Infertility UnexplainedNCT04141436
Hypnofertility for Women Undergoing In Vitro Fertilization (HWUIVF)
A study testing Interventions Based on Hypnofertility and Routine clinical procedure in people with Infertility Unexplained and Fertility Disorders, run by Dokuz Eylul University at 1 site in Turkey (Türkiye).
Trial summary
This randomized controlled study aimed to specify whether the interventions based on Hypnofertility would lead to increased fertility preparedness and pregnancy outcomes, decreased cortisol levels of women undergoing In Vitro Fertilization (IVF) treatment. Read more about this study
- Who is it for?
- Ages Up to 39 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Infertility Unexplained, Fertility Disorders
- What is being tested?
- Interventions Based on Hypnofertility and Routine clinical procedure
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 61 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 8 Nov 2017to 30 Mar 2019
- 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 Up to 39 years
- Women only
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- primary infertility,
- unexplained infertility,
- going to undergo IVF treatment,
- fresh embryos,
- under 39 years of age
- having a smart phone
Who cannot join
- participated in any program to reduce stress
- having any psychiatric disorder
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Open Label, Randomized Controlled Trial, Effect of Hypnofertility on Fertility Preparedness, Cortisol Levels and Pregnancy Outcomes of Women Undergoing In Vitro Fertilization
This randomized controlled study aimed to specify whether the interventions based on Hypnofertility would lead to increased fertility preparedness and pregnancy outcomes, decreased cortisol levels of women undergoing In Vitro Fertilization (IVF) treatment.
Read the detailed description
Objective: To specify whether the interventions based on Hypnofertility would lead to increased fertility preparedness and pregnancy outcomes, decreased cortisol levels of women undergoing In Vitro Fertilization (IVF) treatment.
Design: Randomized, controlled, prospective study. Setting: University Hospital Fertility Center in Izmir. Patients: Sixty-one women with unexplained infertility undergoing IVF treatment.
Interventions: Interventions based on Hypnofertility including affirmations, visualization, dreaming and relaxation from the first day of treatment to the day of pregnancy test.
Main Outcome Measures: Fertility preparedness and cortisol levels (primary outcomes), pregnancy rate (secondary outcome).
- Conditions
- Infertility Unexplained, Fertility Disorders
- Being tested
- Interventions Based on Hypnofertility, Routine clinical procedure
- Keywords
- Hypnofertility, fertility preparedness, cortisol level, pregnancy outcome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Interventions Based on HypnofertilityBehavioural
Affirmation Visualization Imagination Relaxation
Routine clinical procedureOther
Routine clinical procedure
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Intervention Based on Hypnofertility Receives: Behavioral: Interventions Based on Hypnofertility |
| Control | Active comparator | Routine clinical procedure Receives: Other: Routine clinical procedure |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fertility preparedness
Fertility Preparedness Scale for Women Receiving Fertility Support (FPS) The 5-point Likert scale was developed by Fata and Aluş Tokat (Fata and Aluş Tokat, 2019). This scale items consist only of positive words. The scale consists of 3 sub-dimensions: "Hope and Awareness"," Positive Feelings and Thoughts ","Prepared Body and Brain". Since the items consisted only of positive expressions, the score was calculated as they were. The scores of the items were 5 (strongly agree), 4 (agree), 3 (neutral), 2 (disagree) and 1 (strongly disagree), respectively. The minimum and maximum scores are 23 and 115, respectively. The median of the scale score is 56 points, which can be considered the cut value. If the scale score is below 56, it can be considered that the woman is not prepared for fertility. If the score is 56 and higher, it indicates greater fertility preparedness.
Measured: through study completion, average 28 days
cortisol levels
The saliva samples were collected in sterile urine containers provided by the researcher and stored in the refrigerator at a temperature between +4 and +8 degrees for a maximum of two (2) months. On average, they were sent to the laboratory every 15 days by means of carrying bags containing ice molds. Saliva was studied by LC-MS/MS (Liquid Chromatography-Mass Spectrometry) method by the expert staff of the laboratory.
Cortisol level (nmol/L) measurement was obtained for both intervention and control group in all face-to-face sessions. Because cortisol level have diurnal rythm and highest level is shown in the morning, samples were of all women in the morning once they came to clinic. Samples were to be collected with no eating, drinking, gum chewing or smoking in the 30 minutes prior to collection.
