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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: June 28, 2016
Last verified: June 2016
Results First Received: December 3, 2014  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator)
Conditions: Anxiety
Depression
Intervention: Behavioral: Coping intervention

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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)

Reporting Groups
  Description
PRCI-monitoring Group Coping intervention, Daily Record Keeping, Questionnaires
Monitoring-control Group Daily Record Keeping and Questionnaires
Routine Care Control Group Patients receive only questionnaires

Participant Flow:   Overall Study
    PRCI-monitoring Group   Monitoring-control Group   Routine Care Control Group
STARTED   127   126   124 
COMPLETED   92   102   90 
NOT COMPLETED   35   24   34 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
PRCI-monitoring Group

Coping intervention, Daily Record Keeping, Questionnaires

Coping intervention, Daily Record Keeping, Questionnaires :

Monitoring-control Group

DRK and Questionnaires

Coping intervention, Daily Record Keeping, Questionnaires :

Routine Care Control Group

Questionnaires

Coping intervention, Daily Record Keeping, Questionnaires :

Total Total of all reporting groups

Baseline Measures
   PRCI-monitoring Group   Monitoring-control Group   Routine Care Control Group   Total 
Overall Participants Analyzed 
[Units: Participants]
 127   126   124   377 
Age 
[Units: Years]
Mean (Standard Deviation)
 34.9  (4.7)   34.6  (4.7)   34.8  (5.0)   34.8  (4.8) 
Gender 
[Units: Participants]
       
Female   127   126   124   377 
Male   0   0   0   0 
Region of Enrollment 
[Units: Participants]
       
Netherlands   127   126   124   377 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   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 ]

2.  Secondary:   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 ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Henrietta Ockhuijsen 1,*, Agnes van den Hoogen, Marinus Eijkemans , Nick Macklon, Jacky Boivin
Organization: UMCU
phone: +31307553628
e-mail: h.d.l.ockhuysen@umcutrecht.nl


Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Bart CJM Fauser, UMC Utrecht
ClinicalTrials.gov Identifier: NCT01701011     History of Changes
Other Study ID Numbers: PRCI study
Study First Received: October 6, 2010
Results First Received: December 3, 2014
Last Updated: June 28, 2016
Health Authority: Netherlands: Medical Ethics Review Committee (METC)