Coping Intervention After Embryo Transfer

Bart CJM Fauser

Status: Completed

Conditions: Depression; Anxiety

Treatments: Behavioral: Coping intervention

Study type: Interventional

Funder types: Other

Identifiers

NCT01701011

PRCI study

Details and patient eligibility

About

Background of the study:

Undergoing an IVF or ICSI treatment is an emotional and physical burden for both the woman and her partner. Most stressful for the couple is waiting for the result of the treatment, the period after the embryotransfer until the pregnancy test or menstruation and an unsuccessful treatment. Symptoms of anxiety and depression have been identified in couples during the waitingperiod after an embryotransfer. For this waitingperiod a short selfhelp copingintervention has been developed based on the stress theory of Lazarus for women to use at home. Goal of the instrument is to stimulate the copingstyle positive reappraisal. Research has demonstrated that using this copingstyle can have a positive impact in health related circumstances.

Full description

Objective of the study:

To investigate if a short copingintervention reduces anxiety in patients undergoing an IVF or ICSI treatment in the UMCU during the waitingperiod after an embryotransfer.

Study design:

In this research a randomised controlled trial (RCT) will be used for three groups. The choice for three groups has been based on earlier research with a daily record keeping (DRK). The DRK is a daily measurement for emotions, copingstyle and physical complaints. Previous research with the DRK showed an increase of anxiety. More research must be done of the impact of the DRK. Group 1: Positive Reappraisal Coping Intervention (PRCI) & DRK & questionnaires Group 2: DRK & questionnaires Group 3: Standard care & questionnaires

Study population:

Patients undergoing an IVF or ICSI treatment in the UMCU.

Intervention (if applicable):

A selfhelp coping intervention

Primary study parameters/outcome of the study:

Anxiety

Secondary study parameters/outcome of the study (if applicable):

Risk of emotional problems copingstyle depression vital pregnancy quality of life

Nature and extent of the burden and risks associated with participation, benefit and group relatedness (if applicable):

Using the coping intervention may reduce anxiety for the patient. The use of this instrument is not a burden for patients. The burden for patients is to complete questionnaires before, during and six weeks after the embryotransfer. Partners are asked to fill in a questionnaire at three times.

Enrollment: 377 patients

Sex: Female

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Patient in IVF/ICSI treatment

Exclusion criteria

• Patient who do not speak the dutch language

Trial design

377 participants in 3 patient groups

PRCI-monitoring

Experimental group

Description:

Coping intervention, Daily Record Keeping, Questionnaires

Treatment:

Behavioral: Coping intervention

Routine care control

No Intervention group

Description:

Questionnaires

Monitoring control

No Intervention group

Description:

DRK and Questionnaires