InfertilityNCT04703725
The Effect of IVF Counseling on Psychosocial Well-Being
A study testing Psychosocial Care in people with Infertility and Psychological Distress, run by Istanbul University - Cerrahpasa at 1 site in Turkey (Türkiye).
Trial summary
In this study, İt was aimed to determination of the effect of counseling given in accordance with the Roy Adaptation Model in women in the in vitro fertilization (IVF) process on emotional capacity and well-being. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women only
- Conditions the study is for
- Infertility, Psychological Distress, Infertility, Female
- What is being tested?
- Psychosocial Care
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 85 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 4 Feb 2020to 16 Mar 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 40 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- IVF treatmant
- Women
- Women aged18-40 years
- Sign the informed consent form
Who cannot join
- Having a psychiatric diagnosis /
- Having a situation that prevents communication (language, etc.)
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
İstanbul University-Cerrrahpaşa
Istanbul, 34381
About this study
Official title: The Effect of the Counseling on Women in In Vitro Fertilization (IVF) Process on Emotional Capacity and Well-Being
In this study, İt was aimed to determination of the effect of counseling given in accordance with the Roy Adaptation Model in women in the in vitro fertilization (IVF) process on emotional capacity and well-being.
Read the detailed description
The study will be conducted in the Infertility clinic of a medical school hospital. The study included women receiving IVF treatment. In the pre-initial evaluation, "Introductory Information Form, Screening on distress in fertility treatment (SCREENIVF), Infertility Stress, Life Quality Scale for Persons with Fertility Problems(FertiQol), Subjective Units of Distress Scale-SUD application is planned. A "Consultancy Program" will be applied to the experimental group in the form of two modules in addition to drug applications, egg pick up and embryo transfer before, during and after clinical routine health care. The first module of the counseling program is the definition of infertility, the treatment process, its effects on the life process and coping methods. The second module includes the application of breath awareness and Emotional Freedom Technique (EFT) within the scope of coping methods with infertility stress. Emotional Freedom Technique-EFT is an energy psychotherapy based on the principle that each limiting thought, disturbing emotion and memory of an individual disrupts the energy flow in the body and creates congestion. This technique, the stimulation on the meridian system by focusing on the thought, disturbing emotion or memory that prevents the individual (often by touching) regulates the energy flow and provides the individual to relax. With breath awareness, beneficial results can be obtained, such as physical, sensory and mental control, life-facilitating techniques, individual and social awareness, re-existence and raising the level of consciousness. Within the scope of the counseling program, a total of seven follow-ups will be made, five-to-one, via two phone calls. On the day of follicle development (2nd Follow-up), Egg Pick up Procedure (4th Follow-up) and Embryo transfer (5th Follow-up), the patient will be given breathing exercises and EFT and Subjective Units of Distress Scale will be scored. The control group will continue clinical routine health care and will be followed up on the first day of IVF treatment (1st follow-up) and on the seventh day of embryo transfer (2nd follow-up). For ethical reasons, a consultancy program will be applied to the control group after the second follow-up. Data collection tools will be applied again to both groups in the final evaluation.
- Conditions
- Infertility, Psychological Distress, Infertility, Female, Depression, Anxiety, Nurse's Role
- Being tested
- Psychosocial Care
- Medical subject headings
- Infertility, Infertility, Female, Depression, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Psychosocial CareBehavioural
Also called First Follow-Up, Second Follow-up, Third Follow-up, Fourth Follow-up
- First Follow-Up: One of the implementation of the module
- Second Follow-up: Implementation of the second module; Breathing Exercises and EFT
- Third Follow-up: Emotional preparation about egg pick up process, individual application of coping methods
- Fourth Follow-up: Implementation of the second module; Briefing about Breathing Exercises and EFT embryo transfer process
- Fifth Follow-up: Implementation of the second module; Breathing Exercises and EFT
- Sixth Follow-up: Individual application of coping methods until the learning process of pregnancy test result
- Seventh Follow-up: Providing information about the first periods of pregnancy after treatment resulting in pregnancy and providing information about the psychosocial problems that may be encountered. Identifying psychosocial problems that may be encountered after unsuccessful treatment and individual application of coping methods to help cope.
| Study group | Role | What they receive |
|---|---|---|
| Experimental Group | Experimental | Infertile women recruited to the experimental group by randomization will be given a counseling program including psychosocial care in addition to routine (drug explanation during the treatment, preparation before the egg pick up and embryo transfer and post operative care). IVF treatment Receives: Behavioral: Psychosocial Care |
| Control Group | No intervention | Routine (drug explanation during the treatment, preparation before the egg pick up and embryo transfer and post operative care) IVF treatment will be applied to infertile women who are randomized to the control group. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Screening on distress in fertility treatment
Anxiety (state anxiety, trait anxiety), Depression, Social support, Cognitions regarding fertility problems are measured using screening on distress in fertility treatment (SCREENIVF).
