Hypnofertility for Women Undergoing In Vitro Fertilization (HWUIVF)
Open Label, Randomized Controlled Trial, Effect of Hypnofertility on Fertility Preparedness, Cortisol Levels and Pregnancy Outcomes of Women Undergoing In Vitro Fertilization
1 other identifier
interventional
61
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Nov 2017
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 8, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 30, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
March 30, 2019
CompletedFirst Submitted
Initial submission to the registry
October 10, 2019
CompletedFirst Posted
Study publicly available on registry
October 28, 2019
CompletedOctober 28, 2019
October 1, 2019
1.4 years
October 10, 2019
October 24, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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.
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.
through study completion, average 28 days
Secondary Outcomes (1)
pregnancy rate
through study completion, average 28 days
Study Arms (2)
Intervention
EXPERIMENTALIntervention Based on Hypnofertility
Control
ACTIVE COMPARATORRoutine clinical procedure
Interventions
Affirmation Visualization Imagination Relaxation
Eligibility Criteria
You may qualify if:
- primary infertility,
- unexplained infertility,
- going to undergo IVF treatment,
- fresh embryos,
- under 39 years of age
- having a smart phone
You may not qualify if:
- participated in any program to reduce stress
- having any psychiatric disorder
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Dokuz Eylul University
Izmir, 35340, Turkey (Türkiye)
Study Officials
- PRINCIPAL INVESTIGATOR
Sevcan Fata
Dr.
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Director, Clinical research
Study Record Dates
First Submitted
October 10, 2019
First Posted
October 28, 2019
Study Start
November 8, 2017
Primary Completion
March 30, 2019
Study Completion
March 30, 2019
Last Updated
October 28, 2019
Record last verified: 2019-10