Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Care Provider, Investigator)
Conditions Anxiety
Depression
Intervention Behavioral: Coping intervention
Enrollment 377
Recruitment Details In the 20 months of recruitment, between October 2010 and June 2012, 1445 letters were sent to women with an invitation to the trial.
Pre-assignment Details Of the 565 women who replied via a letter or email, 188 (33%) were not eligible. The remaining 377 women were randomised and the 349 who had an embryo to transfer (n=119 PRCI-monitoring, n=117 monitoring-control, n=113 routine care control)
Arm/Group Title PRCI-monitoring Group Monitoring-control Group Routine Care Control Group
Hide Arm/Group Description Coping intervention, Daily Record Keeping, Questionnaires Daily Record Keeping and Questionnaires Patients receive only questionnaires
Period Title: Overall Study
Started 127 126 124
Completed 92 102 90
Not Completed 35 24 34
Arm/Group Title PRCI-monitoring Group Monitoring-control Group Routine Care Control Group Total
Hide Arm/Group Description

Coping intervention, Daily Record Keeping, Questionnaires

Coping intervention, Daily Record Keeping, Questionnaires :

DRK and Questionnaires

Coping intervention, Daily Record Keeping, Questionnaires :

Questionnaires

Coping intervention, Daily Record Keeping, Questionnaires :

Total of all reporting groups
Overall Number of Baseline Participants 127 126 124 377
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 127 participants 126 participants 124 participants 377 participants
34.9  (4.7) 34.6  (4.7) 34.8  (5.0) 34.8  (4.8)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 127 participants 126 participants 124 participants 377 participants
Female
127
 100.0%
126
 100.0%
124
 100.0%
377
 100.0%
Male
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Netherlands Number Analyzed 127 participants 126 participants 124 participants 377 participants
127 126 124 377
1.Primary Outcome
Title Anxiety
Hide Description 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.
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
Hide Outcome Measure Data
Hide Analysis Population Description
Only in women with embryo transfer
Arm/Group Title PRCI-monitoring Group Monitoring-control Group Routine Care Control Group
Hide Arm/Group Description:
Coping intervention, Daily Record Keeping, Questionnaires
Daily Record Keeping and Questionnaires
patients receive questionnaires
Overall Number of Participants Analyzed 119 117 113
Mean (Standard Error)
Unit of Measure: units on a scale
Time 1 6.279  (0.242) 6.223  (0.243) 6.095  (0.251)
Time 2 7.302  (0.269) 7.526  (0.249) 8.175  (0.272)
Time 3 5.798  (0.279) 5.571  (0.262) 6.317  (0.288)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Monitoring-control Group, Routine Care Control Group
Comments IBM SPSS Statistics 20 was used to perform the statistical analysis. A mixed model for repeated measures was used to examine the differences between the three groups over time for the primary outcome, anxiety. All models were estimated by the method of restricted maximum likelihood (REML) and the Compound Symmetry covariance structure was chosen for the repeated measures. The analysiswas performed according to the intention to treat.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.05
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection PRCI-monitoring Group, Monitoring-control Group, Routine Care Control Group
Comments To test the difference in psychological well-being between three groups with a power of 95%,a ¼ 0.05 and a medium effect size ( f ¼ 0.25), a total of 297 participants were required (99 patients per group). Taking into account a 20% attrition rate, at least 124 women had to be recruited in each group.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.05
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
2.Secondary Outcome
Title Depression
Hide Description 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.
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
Hide Outcome Measure Data
Hide Analysis Population Description
Only in women with embryo transfer
Arm/Group Title PRCI-monitoring Group Monitoring-control Group Routine Care Control Group
Hide Arm/Group Description:
Coping intervention, Daily Record Keeping, Questionnaires
Daily Record Keeping and Questionnaires
Patients receive only questionnaires
Overall Number of Participants Analyzed 119 117 113
Mean (Standard Error)
Unit of Measure: units on a scale
Time 1 3.389  (0.199) 3.391  (0.201) 3.269  (0.208)
Time 2 3.709  (0.222) 3.676  (0.206) 4.224  (0.225)
Time 3 3.983  (0.230) 3.708  (0.216) 3.736  (0.238)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Monitoring-control Group, Routine Care Control Group
Comments IBM SPSS Statistics 20 was used to perform the statistical analysis. A mixed model for repeated measures was used to examine the differences between the three groups over time for the secondary outcome, depression. All models were estimated by the method of restricted maximum likelihood (REML) and the Compound Symmetry covariance structure was chosen for the repeated measures. The analysiswas performed according to the intention to treat.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.05
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title PRCI-monitoring Group Monitoring-control Group Routine Care Control Group
Hide Arm/Group Description Coping intervention, Daily Record Keeping, Questionnaires Daily Record Keeping and Questionnaires patients received questionnaires
All-Cause Mortality
PRCI-monitoring Group Monitoring-control Group Routine Care Control Group
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/-- 
Hide Serious Adverse Events
PRCI-monitoring Group Monitoring-control Group Routine Care Control Group
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/127 (0.00%)   0/126 (0.00%)   0/124 (0.00%) 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
PRCI-monitoring Group Monitoring-control Group Routine Care Control Group
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/127 (0.00%)   0/126 (0.00%)   0/124 (0.00%) 
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Henrietta Ockhuijsen 1,*, Agnes van den Hoogen, Marinus Eijkemans , Nick Macklon, Jacky Boivin
Organization: UMCU
Phone: +31307553628
EMail: h.d.l.ockhuysen@umcutrecht.nl
Layout table for additonal information
Responsible Party: Bart CJM Fauser, UMC Utrecht
ClinicalTrials.gov Identifier: NCT01701011    
Other Study ID Numbers: PRCI study
First Submitted: October 6, 2010
First Posted: October 4, 2012
Results First Submitted: December 3, 2014
Results First Posted: December 22, 2014
Last Update Posted: August 10, 2016