Coping Intervention After Embryo Transfer
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Purpose
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.
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.
| Condition | Intervention |
|---|---|
|
Anxiety Depression |
Behavioral: Coping intervention, Daily Record Keeping, Questionnaires |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator) |
| Official Title: | Study of the Effectiveness of a Coping Selfhelp Intervention for Women in the Waiting Period After an Embryo Transfer During an IVF/ISCI Treatment |
- Anxiety [ Time Frame: T1 during the first week of the stimulation phase ] [ Designated as safety issue: No ]
- Anxiety [ Time Frame: T2 on the 10th day after embryotransfer ] [ Designated as safety issue: No ]
- Anxiety [ Time Frame: T3 six weeks after embryotransfer ] [ Designated as safety issue: No ]
| Enrollment: | 377 |
| Study Start Date: | October 2010 |
| Study Completion Date: | February 2013 |
| Primary Completion Date: | February 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Coping intervention, Daily Record Keeping, Queationnaires
Coping intervention, Daily Record Keeping, Questionnaires
|
Behavioral: Coping intervention, Daily Record Keeping, Questionnaires |
|
Active Comparator: Questionnaires
Questionnaires
|
Behavioral: Coping intervention, Daily Record Keeping, Questionnaires |
|
Active Comparator: DRK and Questionnaires
DRK and Questionnaires
|
Behavioral: Coping intervention, Daily Record Keeping, Questionnaires |
Eligibility| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
- Patient in IVF/ICSI treatment
Exclusion Criteria:
- Patient who do not speak the dutch language
Contacts and Locations| Netherlands | |
| University Medical Center Utrecht | |
| Utrecht, Netherlands, : PO Box 85500 | |
| Principal Investigator: | N.S. Macklon, MD, PhD | University of Southampton |
| Principal Investigator: | J Boivin, PhD | Cardiff University |
More Information
No publications provided
| Responsible Party: | Bart CJM Fauser, prof, UMC Utrecht |
| ClinicalTrials.gov Identifier: | NCT01701011 History of Changes |
| Other Study ID Numbers: | PRCI study |
| Study First Received: | October 6, 2010 |
| Last Updated: | April 8, 2013 |
| Health Authority: | Netherlands: Medical Ethics Review Committee (METC) |
Keywords provided by UMC Utrecht:
|
coping intervention waiting-period |
Additional relevant MeSH terms:
|
Anxiety Disorders Depression Depressive Disorder |
Mental Disorders Behavioral Symptoms Mood Disorders |
ClinicalTrials.gov processed this record on May 16, 2013