Measured: Measurement for each group in the beginning of the IVF treatment
Screening on distress in fertility treatment
Anxiety (state anxiety, trait anxiety), Depression, Social support, Cognitions regarding fertility problems are measured using screening on distress in fertility treatment (SCREENIVF).
Measured: Measurement for each group seven days after embryo transfer
Infertility Stress
Personal stress, marital stress, and social stress are measured using The Fertility Problem Stress Inventory
Measured: Measurement for each group in the beginning of the IVF treatment
Infertility Stress
Personal stress, marital stress, and social stress are measured using The Fertility Problem Stress Inventory
Measured: Measurement for each group seven days after embryo transfer
Life Quality Scale for Persons with Fertility Problems
Life Quality Scale for Persons with Fertility Problems (FertiQol) is used to measure the effect of quality and accessibility of treatment on quality of life.
Measured: Measurement for each group in the beginning of the IVF treatment
Life Quality Scale for Persons with Fertility Problems
Life Quality Scale for Persons with Fertility Problems (FertiQol) is used to measure the effect of quality and accessibility of treatment on quality of life.
Measured: Measurement for each group seven days after embryo transfer
Subjective Units of Distress Scale
Applied to the experimental group. Before starting the application in energy therapies, the problem is evaluated with the severity of the discomfort. It is the subjective evaluation of the discomfort felt by the individual.
Measured: The day follicle development is followed
Subjective Units of Distress Scale
Applied to the experimental group.Before starting the application in energy therapies, the problem is evaluated with the severity of the discomfort. It is the subjective evaluation of the discomfort felt by the individual.
Measured: Egg pick up procedure day
Subjective Units of Distress Scale
Applied to the experimental group.Before starting the application in energy therapies, the problem is evaluated with the severity of the discomfort. It is the subjective evaluation of the discomfort felt by the individual.
Measured: Embryo transfer day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2021
- Study start4 Feb 2020
- Primary completion16 Mar 2021
- Study completion16 Mar 2021
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
- Randomized Controlled Experimental Design
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 85 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istanbul University - Cerrahpasa
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ergul Aslan, Istanbul University - Cerrahpasa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04703725
- Sponsor's protocol ID
- 9199
- Status last verified
- Apr 2022
- First submitted
- 6 Jan 2021
- Last updated
- 15 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The research article will be shared after publication
Publications
Van den Broeck U, Emery M, Wischmann T, Thorn P. Counselling in infertility: individual, couple and group interventions. Patient Educ Couns. 2010 Dec;81(3):422-8. doi: 10.1016/j.pec.2010.10.009. Epub 2010 Nov 13.
PubMed 21075589Gameiro S, Boivin J, Dancet E, de Klerk C, Emery M, Lewis-Jones C, Thorn P, Van den Broeck U, Venetis C, Verhaak CM, Wischmann T, Vermeulen N. ESHRE guideline: routine psychosocial care in infertility and medically assisted reproduction-a guide for fertility staff. Hum Reprod. 2015 Nov;30(11):2476-85. doi: 10.1093/humrep/dev177. Epub 2015 Sep 7.
PubMed 26345684Ockhuijsen HDL, van Smeden M, van den Hoogen A, Boivin J. Validation study of the SCREENIVF: an instrument to screen women or men on risk for emotional maladjustment before the start of a fertility treatment. Fertil Steril. 2017 Jun;107(6):1370-1379.e5. doi: 10.1016/j.fertnstert.2017.04.008. Epub 2017 May 10.
PubMed 28501369Homan GF, Davies M, Norman R. The impact of lifestyle factors on reproductive performance in the general population and those undergoing infertility treatment: a review. Hum Reprod Update. 2007 May-Jun;13(3):209-23. doi: 10.1093/humupd/dml056. Epub 2007 Jan 5.
PubMed 17208948Verhaak CM, Smeenk JM, van Minnen A, Kremer JA, Kraaimaat FW. A longitudinal, prospective study on emotional adjustment before, during and after consecutive fertility treatment cycles. Hum Reprod. 2005 Aug;20(8):2253-60. doi: 10.1093/humrep/dei015. Epub 2005 Apr 7.
PubMed 15817584Frederiksen Y, Farver-Vestergaard I, Skovgard NG, Ingerslev HJ, Zachariae R. Efficacy of psychosocial interventions for psychological and pregnancy outcomes in infertile women and men: a systematic review and meta-analysis. BMJ Open. 2015 Jan 28;5(1):e006592. doi: 10.1136/bmjopen-2014-006592.
PubMed 25631310
Study at a glance
From the registry record, last updated by the sponsor on 15 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of the Counseling on Women in In Vitro Fertilization (IVF) Process on Emotional Capacity and Well-Being
- ClinicalTrials.gov ID
- NCT04703725
- Acronym / sponsor ID
- 9199
- Conditions
- Infertility, Psychological Distress, Infertility, Female, Depression, Anxiety, Nurse's Role
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 85 participants (actual)
- Lead sponsor
- Istanbul University - CerrahpasaUniversity, hospital or other
- Study start
- 4 Feb 2020 (actual)
- Primary completion
- 16 Mar 2021 (actual)
- Study completion
- 16 Mar 2021 (actual)
- First posted
- 11 Jan 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.
In this study, İt was aimed to determination of the effect of counseling given in accordance with the Roy Adaptation Model in women in the in vitro fertilization (IVF) process on emotional capacity and well-being.
Detailed description
The study will be conducted in the Infertility clinic of a medical school hospital. The study included women receiving IVF treatment. In the pre-initial evaluation, "Introductory Information Form, Screening on distress in fertility treatment (SCREENIVF), Infertility Stress, Life Quality Scale for Persons with Fertility Problems(FertiQol), Subjective Units of Distress Scale-SUD application is planned. A "Consultancy Program" will be applied to the experimental group in the form of two modules in addition to drug applications, egg pick up and embryo transfer before, during and after clinical routine health care. The first module of the counseling program is the definition of infertility, the treatment process, its effects on the life process and coping methods. The second module includes the application of breath awareness and Emotional Freedom Technique (EFT) within the scope of coping methods with infertility stress. Emotional Freedom Technique-EFT is an energy psychotherapy based on the principle that each limiting thought, disturbing emotion and memory of an individual disrupts the energy flow in the body and creates congestion. This technique, the stimulation on the meridian system by focusing on the thought, disturbing emotion or memory that prevents the individual (often by touching) regulates the energy flow and provides the individual to relax. With breath awareness, beneficial results can be obtained, such as physical, sensory and mental control, life-facilitating techniques, individual and social awareness, re-existence and raising the level of consciousness. Within the scope of the counseling program, a total of seven follow-ups will be made, five-to-one, via two phone calls. On the day of follicle development (2nd Follow-up), Egg Pick up Procedure (4th Follow-up) and Embryo transfer (5th Follow-up), the patient will be given breathing exercises and EFT and Subjective Units of Distress Scale will be scored. The control group will continue clinical routine health care and will be followed up on the first day of IVF treatment (1st follow-up) and on the seventh day of embryo transfer (2nd follow-up). For ethical reasons, a consultancy program will be applied to the control group after the second follow-up. Data collection tools will be applied again to both groups in the final evaluation.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Randomized Controlled Experimental Design
| Arm | Type | Receives |
|---|---|---|
| Experimental Group | Experimental | Behavioral: Psychosocial CareInfertile women recruited to the experimental group by randomization will be given a counseling program including psychosocial care in addition to routine (drug explanation during the treatment, preparation before the egg pick up and embryo transfer and post operative care). IVF treatment |
| Control Group | No intervention | –Routine (drug explanation during the treatment, preparation before the egg pick up and embryo transfer and post operative care) IVF treatment will be applied to infertile women who are randomized to the control group. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- IVF treatmant
- Women
- Women aged18-40 years
- Sign the informed consent form
Key exclusion criteria (2 listed)
- Having a psychiatric diagnosis /
- Having a situation that prevents communication (language, etc.)
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 |
|---|---|---|
| Psychosocial CareAlso: First Follow-Up, Second Follow-up, Third Follow-up, Fourth Follow-up1. First Follow-Up: One of the implementation of the module 2. Second Follow-up: Implementation of the second module; Breathing Exercises and EFT 3. Third Follow-up: Emotional preparation about egg pick up process, individual application of coping methods 4. Fourth Follow-up: Implementation of the second module; Briefing about Breathing Exercises and EFT embryo transfer process 5. Fifth Follow-up: Implementation of the second module; Breathing Exercises and EFT 6. Sixth Follow-up: Individual application of coping methods until the learning process of pregnancy test result 7. Seventh Follow-up: Providing information about the first periods of pregnancy after treatment resulting in pregnancy and providing information about the psychosocial problems that may be encountered. Identifying psychosocial problems that may be encountered after unsuccessful treatment and individual application of coping methods to help cope. | Behavioural | Experimental Group |
Primary outcome
Screening on distress in fertility treatment
Time frame: Measurement for each group in the beginning of the IVF treatment
Anxiety (state anxiety, trait anxiety), Depression, Social support, Cognitions regarding fertility problems are measured using screening on distress in fertility treatment (SCREENIVF).
