Fertilization in VitroNCT04755270
Virtual Reality-Supported Hypnofertility
A study testing VR Glasses in people with Fertilization in Vitro, run by Adiyaman University at 1 site in Turkey (Türkiye).
Trial summary
This research was conducted to determine the effect of virtual reality-supported hypnofertility on fertility preparedness, stress and coping with stress in women having in vitro fertilization. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Fertilization in Vitro
- What is being tested?
- VR Glasses
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 107 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 25 Feb 2019to 10 Jul 2020
- 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 Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Having IVF treatment
Who cannot join
- Having IVF treatment
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Virtual Reality-Supported Hypnofertility on Fertility Preparedness, Stress and Coping With Stress in Women Having In Vitro Fertilization
This research was conducted to determine the effect of virtual reality-supported hypnofertility on fertility preparedness, stress and coping with stress in women having in vitro fertilization. At the end of research It has been determined that initiatives based on the hypnofertility philosophy increase the level of preparedness to fertility, decrease the stress level and provide effective coping with stress in women who had IVF treatment.
Read the detailed description
It is estimated that the infertility affects 8-12% of all couples in reproductive age across the world. Various alternative methods were implemented for years for alleviating the stress which was felt by infertile women. The women in the process of infertility treatment make more efforts to be impregnated, their fertility preparedness is negatively affected and they need more psychosocial support. Upon the review of the relevant literature, it is discerned that there was a limited number of studies in which mind-body programs, namely, hypnofertility methods, were applied to the cases of infertility. In this research, in the first meeting with infertile women who would be assigned to the experimental group, the research objective was explained, and their consent to partake in the research was received in written and verbal format and pretest data were obtained. Later during in vitro fertilization, VR-supported hypnofertility treatment initiative which applied to the experimental group was implemented in four stages, namely, 'Stage 1 (the first folliculometry day)', 'Stage 2 (the second folliculometry day)', 'Stage 3 (oocyte retrieval stage)' and 'Stage 4 (embryo transfer stage)'. And posttest data were obtained at the end of last stage. Each process took 20 minutes on average. Meetings with infertile women who were assigned to the control group were held twice. In the first meeting, pretest data were collected. VR-supported hypnofertility treatment initiative was not applied to the control group, and posttest data were collected from the control group via the second meeting held on the same date as the fourth stage of treatment, namely, the day of embryo transfer. It is considered that the stress levels of women who are in the process of having IVF treatment will fall down and hence the fertility preparedness and the ability to cope with infertility stress will be positively affected by virtue of the effective use of hypnofertility method, which is still a new method in Turkey, by midwives and other health professionals.
- Conditions
- Fertilization in Vitro
- Being tested
- VR Glasses
- Keywords
- in vitro fertilization, hypnofertility, stress
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VR GlassesDevice
Also called techniques of hypnofertility
techniques of hypnofertility and VR glasses
| Study group | Role | What they receive |
|---|---|---|
| vr-supported hypnofertility | Experimental | Relaxation, visualization, imagination and affirmation and techniques based on the hypnofertility philosophy were applied to women in the experimental group in four stages Receives: Device: VR Glasses |
| Control | No intervention | Any initiative was not applied to the control group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fertility Preparedness Scale for Women Receiving Fertility Treatment
The scale is used for the assessment of the levels of stress experienced by infertile couples. As a Likert-type scale, it has three sub-scales in relation to personal, marital and social domains and contains a total of 14 items. 'Stress in personal domain' sub-scale contains six items, and the minimum and maximum scores to be obtained from it are successively 0 and 20 points. 'Stress in marital domain' sub-scale has four items, and the minimum and maximum scores to be obtained from it are successively 0 and 14 points. 'Stress in social domain' sub-scale is comprised of four items, and the minimum and maximum scores to be obtained from it are successively 0 and 12 points. A high score to be obtained from the sub-scale refers to the increase in the stress level.
Measured: Day 12
The Copenhagen Multi-centre Psychosocial Infertility Fertility Problem Stress
The scale is used for the assessment of the levels of stress experienced by infertile couples. As a Likert-type scale, it has three sub-scales in relation to personal, marital and social domains and contains a total of 14 items. 'Stress in personal domain' sub-scale contains six items, and the minimum and maximum scores to be obtained from it are successively 0 and 20 points. 'Stress in marital domain' sub-scale has four items, and the minimum and maximum scores to be obtained from it are successively 0 and 14 points. 'Stress in social domain' sub-scale is comprised of four items, and the minimum and maximum scores to be obtained from it are successively 0 and 12 points. A high score to be obtained from the sub-scale refers to the increase in the stress level.
