An Intervention on Psychosocial Health in Women With Unsuccessful IVF Experience

NCT06426472 | Not Yet Recruiting

• 2 other identifiers: EBIstanbulUC1649B032306898
• Study Type: interventional
• Target: 120
• Locations: 0 countries
• Sites: N/A

Brief Summary

The goal of this interventional study is to learn if web-based support program can improve the psychosocial health status in women with unsuccessful IVF experience. The main questions it aims to answer are: Does web-based support decrease the depressive symptoms, anxiety and infertility-related stress? Does web-based support decrease the hopelessness? Does web-based support increase the coping skills with infertility-related stress? Researchers will compare this intervention to a control group to see if web-based support program improves psychosocial health. Participants will: Use the web-based support intervention for 5 weeks or have no intervention. Complete the surveys on the website before and after the intervention.

Conditions

Infertility; Failed in Vitro Fertilisation

Keywords

infertility; web-based; support; psychosocial health

Outcome Measures

Primary Outcomes (3)

• Depression (Beck Depression Inventory)

  Beck Depression Inventory (BDI) will be used to evaluate the participants' anxiety outcome. This inventory, whose validity and reliability in Turkish was studied by Hisli (1989), consists of a total of 21 items and four interpreted sub-dimensions. The scoring of the scale is a four-point Likert type (0 = positive statements about depression; 3 = negative statements about depression). The total score that can be obtained from the scale varies between 0-63; 0-9 points indicate minimal depression, 10-16 points indicate mild depression, 17-29 points indicate moderate depression, and 30-63 points indicate severe depression.

  24 months

• Infertility-related stress (The Infertility Stress Scale)

  The Infertility Stress Scale will be used to assess participants' infertility-related stress. Schmidt (2006) developed this scale in 1996. In our country, the validity and reliability of the scale was studied by Şahin Yılmaz (2012). This scale is a scale with a total of 14 items consisting of three sub-dimensions and answers are given in a Lykert type. Calculations per subdimensions requires a special formula for each subdimension. An increase in score is interpreted as an increase in stress.

  24 months

• Coping Skills with Infertility Stress (Coping with Infertility Stress Scale)

  Coping with Infertility Stress Scale: Developed by Schmidt (2006) in 1996. In our country, the validity and reliability of the scale was studied by Şahin Yılmaz (2012). This scale is a scale with a total of 19 items consisting of four sub-dimensions. e Active-Struggle Coping, Passive-Struggle Coping, Passive-Ignoring Coping and Meaning-Based Coping Method. Each subscale score can be calculated seperately.

  24 months

Secondary Outcomes (2)

• Hopelessness

  24 months

• Effect of the Web-based study program

  24 months

Study Arms (2)

Intervention

EXPERIMENTAL

Interventional group which will be given the web-based fertility support

Other: Web-based support program

Control

NO INTERVENTION

Control group will not be given any intervention

Interventions

Web-based support program OTHER

Web-based support program for infertile women with failed IVF experience

Intervention

Eligibility Criteria

• Age: 21 Years+
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Having at least three repeated unsuccessful IVF experiences,
• Maximum one month has passed since the negative IVF experience,
• Participating in the study voluntarily,
• Being able to read, understand and communicate in Turkish.

You may not qualify if:

• Not having access to the internet/not knowing how to use it,
• Having any psychiatric disease/being in the 'severe depression' grade as a result of the Beck Depression Inventory,
• Having at least one living child.
• Spontaneous pregnancy occurring,
• Starting a new treatment cycle,
• Not continuing to monitor the modules on the website.

Sponsors & Collaborators

• Istanbul University - Cerrahpasa: lead

MeSH Terms

Conditions

Infertility

Condition Hierarchy (Ancestors)

Genital Diseases; Urogenital Diseases

Central Study Contacts

Elif Balkan, PhD Student

CONTACT

+90 5423513125; e.balkan96@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD Student

Study Record Dates

• First Submitted: May 14, 2024
• First Posted: May 23, 2024
• Study Start: May 30, 2025
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): August 30, 2026
• Last Updated: April 22, 2025

Record last verified: 2025-04