Hypnofertility for Women Undergoing In Vitro Fertilization (HWUIVF)
Primary Purpose
Infertility Unexplained, Fertility Disorders
Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Interventions Based on Hypnofertility
Routine clinical procedure
Sponsored by
About this trial
This is an interventional supportive care trial for Infertility Unexplained focused on measuring Hypnofertility, fertility preparedness, cortisol level, pregnancy outcome
Eligibility Criteria
Inclusion Criteria:
- primary infertility,
- unexplained infertility,
- going to undergo IVF treatment,
- fresh embryos,
- under 39 years of age
- having a smart phone
Exclusion Criteria:
- participated in any program to reduce stress
- having any psychiatric disorder
Sites / Locations
- Dokuz Eylul University
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Intervention
Control
Arm Description
Intervention Based on Hypnofertility
Routine clinical procedure
Outcomes
Primary Outcome Measures
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.
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.
Secondary Outcome Measures
pregnancy rate
result of pregnancy test
Full Information
NCT ID
NCT04141436
First Posted
October 10, 2019
Last Updated
October 24, 2019
Sponsor
Dokuz Eylul University
1. Study Identification
Unique Protocol Identification Number
NCT04141436
Brief Title
Hypnofertility for Women Undergoing In Vitro Fertilization (HWUIVF)
Official Title
Open Label, Randomized Controlled Trial, Effect of Hypnofertility on Fertility Preparedness, Cortisol Levels and Pregnancy Outcomes of Women Undergoing In Vitro Fertilization
Study Type
Interventional
2. Study Status
Record Verification Date
October 2019
Overall Recruitment Status
Completed
Study Start Date
November 8, 2017 (Actual)
Primary Completion Date
March 30, 2019 (Actual)
Study Completion Date
March 30, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Dokuz Eylul University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief 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.
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infertility Unexplained, Fertility Disorders
Keywords
Hypnofertility, fertility preparedness, cortisol level, pregnancy outcome
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
61 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Intervention
Arm Type
Experimental
Arm Description
Intervention Based on Hypnofertility
Arm Title
Control
Arm Type
Active Comparator
Arm Description
Routine clinical procedure
Intervention Type
Behavioral
Intervention Name(s)
Interventions Based on Hypnofertility
Intervention Description
Affirmation Visualization Imagination Relaxation
Intervention Type
Other
Intervention Name(s)
Routine clinical procedure
Intervention Description
Routine clinical procedure
Primary Outcome Measure Information:
Title
Fertility preparedness
Description
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.
Time Frame
through study completion, average 28 days
Title
cortisol levels
Description
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.
Time Frame
through study completion, average 28 days
Secondary Outcome Measure Information:
Title
pregnancy rate
Description
result of pregnancy test
Time Frame
through study completion, average 28 days
10. Eligibility
Sex
Female
Maximum Age & Unit of Time
39 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
primary infertility,
unexplained infertility,
going to undergo IVF treatment,
fresh embryos,
under 39 years of age
having a smart phone
Exclusion Criteria:
participated in any program to reduce stress
having any psychiatric disorder
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sevcan Fata
Organizational Affiliation
Dr.
Official's Role
Principal Investigator
Facility Information:
Facility Name
Dokuz Eylul University
City
Izmir
ZIP/Postal Code
35340
Country
Turkey
12. IPD Sharing Statement
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Hypnofertility for Women Undergoing In Vitro Fertilization (HWUIVF)
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