Measured: Day 12
The Copenhagen Multi-centre Psychosocial Infertility Coping Strategy Scale
The scale contains 19 items and has four sub-scales. The minimum and maximum scores to be obtained from the sub-scale of 'active-avoidance' coping method which is comprised of four items are successively 4 and 16 points. The sub-scale of 'active-confronting' coping method contains seven items. The minimum and maximum scores to be obtained from this sub-scale are successively 7 and 26 points. The minimum and maximum scores to be obtained from the sub-scale of 'passive-avoidance' coping method which is comprised of three items are successively 3 and 12 points. The sub-scale of 'meaning-based' coping method contains five items. The minimum and maximum scores to be obtained from this sub-scale are successively 5 and 20 points. A higher score to be obtained from the subscale means that the method is used more when coping with with stress.
Measured: Day 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Feb 2021
- Study start25 Feb 2019
- Primary completion1 Jun 2020
- Study completion10 Jul 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Fertilization in VitroStudies of the same condition, open and under way.
- 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
- This research was conducted with the randomized control group pretest-posttest trial model.
- Masking
- None (open label)
- Enrolment
- 107 participants (actual)
Sponsor and investigators
- Lead sponsor
- Adiyaman University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Çiğdem Erdemoğlu, Adiyaman University
- Investigators
- Yeşim Aksoy Derya, Phd, Study director, Inonu University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04755270
- Sponsor's protocol ID
- AdıyamanU
- Status last verified
- Feb 2021
- First submitted
- 24 Jan 2021
- Last updated
- 16 Feb 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There is no plan to make individual participant data (IPD) available to other researchers. Because the institution where the research was conducted does not allow this.
Publications
Erdemoglu C, Aksoy Derya Y. The effect of hypnofertility on fertility preparedness, stress, and coping with stress in women having in vitro fertilization: A randomized controlled trial. J Reprod Infant Psychol. 2024 Jul;42(4):569-580. doi: 10.1080/02646838.2022.2156488. Epub 2022 Dec 13.
PubMed 36513620
Study at a glance
From the registry record, last updated by the sponsor on 16 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Virtual Reality-Supported Hypnofertility on Fertility Preparedness, Stress and Coping With Stress in Women Having In Vitro Fertilization
- ClinicalTrials.gov ID
- NCT04755270
- Acronym / sponsor ID
- AdıyamanU
- Conditions
- Fertilization in Vitro
- Keywords
- in vitro fertilization, hypnofertility, stress
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 107 participants (actual)
- Lead sponsor
- Adiyaman UniversityUniversity, hospital or other
- Study start
- 25 Feb 2019 (actual)
- Primary completion
- 1 Jun 2020 (actual)
- Study completion
- 10 Jul 2020 (actual)
- First posted
- 16 Feb 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 research was conducted to determine the effect of virtual reality-supported hypnofertility on fertility preparedness, stress and coping with stress in women having in vitro fertilization. At the end of research It has been determined that initiatives based on the hypnofertility philosophy increase the level of preparedness to fertility, decrease the stress level and provide effective coping with stress in women who had IVF treatment.
Detailed description
It is estimated that the infertility affects 8-12% of all couples in reproductive age across the world. Various alternative methods were implemented for years for alleviating the stress which was felt by infertile women. The women in the process of infertility treatment make more efforts to be impregnated, their fertility preparedness is negatively affected and they need more psychosocial support. Upon the review of the relevant literature, it is discerned that there was a limited number of studies in which mind-body programs, namely, hypnofertility methods, were applied to the cases of infertility. In this research, in the first meeting with infertile women who would be assigned to the experimental group, the research objective was explained, and their consent to partake in the research was received in written and verbal format and pretest data were obtained. Later during in vitro fertilization, VR-supported hypnofertility treatment initiative which applied to the experimental group was implemented in four stages, namely, 'Stage 1 (the first folliculometry day)', 'Stage 2 (the second folliculometry day)', 'Stage 3 (oocyte retrieval stage)' and 'Stage 4 (embryo transfer stage)'. And posttest data were obtained at the end of last stage. Each process took 20 minutes on average. Meetings with infertile women who were assigned to the control group were held twice. In the first meeting, pretest data were collected. VR-supported hypnofertility treatment initiative was not applied to the control group, and posttest data were collected from the control group via the second meeting held on the same date as the fourth stage of treatment, namely, the day of embryo transfer. It is considered that the stress levels of women who are in the process of having IVF treatment will fall down and hence the fertility preparedness and the ability to cope with infertility stress will be positively affected by virtue of the effective use of hypnofertility method, which is still a new method in Turkey, by midwives and other health professionals.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This research was conducted with the randomized control group pretest-posttest trial model.
