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Coping Intervention After Embryo Transfer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01701011
Recruitment Status : Completed
First Posted : October 4, 2012
Results First Posted : December 22, 2014
Last Update Posted : August 10, 2016
Sponsor:
Information provided by (Responsible Party):
Bart CJM Fauser, UMC Utrecht

Tracking Information
First Submitted Date  ICMJE October 6, 2010
First Posted Date  ICMJE October 4, 2012
Results First Submitted Date  ICMJE December 3, 2014
Results First Posted Date  ICMJE December 22, 2014
Last Update Posted Date August 10, 2016
Study Start Date  ICMJE October 2010
Actual Primary Completion Date February 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 11, 2014)
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 ]
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.
Original Primary Outcome Measures  ICMJE
 (submitted: October 3, 2012)
  • Anxiety [ Time Frame: T1 during the first week of the stimulation phase ]
  • Anxiety [ Time Frame: T2 on the 10th day after embryotransfer ]
  • Anxiety [ Time Frame: T3 six weeks after embryotransfer ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: December 22, 2014)
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 ]
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.
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Coping Intervention After Embryo Transfer
Official Title  ICMJE Study of the Effectiveness of a Coping Selfhelp Intervention for Women in the Waiting Period After an Embryo Transfer During an IVF/ISCI Treatment
Brief Summary

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.

Detailed 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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Condition  ICMJE
  • Anxiety
  • Depression
Intervention  ICMJE Behavioral: Coping intervention
Positive reappraisal coping intervention
Study Arms  ICMJE
  • 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
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 8, 2013)
377
Original Estimated Enrollment  ICMJE
 (submitted: October 3, 2012)
372
Actual Study Completion Date  ICMJE February 2013
Actual Primary Completion Date February 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Patient in IVF/ICSI treatment

Exclusion Criteria:

  • Patient who do not speak the dutch language
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE Child, Adult, Older Adult
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Netherlands
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01701011
Other Study ID Numbers  ICMJE PRCI study
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Bart CJM Fauser, UMC Utrecht
Study Sponsor  ICMJE Bart CJM Fauser
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: N.S. Macklon, MD, PhD University of Southampton
Principal Investigator: J Boivin, PhD Cardiff University
PRS Account UMC Utrecht
Verification Date June 2016

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