Coping Intervention After Embryo Transfer

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Bart CJM Fauser, UMC Utrecht
ClinicalTrials.gov Identifier:
NCT01701011
First received: October 6, 2010
Last updated: May 18, 2016
Last verified: May 2016

October 6, 2010
May 18, 2016
October 2010
February 2013   (final data collection date for primary outcome measure)
Anxiety [ Time Frame: T1 during the first week of the stimulation phase, T2 on the 10th day after embryo transfer, T3 six weeks after embryo transfer ] [ Designated as safety issue: No ]
The Hospital Anxiety and Depression Scale (HADS) was used to measure general anxiety and depression (Zigmond and Snaith, 1983). TheHADSconsists of 14 items (7 items for each subscale) that are rated on a 4-point Likert scale. The total score is the sum of the 14 items, and for each subscale the score is the sum of the respective seven items (ranging from 0 to 21). Scores on each scale can be interpreted in ranges: normal (0-7), mild (8-10), moderate (11-14) and severe (15-21) anxiety and depression.
  • 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 ]
Complete list of historical versions of study NCT01701011 on ClinicalTrials.gov Archive Site
Depression [ Time Frame: T1 during the first week of the stimulation phase, T2 on the 10th day after embryo transfer, T3 six weeks after embryo transfer ] [ Designated as safety issue: No ]
The Hospital Anxiety and Depression Scale (HADS) was used to measure general anxiety and depression (Zigmond and Snaith, 1983). TheHADSconsists of 14 items (7 items for each subscale) that are rated on a 4-point Likert scale. The total score is the sum of the 14 items, and for each subscale the score is the sum of the respective seven items (ranging from 0 to 21). Scores on each scale can be interpreted in ranges: normal (0-7), mild (8-10), moderate (11-14) and severe (15-21) anxiety and depression.
Not Provided
Not Provided
Not Provided
 
Coping Intervention After Embryo Transfer
Study of the Effectiveness of a Coping Selfhelp Intervention for Women in the Waiting Period After an Embryo Transfer During an IVF/ISCI Treatment

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
  • Anxiety
  • Depression
Behavioral: Coping intervention
Positive reappraisal coping intervention
  • Experimental: PRCI-monitoring
    Coping intervention, Daily Record Keeping, Questionnaires
    Intervention: Behavioral: Coping intervention
  • No Intervention: Routine care control
    Questionnaires
  • No Intervention: Monitoring control
    DRK and Questionnaires

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
377
February 2013
February 2013   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Patient in IVF/ICSI treatment

Exclusion Criteria:

  • Patient who do not speak the dutch language
Female
Child, Adult, Senior
Yes
Contact information is only displayed when the study is recruiting subjects
Netherlands
 
NCT01701011
PRCI study
No
Not Provided
Not Provided
Bart CJM Fauser, UMC Utrecht
Bart CJM Fauser
Not Provided
Principal Investigator: N.S. Macklon, MD, PhD University of Southampton
Principal Investigator: J Boivin, PhD Cardiff University
UMC Utrecht
May 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP