Involuntary Childlessness and Stress Management
Condition: Infertility
MeSH terms: Infertility
Study type: Interventional

Summary: 
      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: 
      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:

        1. The extent of psychosocial strain - does change happen in life satisfaction, emotional
           state and reactions, as well as with thoughts about childlessness and treatment.

        2. The result of the IVF treatment (pregnancy/non pregnancy)

        3. The adaptation to the (negative) treatment outcome - the impact of having participated
           in an EWI intervention group.

      Furthermore mediators and moderators will be explored.
    

Intervention name(s): Expressive writing; Active ctrl
Intervention type(s): Behavioral; Behavioral
Intervention description(s): 3 consecutive days of writing; Control
Other intervention name(s): EWI
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Supportive Care
Keywords: Involuntary childlessness; Infertility; IVF; EWI; Couples in IVF treatment; Psychosocial intervention