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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04141436
Other study ID # DOKUZ12345
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date November 8, 2017
Est. completion date March 30, 2019

Study information

Verified date October 2019
Source Dokuz Eylul University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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.


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).


Recruitment information / eligibility

Status Completed
Enrollment 61
Est. completion date March 30, 2019
Est. primary completion date March 30, 2019
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group N/A to 39 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Interventions Based on Hypnofertility
Affirmation Visualization Imagination Relaxation
Other:
Routine clinical procedure
Routine clinical procedure

Locations

Country Name City State
Turkey Dokuz Eylul University Izmir

Sponsors (1)

Lead Sponsor Collaborator
Dokuz Eylul University

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary Fertility preparedness Fertility Preparedness Scale for Women Receiving Fertility Support (FPS) The 5-point Likert scale was developed by Fata and Alus Tokat (Fata and Alus 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
Primary 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 pregnancy rate result of pregnancy test through study completion, average 28 days
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