Hypnofertility for Women Undergoing In Vitro Fertilization (HWUIVF)

Fertility Disorders Clinical Trial

Official title:

Open Label, Randomized Controlled Trial, Effect of Hypnofertility on Fertility Preparedness, Cortisol Levels and Pregnancy Outcomes of Women Undergoing In Vitro Fertilization

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04141436
• Other study ID #: DOKUZ12345
• Status: Completed
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Fertility Disorders
• Infertility
• Infertility Unexplained

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