Sexual Reactivity in Infertile Women: The Contribution of The Dyadic Functioning and Clinical Variables. Int J Fertil Steril. 2016 Jan-Mar;9(4):465-76. doi: 10.22074/ijfs.2015.4604. Epub 2015 Dec 23.
PubMed 26985333Farnam F, Janghorbani M, Raisi F, Merghati-Khoei E. Compare the effectiveness of PLISSIT and sexual health models on women's sexual problems in Tehran, Iran: a randomized controlled trial. J Sex Med. 2014 Nov;11(11):2679-89. doi: 10.1111/jsm.12659. Epub 2014 Aug 5.
PubMed 25091932Ferraresi SR, Lara LA, de Sa MF, Reis RM, Rosa e Silva AC. Current research on how infertility affects the sexuality of men and women. Recent Pat Endocr Metab Immune Drug Discov. 2013 Sep;7(3):198-202. doi: 10.2174/18722148113079990009.
PubMed 23829396Khakbazan Z, Daneshfar F, Behboodi-Moghadam Z, Nabavi SM, Ghasemzadeh S, Mehran A. The effectiveness of the Permission, Limited Information, Specific suggestions, Intensive Therapy (PLISSIT) model based sexual counseling on the sexual function of women with Multiple Sclerosis who are sexually active. Mult Scler Relat Disord. 2016 Jul;8:113-9. doi: 10.1016/j.msard.2016.05.007. Epub 2016 May 24.
PubMed 27456885
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Sexual Counseling Given to Infertile Couples in Line With PLISSIT Model on Sexual Function and Sexual Satisfaction
- ClinicalTrials.gov ID
- NCT04791683
- Acronym / sponsor ID
- 13022260-300-108795
- Conditions
- Infertility, Sexuality, Sexual Dysfunction, Nurse's Role, Infertility; Female, Infertility, Male
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Istanbul University - CerrahpasaUniversity, hospital or other
- Study start
- 19 Aug 2019 (actual)
- Primary completion
- 20 Apr 2021 (estimated)
- Study completion
- 30 Sep 2021 (estimated)
- First posted
- 10 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study was planned to determine the effect of sexual counseling given to primary infertile couples in line with the PLISSIT model on sexual function and sexual satisfaction.
Detailed description
The study will be conducted in the Infertility clinic of a medical faculty hospital. Couples receiving primary infertility treatment will be included in the study. It is planned to apply "Introductory Information Form, Female Sexual Function Index, Arizona Sexual Experiences Scale Male Form, Beck Depression Scale, New Sexual Satisfaction Scale and Infertility Stress Scale" to the experimental and control groups in the pre-initial evaluation. Within the scope of sexual counseling to be given to the couples in the experimental group in line with the PLISSIT Model; In order to increase the level of sexual function and sexual satisfaction, education of reproductive system anatomy and physiology, providing information about how the infertility process and treatment can affect sexual functions, determining the problems related to sexual health, trying to eliminate the misinformation and myths about sexuality, It is planned to include suggestions such as helping to cope well, alternative sexual intercourse positions according to the needs of the couples, body exploring exercise, sexual organs exploration exercise, masturbation exercise, kegel exercise.
The experimental group will be given an appointment for "sexual counseling" sessions held in 3 sessions at least 1 week apart. Each of these sessions will be completed in 60 minutes. Before the interviews, in line with the literature, "Sexual Counseling Booklet for Infertile Couples" will be prepared. In line with the scope of sexual counseling, the study is planned to be terminated by conducting 5 face-to-face interviews and 1 phone call with the experimental group. In the final evaluation, in order to determine the effects of sexual counseling on sexual health with the experimental group, the 'Introductory Information Form', Female Sexual Function Index, Male Form of Arizona Sexual Experiences Scale, New Sexual Satisfaction Scale and Infertility Stress Scale, at the appointment dates planned on the 3rd month after the first interview. '' The research will be terminated by filling in a face-to-face interview.
The couples in the control group will be interviewed in the second month after the first interview, and on the appointment dates scheduled for the 3rd month after the first interview, '' Introductory Information Form, Female Sexual Function Index, Arizona Sexual Experiences Scale Male Form, New Sexual Satisfaction Scale. and Infertility Stress Scale '' will be filled again with a face-to-face interview, and the research will be terminated.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Parallel assignment Randomized controlled experimental study
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –Infertile couples in the control group were selected by randomization, routine protocols in the clinic were applied |
| Experimental | Experimental | Other: sexaul counseling1. st interview: Application of data collection tools 2. nd meeting: Sexual counseling (1 week after the first interview) 3. rd interview: Sexual counseling (1 week after the first session) 4. th meeting: Sexual counseling (1 week after the second session) 5. th interview: Telephone interview (2 months after the first assessment) 6. th interview: re-application of data collection tools, including the final evaluation |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Sexual dysfunction in infertile men and women (FSFI = 26.55 points and below, ---ASEX≥11 points and above)
- Having been diagnosed with infertility at least a year ago
- Being in the diagnostic test phase
- On the day of vaccination
- After IVF / ICSI-Embryo Transfer
Key exclusion criteria (5 listed)
- Having a chronic disease other than infertility
- With a psychiatric illness
- Have any chronic disease
- Couples with Secondary Infertility
- IVF / ICSI-OPU (Egg pick up)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| sexaul counselingSexual counseling includes interviews about sexual problems in couples who are in the process of infertility treatment and suggestions for solving these problems. | Other | Experimental |
Primary outcome
The Female Sexual Function Index
Time frame: The first assessment (ie first measurements) of sexual function levels is made on the first day of diagnostic tests for both groups of women attending the infertility clinic.
