The Level of Infertility Distress and Fertility Readiness of Women

NCT06659497 | Recruiting

• 1 other identifier: 2024/50
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 2

Brief Summary

The infertility treatment process is a multidisciplinary teamwork involving different professional groups. Especially the Controlled Ovarian Hyperstimulation (COH) protocols applied during the infertility treatment process require good nursing education, close monitoring and effective counseling. The patient's education during this process, the development of self-administration skills and follow-up are the responsibility of the infertility nurse and directly affect the treatment process and its success. There is a need to determine the level of impact of infertile individuals on this process, to increase their knowledge level regarding the treatment process and to ensure that individuals are supported closely and strengthened during the treatment process. This study was planned as a randomized controlled experimental study to determine the effect of web-based training to be given to women who undergo Intrauterine Insemination (IUI) treatment on the level of impact of infertility and fertility readiness of women.

Conditions

Infertility; Intrauterine Insemination (IUI)

Keywords

Intrauterine insemination; infertility; nursing education; web based education

Outcome Measures

Primary Outcomes (1)

• Level of Infertility Affectedness

  In the research, the level of women's impact on infertility is measured with a Infertility Distress Scale. Infertility Distress Scale: The scale defines how people's cells and emotional states continue to be affected by infertility. The scale consists of a total of 21 items, 16 of which are direct and five are reverse. Reverse items are items 3, 10, 13, 14 and 21. The scale is a 4-point Likert type and positive items are scored as 1: never, 4: always, while negative items are scored the opposite way. A score between 21 and 84 is obtained from the scale. There is no cut-off score for the scale. High scores obtained from the scale indicate that the effect of infertility is high. In addition, there is no subscale of the operation. The reliability of the item scores of the scale is applied as 0.93.

  up to 5 months

Secondary Outcomes (1)

• Fertility Readiness

  up to 5 months

Study Arms (2)

intervention

EXPERIMENTAL

Patients in this group participate in a web-based training application. Patients are asked pre-test questions before the training and pre-test questions after the training.

Behavioral: web-based patient education

Control

NO INTERVENTION

No intervention is made for patients in this group. Patients are asked pre-test questions before treatment and pre-test questions after treatment.

Interventions

web-based patient education BEHAVIORAL

The web-based training, which will provide the following information about the IUI treatment process, will last a total of 60 minutes. MODULE 1: General Information About Fertility MODULE 2: Diagnostic and Therapeutic Methods in Infertility / Insemination Treatment MODULE 3: Drugs Used in Insemination Treatment and Their Application MODULE 4: Things to Consider After Insemination

intervention

Eligibility Criteria

• Age: 23 Years - 40 Years
• Gender Eligibility Details: The research is conducted only with infertile women
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Those who applied to Düzce University Health Application and Research Center Infertility Polyclinic between 15.03.2024-15.08.2024,
• Primary infertility,
• Those who are planned to use Controlled Ovarian Hyperstimulation (COH) in intrauterine insemination (IUI) treatment,
• Those who have the equipment (mobile phone, computer, tablet, internet, etc.) to access web-based education,
• Those who do not have a chronic disease,
• Those who do not have a diagnosed psychiatric disease,
• Those who agree to participate in the study,
• Those who have the ability to understand and comprehend the questionnaires

You may not qualify if:

• Those who are not planned to use Controlled Ovarian Hyperstimulation (COH) in intrauterine insemination (IUI),
• Those who give up on treatment,
• Those who have 3 or more graff follicle development on the day of insemination (treatment cancellation),
• Those who have 1 million or less sperm obtained on the day of insemination (treatment cancellation)

Sponsors & Collaborators

• Duzce University: lead

Study Sites (2)

Duzce University

Merkez, Düzce, (538) 692-4993, Turkey (Türkiye)

RECRUITING

Duzce University

Düzce, Konuralp, 81000, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Infertility

Condition Hierarchy (Ancestors)

Genital Diseases; Urogenital Diseases

Central Study Contacts

Hilal Karadeniz

CONTACT

05386924993; hilalkaradeniz1993@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Assistant Phd

Model Details: The research is being conducted as a randomized controlled experimental study to determine the effects of web-based training on the treatment process of women undergoing Intrauterine Insemination (IUI) treatment on the level of infertility, fertility readiness and pregnancy outcomes. There are 2 groups of subjects in the study as experimental and control. Block randomization was applied in determining the groups. In this direction, the following randomization steps were followed by the statistics expert in order to eliminate bias and increase the reliability of the study. Randomization was done according to the educational status of the women (primary school - secondary school, high school, university and above when grouped) in a way that homogeneity was ensured in each group and it was planned to be statistically re-evaluated at the end of the study.

Study Record Dates

• First Submitted: October 23, 2024
• First Posted: October 26, 2024
• Study Start: March 15, 2024
• Primary Completion: April 15, 2025
• Study Completion: August 15, 2025
• Last Updated: October 26, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

TU (2)