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Trial Comparing Start Stimulation of Recombinant Follicle Stimulating Hormone (rFSH) on Cycle Day 2 Versus Cycle Day 5 in In Vitro Fertilization (IVF) (LITE)

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ClinicalTrials.gov Identifier: NCT00823472
Recruitment Status : Terminated (Inclusion of the study didn't go as fast as expected. Expect: 234 patients in 1 year in 2 centers. After 1,5 year only 147 patients were recruited.)
First Posted : January 15, 2009
Results First Posted : December 2, 2010
Last Update Posted : December 2, 2010
Sponsor:
Collaborator:
Free University Medical Center
Information provided by:
UMC Utrecht

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions: In Vitro Fertilization
Ovulation Induction
Intervention: Drug: Mild stimulation

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Patients were recuited between 11-9-2008 and 1-10-2010 in both centers.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Patients who didn't completed the trial were cancelled before OPU due to low- or hyperresponse or before ET due to total fertilisation failure or no embryo to transfer.

Reporting Groups
  Description
Start rFSH Cycle Day 2 No text entered.
Start rFSH on Cycle Day 5 No text entered.

Participant Flow:   Overall Study
    Start rFSH Cycle Day 2   Start rFSH on Cycle Day 5
STARTED   80   67 
COMPLETED   56   39 
NOT COMPLETED   24   28 
Physician Decision                24                28 



  Baseline Characteristics

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
Start rFSH Cycle Day 2 No text entered.
Start rFSH on Cycle Day 5 No text entered.
Total Total of all reporting groups

Baseline Measures
   Start rFSH Cycle Day 2   Start rFSH on Cycle Day 5   Total 
Overall Participants Analyzed 
[Units: Participants]
 80   67   147 
Age 
[Units: Participants]
     
<=18 years   0   0   0 
Between 18 and 65 years   80   67   147 
>=65 years   0   0   0 
Age 
[Units: Years]
Mean (Standard Deviation)
 31.0  (3.5)   31.1  (4.4)   31.0  (4.0) 
Gender 
[Units: Participants]
     
Female   80   67   147 
Male   0   0   0 
Region of Enrollment 
[Units: Participants]
     
Belgium   49   39   88 
Netherlands   31   28   59 


  Outcome Measures

1.  Primary:   Proportion of Top Embryos Per OPU.   [ Time Frame: 1 year ]

2.  Secondary:   Number of Cumulus Oocyte Complexes Obtained   [ Time Frame: one year ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

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
Early termination of the trial lead to small number of subjects to be analyzed. Only half of the expected patients were included.


  More Information

Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Prof. dr. B.C.J.M. Fauser
Organization: UMC Utrecht
phone: +31-88-7557524
e-mail: b.c.fauser@umcutrecht.nl


Publications:

Responsible Party: BCJM Fauser, UMC Utrecht
ClinicalTrials.gov Identifier: NCT00823472     History of Changes
Other Study ID Numbers: LITE study
CCMO: NL2370504108
METC: 08/233
First Submitted: January 13, 2009
First Posted: January 15, 2009
Results First Submitted: November 2, 2010
Results First Posted: December 2, 2010
Last Update Posted: December 2, 2010