The levels of desire, arousal, lubrication, orgasm, satisfaction and sexual pain in women are evaluated in the first and final evaluation
The Female Sexual Function Index
Time frame: The final assessment of sexual function levels (ie the last measurements) is made for women in both groups, on average 12 weeks after the initial assessment.
The levels of desire, arousal, lubrication, orgasm, satisfaction and sexual pain in women are evaluated in the first and final evaluation
Arizona Sexual Experiences Scale Male Form
Time frame: The first assessment (ie first measurements) of sexual function levels is made on the first day of diagnostic tests for both groups of men attending the infertility clinic.
In the first evaluation and in the final evaluation, the sexual function level of men and the sexual problems that arise are evaluated.
Arizona Sexual Experiences Scale Male Form
Time frame: The final assessment of sexual function levels (ie the last measurements) is made for men in both groups, on average 12 weeks after the initial assessment.
In the first evaluation and in the final evaluation, the sexual function level of men and the sexual problems that arise are evaluated.
The New Sexual Satisfaction Scale
Time frame: The first assessment of sexual satisfaction levels (ie the first measurements) is made on the first day of diagnostic tests for both male and female groups admitted to the infertility clinic.
In the first and final evaluation, the self-centered sub-dimension, which is the first sub-dimension of the scale, measures the level of sexual satisfaction consisting mostly of personal experiences, while in the second sub-dimension, the co-partner / sexual activity-centered sub-dimension, the sexual behavior and reactions of the person's partner and also the diversity of sexual activity and / or the level of sexual satisfaction obtained from the frequency is evaluated.
The New Sexual Satisfaction Scale
Time frame: The final assessment of sexual satisfaction levels (ie the last measurements) is made for men and women in both groups, on average, 12 weeks after the initial assessment.
In the first and final evaluation, the self-centered sub-dimension, which is the first sub-dimension of the scale, measures the level of sexual satisfaction consisting mostly of personal experiences, while in the second sub-dimension, the co-partner / sexual activity-centered sub-dimension, the sexual behavior and reactions of the person's partner and also the diversity of sexual activity and / or the level of sexual satisfaction obtained from the frequency is evaluated.
Infertility Stress Scale
Time frame: The first assessment of infertility stress levels (ie the first measurements) is made on the first day of diagnostic tests for both male and female groups attending the infertility clinic.
In the first and last evaluation, stress in the personal sphere, stress in the marital sphere and stress in the social sphere are measured using the Infertility Stress Scale (ISI).
Infertility Stress Scale
Time frame: The final assessment of infertility stress levels (ie final measurements) is made for men and women in both groups, on average 12 weeks after the initial assessment.
In the first and last evaluation, stress in the personal sphere, stress in the marital sphere and stress in the social sphere are measured using the Infertility Stress Scale (ISI).
Beck Depression Inventory
Time frame: The first assessment of depression levels (ie first measurements) is made on the first day of diagnostic tests for both male and female groups attending the infertility clinic.
In the first evaluation, various symptoms and severity of depression that may exist in individuals are evaluated.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Mar 2021.
- Background: PubMed 29707931Benksim A, Elkhoudri N, Addi RA, Baali A, Cherkaoui M. Difference between Primary and Secondary Infertility in Morocco: Frequencies and Associated Factors. Int J Fertil Steril. 2018 Jul;12(2):142-146. doi: 10.22074/ijfs.2018.5188. Epub 2018 Mar 18.
- Background: PubMed 24350570Brassard A, Dupuy E, Bergeron S, Shaver PR. Attachment insecurities and women's sexual function and satisfaction: the mediating roles of sexual self-esteem, sexual anxiety, and sexual assertiveness. J Sex Res. 2015;52(1):110-9. doi: 10.1080/00224499.2013.838744. Epub 2013 Dec 18.
- Background: PubMed 26985333Czyzkowska A, Awruk K, Janowski K. Sexual Satisfaction and Sexual Reactivity in Infertile Women: The Contribution of The Dyadic Functioning and Clinical Variables. Int J Fertil Steril. 2016 Jan-Mar;9(4):465-76. doi: 10.22074/ijfs.2015.4604. Epub 2015 Dec 23.
- Background: PubMed 25091932Farnam F, Janghorbani M, Raisi F, Merghati-Khoei E. Compare the effectiveness of PLISSIT and sexual health models on women's sexual problems in Tehran, Iran: a randomized controlled trial. J Sex Med. 2014 Nov;11(11):2679-89. doi: 10.1111/jsm.12659. Epub 2014 Aug 5.
- Background: PubMed 23829396Ferraresi SR, Lara LA, de Sa MF, Reis RM, Rosa e Silva AC. Current research on how infertility affects the sexuality of men and women. Recent Pat Endocr Metab Immune Drug Discov. 2013 Sep;7(3):198-202. doi: 10.2174/18722148113079990009.
- Background: PubMed 27456885Khakbazan Z, Daneshfar F, Behboodi-Moghadam Z, Nabavi SM, Ghasemzadeh S, Mehran A. The effectiveness of the Permission, Limited Information, Specific suggestions, Intensive Therapy (PLISSIT) model based sexual counseling on the sexual function of women with Multiple Sclerosis who are sexually active. Mult Scler Relat Disord. 2016 Jul;8:113-9. doi: 10.1016/j.msard.2016.05.007. Epub 2016 May 24.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing sexaul counseling in people with Infertility and Sexuality, run by Istanbul University - Cerrahpasa at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 17 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ezgi ŞAHİN, Msc (+905316961737, ezgishn90@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Female Sexual Function Index (time frame: The first assessment (ie first measurements) of sexual function levels is made on the first day of diagnostic tests for both groups of women attending the infertility clinic.). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04791683, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Mar 2021.