## Protocol Section
### Identification Module
**NCT ID:** NCT06426472

**Brief Title:** An Intervention on Psychosocial Health in Women With Unsuccessful IVF Experience

**Official Title:** The Effect of Web-Based Support Program on Psychosocial Health Status in Women With Unsuccessful IVF Experience

#### Organization Study ID Info
**ID:** EBIstanbulUC
#### Organization
**Class:** OTHER
**Full Name:** Istanbul University - Cerrahpasa (IUC)
#### Secondary ID Infos
**Domain:** TUBITAK
**ID:** 1649B032306898
**Type:** OTHER_GRANT
### Status Module
#### Completion Date
**Date:** 2025-08-30

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-23

**Type:** ACTUAL

**Last Update Submit Date:** 2024-05-17

**Overall Status:** NOT_YET_RECRUITING

#### Primary Completion Date
**Date:** 2025-06-30

**Type:** ESTIMATED

#### Start Date
**Date:** 2024-06-30

**Type:** ESTIMATED

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-23
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-14
**Study First Submit QC Date:** 2024-05-17
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** Istanbul University - Cerrahpasa (IUC)

#### Responsible Party

**Investigator Affiliation:** Istanbul University - Cerrahpasa (IUC)

**Investigator Full Name:** Elif Balkan

**Investigator Title:** PhD Student

**Type:** PRINCIPAL_INVESTIGATOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** False

### Description Module

**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 Module

**Conditions:**

- Infertility

- Failed in Vitro Fertilisation

**Keywords:**

- infertility

- web-based

- support

- psychosocial health

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

##### Masking Info

**Masking:** DOUBLE

**Who Masked:**

- PARTICIPANT

- INVESTIGATOR

**Primary Purpose:** SUPPORTIVE_CARE

#### Enrollment Info

**Count:** 120

**Type:** ESTIMATED

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

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

**Intervention Names:**

- Other: Web-based support program

**Label:** Intervention

**Type:** EXPERIMENTAL

#### Arm Group 2

**Description:** Control group will not be given any intervention

**Label:** Control

**Type:** NO_INTERVENTION

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Intervention

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

**Name:** Web-based support program

**Type:** OTHER

### Outcomes Module

#### Primary Outcomes

**Description:** 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.

**Measure:** Depression (Beck Depression Inventory)

**Time Frame:** 24 months

**Description:** 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.

**Measure:** Infertility-related stress (The Infertility Stress Scale)

**Time Frame:** 24 months

**Description:** 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.

**Measure:** Coping Skills with Infertility Stress (Coping with Infertility Stress Scale)

**Time Frame:** 24 months

#### Secondary Outcomes

**Description:** 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.

**Measure:** Hopelessness

**Time Frame:** 24 months

**Description:** 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.

**Measure:** Effect of the Web-based study program

**Time Frame:** 24 months

### Eligibility Module

**Eligibility Criteria:** 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

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.

**Gender Based:** True

**Healthy Volunteers:** True

**Minimum Age:** 21 Years

**Sex:** FEMALE

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** e.balkan96@hotmail.com

**Name:** Elif Balkan, PhD Student

**Phone:** +90 5423513125

**Role:** CONTACT

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000091662

- Term: Genital Diseases

- ID: D000091642

- Term: Urogenital Diseases

### Condition Browse Module - Browse Branches

- Abbrev: BXS

- Name: Urinary Tract, Sexual Organs, and Pregnancy Conditions

- Abbrev: All

- Name: All Conditions

### Condition Browse Module - Browse Leaves

- ID: M10290

- Name: Infertility

- Relevance: HIGH

- As Found: Infertility

- ID: M2876

- Name: Genital Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M2875

- Name: Urogenital Diseases

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000007246

- Term: Infertility

### Misc Info Module

- Version Holder: 2024-05-31
