Involuntary Childlessness and Stress Management

Study Overview
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Brief Summary
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Many couples experience involuntary childlessness and seek treatment at fertility clinics. Going through treatment procedures can be very challenging, time consuming and emotionally demanding. Psychosocial intervention might have a soothing and healing effect on both behavior as well on physical matters. Hence, the investigators would like to investigate whether Expressive Writing Intervention (EWI) has an effect on stress management as well as on the pregnancy rate for couples who are going through fertility treatment.

Detailed Description
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Background: Around 10-14 % of all couples are experiencing involuntary childlessness. Most of these couples will be referred to the public health clinics in order to receive help by means of fertility treatment e.g. in vitro fertility (IVF) and numbers from the National board of Health indicates that the number is rising. It is well known that involuntary childlessness pose an enduring psychosocial burden and strain with feelings of hopelessness, despair, anger and frustration as well as anxiety and sadness. Much research points out that couples that receive IVF treatment to a great extent often experience stress and strong emotional oscillations during the treatment procedures. Some studies indicate that negative feelings as described above might have a negative impact on the chances of becoming pregnant. In spite of these findings there are only conducted very few controlled studies of intervention with this patient group, which might explain why it is still unclear whether infertile couples can benefit from therapeutic intervention. A growing number of studies in the area of health psychology has suggested that interventions where the participants has the opportunity to express themselves in writing about feelings, so-called Expressive Writing Intervention (EWI) seem to have a positive effect on physical health as well as mental well-being. Methods: Couples starting with their IVF treatment at the Fertility Clinic, Skejby Hospital will be invited to participate in the research project. Approximately 400 couples are expected to begin treatment during a one year period (We would like to enrol at least 144 couples). They will be randomized into a EWI group (writing about fertility related topics - emotional disclosure) and a control group (writing about neutral topics non-emotional disclosure). Inclusion criteria: Heterosexual couples as well as Homosexual couples 1st, 2nd and 3rd treatment cycles Can read and understand Danish Aged 18-40 years Exclusion criteria: • Patients with genetic diseases (PGD patients) The investigators would like to know more about whether EWI has an effect on: The extent of psychosocial strain - does change happen in life satisfaction, emotional state and reactions, as well as with thoughts about childlessness and treatment. The result of the IVF treatment (pregnancy/non pregnancy) The adaptation to the (negative) treatment outcome - the impact of having participated in an EWI intervention group. Furthermore mediators and moderators will be explored.

Official Title
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A Randomized Controlled Intervention Study: The Effect of Expressive Writing on Psychosocial Stress and Pregnancy Results With Couples Undergoing In Vitro Fertility(IVF) Treatment Due to Involuntary Childlessness.

Conditions
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Infertility

Intervention / Treatment
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* Behavioral: Expressive writing
* Behavioral: Active ctrl


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: heterosexual couples lesbian couples Exclusion Criteria: couples; where one of them suffers from a genetic disease

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: counselling<br>Does couples in IVF treatment benefit from emotional disclosure | Behavioral: Expressive writing<br>* 3 consecutive days of writing<br>* Other names: EWI;|
| Active Comparator: Control<br>Neutral writing exercise | Behavioral: Active ctrl<br>* Control<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The Effect of Expressive Writing Intervention on Fertility Related Stress | The COMPI 14-item self-rating instrument has been developed to capture specific thoughts and feelings in relation to involuntarily childlessness, which may lead to distress on 4-point and 5-point Likert scales. Responses cover personal, social, and marital domains with total scores ranging between 14 - 38, and higher scores indicating higher levels of infertility-related distress. Internal consistency (Cronbach's alpha) in the present study was 0.89 and the baseline to post-intervention test-retest correlation was 0.84. For the sub-domains the reliability of the scales were as follows; personal domain α=0.86, social domain α=0.83 and marital domain α=0.73. | follow-up 2 (3 months) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pregnancy Rate | How many women achieved pregnancy in each arm | measured at follow-up (t3) 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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IVF, Involuntary childlessness, Infertility, EWI, Couples in IVF treatment, Psychosocial intervention