| Arm | Type | Receives |
|---|---|---|
| vr-supported hypnofertility | Experimental | Device: VR GlassesRelaxation, visualization, imagination and affirmation and techniques based on the hypnofertility philosophy were applied to women in the experimental group in four stages |
| Control | No intervention | –Any initiative was not applied to the control group |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Having IVF treatment
Key exclusion criteria (1 listed)
- Having IVF treatment
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 |
|---|---|---|
| VR GlassesAlso: techniques of hypnofertilitytechniques of hypnofertility and VR glasses | Device | vr-supported hypnofertility |
Primary outcome
Fertility Preparedness Scale for Women Receiving Fertility Treatment
Time frame: Day 12
The scale is used for the assessment of the levels of stress experienced by infertile couples. As a Likert-type scale, it has three sub-scales in relation to personal, marital and social domains and contains a total of 14 items. 'Stress in personal domain' sub-scale contains six items, and the minimum and maximum scores to be obtained from it are successively 0 and 20 points. 'Stress in marital domain' sub-scale has four items, and the minimum and maximum scores to be obtained from it are successively 0 and 14 points. 'Stress in social domain' sub-scale is comprised of four items, and the minimum and maximum scores to be obtained from it are successively 0 and 12 points. A high score to be obtained from the sub-scale refers to the increase in the stress level.
The Copenhagen Multi-centre Psychosocial Infertility Fertility Problem Stress
Time frame: Day 12
The scale is used for the assessment of the levels of stress experienced by infertile couples. As a Likert-type scale, it has three sub-scales in relation to personal, marital and social domains and contains a total of 14 items. 'Stress in personal domain' sub-scale contains six items, and the minimum and maximum scores to be obtained from it are successively 0 and 20 points. 'Stress in marital domain' sub-scale has four items, and the minimum and maximum scores to be obtained from it are successively 0 and 14 points. 'Stress in social domain' sub-scale is comprised of four items, and the minimum and maximum scores to be obtained from it are successively 0 and 12 points. A high score to be obtained from the sub-scale refers to the increase in the stress level.
The Copenhagen Multi-centre Psychosocial Infertility Coping Strategy Scale
Time frame: Day 12
The scale contains 19 items and has four sub-scales. The minimum and maximum scores to be obtained from the sub-scale of 'active-avoidance' coping method which is comprised of four items are successively 4 and 16 points. The sub-scale of 'active-confronting' coping method contains seven items. The minimum and maximum scores to be obtained from this sub-scale are successively 7 and 26 points. The minimum and maximum scores to be obtained from the sub-scale of 'passive-avoidance' coping method which is comprised of three items are successively 3 and 12 points. The sub-scale of 'meaning-based' coping method contains five items. The minimum and maximum scores to be obtained from this sub-scale are successively 5 and 20 points. A higher score to be obtained from the subscale means that the method is used more when coping with with stress.
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 16 Feb 2021.
- Derived from this study: PubMed 36513620Erdemoglu C, Aksoy Derya Y. The effect of hypnofertility on fertility preparedness, stress, and coping with stress in women having in vitro fertilization: A randomized controlled trial. J Reprod Infant Psychol. 2024 Jul;42(4):569-580. doi: 10.1080/02646838.2022.2156488. Epub 2022 Dec 13.
- Individual participant dataSharing planned: No. There is no plan to make individual participant data (IPD) available to other researchers. Because the institution where the research was conducted does not allow this.
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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.
Yeşim Aksoy Derya, Phd study director
Inonu University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing VR Glasses in people with Fertilization in Vitro, run by Adiyaman University 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 1 inclusion and 1 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 16 Feb 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?
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?
Fertility Preparedness Scale for Women Receiving Fertility Treatment (time frame: Day 12). The study lists 3 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 NCT04755270, which also lists 1 linked publication.
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 16 Feb 2021.