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Not yet recruitingNCT06426472Updated Apr 22, 2025

An Intervention on Psychosocial Health in Women With Unsuccessful IVF Experience

An interventional study of Web-based support program in Infertility and Failed in Vitro Fertilisation, sponsored by Istanbul University - Cerrahpasa. Not yet recruiting. Open to female participants aged 21 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-04-22.

Sponsored by Istanbul University - Cerrahpasa · Not applicable, Interventional, and Supportive care

From the registry’s dates

  • Primary completion was expected by Jun 2026, 3 months ago, but the record still lists the study as not yet recruiting.
Phase
Not applicable
Study type
Interventional
Enrollment
120
Allocation
Randomized
Ages
21 Years and older
Sex
Female
01

Study 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.

02

Conditions studied

  • Infertility
  • Failed in Vitro Fertilisation

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Keywords

  • infertility
  • web-based
  • support
  • psychosocial health
03

In context

Infertility

2,506 studies on the registry are indexed under Infertility; 407 are open to participants now.

This study's planned enrollment of 120 is close to the median of 120 across 1,698 interventional studies indexed under Infertility.

Browse Infertility studies →

Lead sponsor

Istanbul University - Cerrahpasa is the lead sponsor of 680 studies on the registry; 208 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
21 Years and older
Sexes eligible
Female
Accepts healthy volunteers
Yes

Inclusion criteria

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

Exclusion criteria

Exclusion criteria

  1. Not having access to the internet/not knowing how to use it,
  2. Having any psychiatric disease/being in the 'severe depression' grade as a result of the Beck Depression Inventory,
  3. Having at least one living child.

Exclusion criteria from the study in the stages after including the study:

  1. Spontaneous pregnancy occurring,
  2. Starting a new treatment cycle,
  3. Not continuing to monitor the modules on the website.
05

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
120 participants (estimated)

Study arms

  • Experimental
    Intervention

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

    Other: Web-based support program

  • No intervention
    Control

    Control group will not be given any intervention

Interventions

  • OtherWeb-based support program

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

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 24 months

  2. 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.

    Time frame: 24 months

  3. 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.

    Time frame: 24 months

Secondary outcomes

  1. Hopelessness

    Beck Hopelessness Scale: Beck et al. (1974) to measure the individual's negative expectations for the future. Although the Turkish adaptation of this scale was made by Seber (1993), Durak (1994) examined the validity, reliability and factor structure of the scale in more detail. The scale consists of a total of 20 questions and the answers are given as true/false. The scale consists of three subscales: feelings about the future, loss of motivation, and expectations about the future. 1 point for incorrect answers to items 1-3-5-6-8-10-13-15 and 19, and 1 point for correct answers to items 2-4-7-9-11-14-16-17-18 and 20. and a total score between 0 and 20 can be obtained from the scale. The "arithmetic sum" found by calculation is accepted as the "despair score". The scale does not have a cut-off score; as the scores obtained from the scale increase, it is interpreted that the individual's level of hopelessness also increases.

    Time frame: 24 months

  2. Effect of the Web-based study program

    Web-Based Psychosocial Support Evaluation Form: It is an 8-question form created by researchers to evaluate opinions about the psychosocial support initiative applied to the web-based support program. System Usability Scale: The Turkish validity and reliability of the scale developed by Brooke (1996) was tested by Demirkol and Şeneler (2018). "The scale consisting of ten items is a five-point Likert type (1=Strongly Disagree, 2=Disagree, 3=Undecided, 4=Agree, 5=Strongly Agree)." Items numbered 1, 3, 5, 7, 9 in the scale are scored positively, and items numbered 2, 4, 6, 8, 10 are reverse scored because they contain negative expressions. The answer "I strongly disagree" is calculated as "0" and the answer "I strongly agree" is calculated as 4 points. To obtain the total score, the score from each item is multiplied by 2.5 to obtain a score ranging from 0 to 100. A score between 65-70 is sufficient to show that the website is usable.

    Time frame: 24 months

07

Study locations

No study locations are listed for this record.

08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 22, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT06426472
Lead sponsor
Istanbul University - Cerrahpasa
Responsible party
Elif Balkan (PhD Student, Istanbul University - Cerrahpasa) — Principal investigator
First posted
May 23, 2024
Start date
May 30, 2025 (estimated)
Primary completion
Jun 30, 2026 (estimated)
Completion
Aug 30, 2026 (estimated)
Last update
Apr 22, 2025

Study contacts

Elif Balkan, PhD Student
Contact
e.balkan96@hotmail.com
+90 5423513125

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Apr 2025. You cannot join it, but the record below documents what was studied.

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