Measured: through study completion, average 28 days
Secondary outcomes (1)
pregnancy rate
result of pregnancy test
Measured: through study completion, average 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2019
- Study start8 Nov 2017
- Primary completion30 Mar 2019
- Study completion30 Mar 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Infertility UnexplainedStudies 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
- Masking
- None (open label)
- Enrolment
- 61 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dokuz Eylul University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sevcan Fata, Dokuz Eylul University
- Investigators
- Sevcan Fata, Principal investigator, Dr.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04141436
- Sponsor's protocol ID
- DOKUZ12345
- Status last verified
- Oct 2019
- First submitted
- 10 Oct 2019
- Last updated
- 28 Oct 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Open Label, Randomized Controlled Trial, Effect of Hypnofertility on Fertility Preparedness, Cortisol Levels and Pregnancy Outcomes of Women Undergoing In Vitro Fertilization
- ClinicalTrials.gov ID
- NCT04141436
- Acronym / sponsor ID
- DOKUZ12345
- Conditions
- Infertility Unexplained, Fertility Disorders
- Keywords
- Hypnofertility, fertility preparedness, cortisol level, pregnancy outcome
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 61 participants (actual)
- Lead sponsor
- Dokuz Eylul UniversityUniversity, hospital or other
- Study start
- 8 Nov 2017 (actual)
- Primary completion
- 30 Mar 2019 (actual)
- Study completion
- 30 Mar 2019 (actual)
- First posted
- 28 Oct 2019 (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 randomized controlled study aimed to specify whether the interventions based on Hypnofertility would lead to increased fertility preparedness and pregnancy outcomes, decreased cortisol levels of women undergoing In Vitro Fertilization (IVF) treatment.
Detailed description
Objective: To specify whether the interventions based on Hypnofertility would lead to increased fertility preparedness and pregnancy outcomes, decreased cortisol levels of women undergoing In Vitro Fertilization (IVF) treatment.
Design: Randomized, controlled, prospective study. Setting: University Hospital Fertility Center in Izmir. Patients: Sixty-one women with unexplained infertility undergoing IVF treatment.
Interventions: Interventions based on Hypnofertility including affirmations, visualization, dreaming and relaxation from the first day of treatment to the day of pregnancy test.
Main Outcome Measures: Fertility preparedness and cortisol levels (primary outcomes), pregnancy rate (secondary outcome).
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Behavioral: Interventions Based on HypnofertilityIntervention Based on Hypnofertility |
| Control | Active comparator | Other: Routine clinical procedureRoutine clinical procedure |
Who may qualify
- Ages
- Up to 39 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (6 listed)
- primary infertility,
- unexplained infertility,
- going to undergo IVF treatment,
- fresh embryos,
- under 39 years of age
Key exclusion criteria (2 listed)
- participated in any program to reduce stress
- having any psychiatric disorder
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 |
|---|---|---|
| Interventions Based on HypnofertilityAffirmation Visualization Imagination Relaxation | Behavioural | Intervention |
| Routine clinical procedureRoutine clinical procedure | Other | Control |
Primary outcome
Fertility preparedness
Time frame: through study completion, average 28 days
Fertility Preparedness Scale for Women Receiving Fertility Support (FPS) The 5-point Likert scale was developed by Fata and Aluş Tokat (Fata and Aluş Tokat, 2019). This scale items consist only of positive words. The scale consists of 3 sub-dimensions: "Hope and Awareness"," Positive Feelings and Thoughts ","Prepared Body and Brain". Since the items consisted only of positive expressions, the score was calculated as they were. The scores of the items were 5 (strongly agree), 4 (agree), 3 (neutral), 2 (disagree) and 1 (strongly disagree), respectively. The minimum and maximum scores are 23 and 115, respectively. The median of the scale score is 56 points, which can be considered the cut value. If the scale score is below 56, it can be considered that the woman is not prepared for fertility. If the score is 56 and higher, it indicates greater fertility preparedness.
cortisol levels
Time frame: through study completion, average 28 days
The saliva samples were collected in sterile urine containers provided by the researcher and stored in the refrigerator at a temperature between +4 and +8 degrees for a maximum of two (2) months. On average, they were sent to the laboratory every 15 days by means of carrying bags containing ice molds. Saliva was studied by LC-MS/MS (Liquid Chromatography-Mass Spectrometry) method by the expert staff of the laboratory. Cortisol level (nmol/L) measurement was obtained for both intervention and control group in all face-to-face sessions. Because cortisol level have diurnal rythm and highest level is shown in the morning, samples were of all women in the morning once they came to clinic. Samples were to be collected with no eating, drinking, gum chewing or smoking in the 30 minutes prior to collection.
1 secondary outcome
pregnancy rate
Time frame: through study completion, average 28 days
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 28 Oct 2019.
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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.
Sevcan Fata principal investigator
Dr.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Interventions Based on Hypnofertility and Routine clinical procedure in people with Infertility Unexplained and Fertility Disorders, run by Dokuz Eylul 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 6 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 28 Oct 2019. 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 (time frame: through study completion, average 28 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 28 Oct 2019.