Screening on distress in fertility treatment
Time frame: Measurement for each group seven days after embryo transfer
Anxiety (state anxiety, trait anxiety), Depression, Social support, Cognitions regarding fertility problems are measured using screening on distress in fertility treatment (SCREENIVF).
Infertility Stress
Time frame: Measurement for each group in the beginning of the IVF treatment
Personal stress, marital stress, and social stress are measured using The Fertility Problem Stress Inventory
Infertility Stress
Time frame: Measurement for each group seven days after embryo transfer
Personal stress, marital stress, and social stress are measured using The Fertility Problem Stress Inventory
Life Quality Scale for Persons with Fertility Problems
Time frame: Measurement for each group in the beginning of the IVF treatment
Life Quality Scale for Persons with Fertility Problems (FertiQol) is used to measure the effect of quality and accessibility of treatment on quality of life.
Life Quality Scale for Persons with Fertility Problems
Time frame: Measurement for each group seven days after embryo transfer
Life Quality Scale for Persons with Fertility Problems (FertiQol) is used to measure the effect of quality and accessibility of treatment on quality of life.
Subjective Units of Distress Scale
Time frame: The day follicle development is followed
Applied to the experimental group. Before starting the application in energy therapies, the problem is evaluated with the severity of the discomfort. It is the subjective evaluation of the discomfort felt by the individual.
Subjective Units of Distress Scale
Time frame: Egg pick up procedure day
Applied to the experimental group.Before starting the application in energy therapies, the problem is evaluated with the severity of the discomfort. It is the subjective evaluation of the discomfort felt by the individual.
Subjective Units of Distress Scale
Time frame: Embryo transfer day
Applied to the experimental group.Before starting the application in energy therapies, the problem is evaluated with the severity of the discomfort. It is the subjective evaluation of the discomfort felt by the individual.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Apr 2022.
- Background: PubMed 21075589Van den Broeck U, Emery M, Wischmann T, Thorn P. Counselling in infertility: individual, couple and group interventions. Patient Educ Couns. 2010 Dec;81(3):422-8. doi: 10.1016/j.pec.2010.10.009. Epub 2010 Nov 13.
- Background: PubMed 26345684Gameiro S, Boivin J, Dancet E, de Klerk C, Emery M, Lewis-Jones C, Thorn P, Van den Broeck U, Venetis C, Verhaak CM, Wischmann T, Vermeulen N. ESHRE guideline: routine psychosocial care in infertility and medically assisted reproduction-a guide for fertility staff. Hum Reprod. 2015 Nov;30(11):2476-85. doi: 10.1093/humrep/dev177. Epub 2015 Sep 7.
- Background: PubMed 28501369Ockhuijsen HDL, van Smeden M, van den Hoogen A, Boivin J. Validation study of the SCREENIVF: an instrument to screen women or men on risk for emotional maladjustment before the start of a fertility treatment. Fertil Steril. 2017 Jun;107(6):1370-1379.e5. doi: 10.1016/j.fertnstert.2017.04.008. Epub 2017 May 10.
- Background: PubMed 17208948Homan GF, Davies M, Norman R. The impact of lifestyle factors on reproductive performance in the general population and those undergoing infertility treatment: a review. Hum Reprod Update. 2007 May-Jun;13(3):209-23. doi: 10.1093/humupd/dml056. Epub 2007 Jan 5.
- Background: PubMed 15817584Verhaak CM, Smeenk JM, van Minnen A, Kremer JA, Kraaimaat FW. A longitudinal, prospective study on emotional adjustment before, during and after consecutive fertility treatment cycles. Hum Reprod. 2005 Aug;20(8):2253-60. doi: 10.1093/humrep/dei015. Epub 2005 Apr 7.
- Background: PubMed 25631310Frederiksen Y, Farver-Vestergaard I, Skovgard NG, Ingerslev HJ, Zachariae R. Efficacy of psychosocial interventions for psychological and pregnancy outcomes in infertile women and men: a systematic review and meta-analysis. BMJ Open. 2015 Jan 28;5(1):e006592. doi: 10.1136/bmjopen-2014-006592.
- Individual participant dataSharing planned: No. The research article will be shared after publication
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Psychosocial Care in people with Infertility and Psychological Distress, 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 4 inclusion and 2 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: finished, as of the sponsor's last update on 15 Apr 2022. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Screening on distress in fertility treatment (time frame: Measurement for each group in the beginning of the IVF treatment). 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 NCT04703725, 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 15 Apr 2022.