Clinical trial NCT01187095: Involuntary Childlessness and Stress Management
Official title: 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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Infertility
Keywords: Involuntary childlessness
Infertility
IVF
EWI
Couples in IVF treatment
Psychosocial intervention
Lead sponsor: University of Aarhus
Sponsor class: OTHER
Collaborators: name: Aarhus University Hospital
First posted: 2010-08-23
Enrollment: 298
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief 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.

Eligibility criteria: Inclusion Criteria:

* heterosexual couples lesbian couples

Exclusion Criteria:

* couples; where one of them suffers from a genetic disease

Primary outcomes:
measure: The Effect of Expressive Writing Intervention on Fertility Related Stress
timeFrame: follow-up 2 (3 months)
Secondary outcomes:
measure: Pregnancy Rate
timeFrame: measured at follow-up (t3) 3 months
Other outcomes:
Locations:
city: Aarhus
country: Denmark
facility: Department of Psychology, Aarhus University
state: Jylland
Study officials:
affiliation: University of Aarhus
name: Bobby Zachariae, prof.med.,
role: PRINCIPAL_INVESTIGATOR
References:
citation: Philipsen MT, Knudsen UB, Zachariae R, Ingerslev HJ, Hvidt JEM, Frederiksen Y. Sleep, psychological distress, and clinical pregnancy outcome in women and their partners undergoing in vitro or intracytoplasmic sperm injection fertility treatment. Sleep Health. 2022 Apr;8(2):242-248. doi: 10.1016/j.sleh.2021.10.011. Epub 2021 Dec 20.
citation: Frederiksen Y, O'Toole MS, Mehlsen MY, Hauge B, Elbaek HO, Zachariae R, Ingerslev HJ. The effect of expressive writing intervention for infertile couples: a randomized controlled trial. Hum Reprod. 2017 Feb;32(2):391-402. doi: 10.1093/humrep/dew320. Epub 2016 Dec 21.