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Completed

NCT Number: NCT06317571

Evaluation of The Effect of Fertility Support Education Given to Infertile Couples

The aim of the this study was to evaluate the effect of fertility support education given to infertile couples before treatment.

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Key information

Conditions

Infertility Genital Diseases Urogenital Diseases

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Manisa Celal Bayar Üniversitesi Hafsa Sultan Hastanesi

Manisa, 45060, Turkey (Türkiye)

About this study

Before the treatment, couples were given fertility support training for four weeks. After the treatment was completed, the couples' stress level and quality of life, women's self-efficacy, fertility readiness, cortisol levels and pregnancy outcomes were examined.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • diagnosed with primary infertility
  • have not received fertility support training before
  • can speak Turkish

Exclusion criteria

  • with psychiatric illness

Treatment and study plan

fertility support education

Behavioral

In the first module, female reproductive organs, the occurrence of pregnancy and the effect of stress on fertility are explained to women using models and training booklets. The effects of affirmation, which is one of the ways to positively affect the consciousness, and imagination, visualization and relaxation techniques, which are ways to positively affect the subconscious, on body and reproductive functions are explained. In the second module, women and their partners were also trained, and the effect of lifestyle on reproductive health was explained through the second module training booklet. In the third module, an example of a one-week program in which they could apply the methods described in the training before starting their treatments was introduced. In the fourth module, treatment process was explained to women and the practices described in the training were shared, which they could do to relax during this process.

Primary outcomes

  1. Infertility Stress Scale

    Time frame: two month

    This scale, which can be applied to both men and women, consists of three subscales and 14 items. The sub-dimensions of the scale are personal space, marital space and social space. A high score from the subscales of the scale indicates that stress has increased, while a low score indicates that stress has decreased.

  2. Infertility Self-Efficacy Scale-Short Form

    Time frame: two month

    The scale was developed to evaluate the self-efficacy perceptions of infertile individuals about their cognitive, emotional and behavioral skill strengths. A 10-item short form of this scale, which consists of 16 items, was created in 2006. A minimum of 8 and a maximum of 32 points are obtained from the scale, and the higher the score obtained from the scale, the higher the perception of self-efficacy is considered.

  3. Fertility Readiness Scale

    Time frame: two month

    The scale consists of three sub-dimensions: "Hope and Awareness", "Positive Emotions and Thoughts", and "Ready Body and Brain". Getting a high score on this scale indicates strong fertility readiness. The minimum score from the scale is 23 points and the maximum score is 115 points. The median score of this scale is 56 and it is stated that this score can be taken as the cut-off value. A score of 56 points or higher from the scale indicates that the woman feels more ready for pregnancy.

  4. Fertiqol Quality of Life Scale

    Time frame: two month

    The scale evaluates quality of life. The core module consists of four dimensions: emotional, mind-body, relational and social, and the treatment module consists of two sub-dimensions: treatment environment and treatment tolerance. The total score of the scale varies between 0-100, and an increase in the total score indicates an increase in the quality of life.

  5. Blood cortisol level

    Time frame: two month

    An increase in blood cortisol level indicates that stress increases, and a decrease indicates that stress decreases.

Sponsors and collaborators

Lead sponsor

Manisa Celal Bayar University

Other

Registry information

Important dates

Study start
2021
Primary completion
2021
Study completion
2022
First posted
Mar 19, 2024
Registry last updated
Mar 20, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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