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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
Enrollment 147
Recruitment Details Patients were recuited between 11-9-2008 and 1-10-2010 in both centers.
Pre-assignment Details 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.
Arm/Group Title Start rFSH Cycle Day 2 Start rFSH on Cycle Day 5
Hide Arm/Group Description [Not Specified] [Not Specified]
Period Title: Overall Study
Started 80 67
Completed 56 39
Not Completed 24 28
Reason Not Completed
Physician Decision             24             28
Arm/Group Title Start rFSH Cycle Day 2 Start rFSH on Cycle Day 5 Total
Hide Arm/Group Description [Not Specified] [Not Specified] Total of all reporting groups
Overall Number of Baseline Participants 80 67 147
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 80 participants 67 participants 147 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
80
 100.0%
67
 100.0%
147
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 80 participants 67 participants 147 participants
31.0  (3.5) 31.1  (4.4) 31.0  (4.0)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 80 participants 67 participants 147 participants
Female
80
 100.0%
67
 100.0%
147
 100.0%
Male
0
   0.0%
0
   0.0%
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 80 participants 67 participants 147 participants
Belgium 49 39 88
Netherlands 31 28 59
1.Primary Outcome
Title Proportion of Top Embryos Per OPU.
Hide Description [Not Specified]
Time Frame 1 year
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
ITT
Arm/Group Title Start rFSH Cycle Day 2 Start rFSH on Cycle Day 5
Hide Arm/Group Description:
[Not Specified]
[Not Specified]
Overall Number of Participants Analyzed 80 67
Measure Type: Number
Unit of Measure: percentage embryos
51.1 41.8
2.Secondary Outcome
Title Number of Cumulus Oocyte Complexes Obtained
Hide Description [Not Specified]
Time Frame one year
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Start rFSH Cycle Day 2 Start rFSH on Cycle Day 5
Hide Arm/Group Description:
[Not Specified]
[Not Specified]
Overall Number of Participants Analyzed 80 67
Mean (Standard Deviation)
Unit of Measure: oocytes
9.8  (5.4) 8.5  (5.7)
Time Frame 2 years
Adverse Event Reporting Description Diary at the time of oocyte pick-up
 
Arm/Group Title Start rFSH Cycle Day 2 Start rFSH on Cycle Day 5
Hide Arm/Group Description [Not Specified] [Not Specified]
All-Cause Mortality
Start rFSH Cycle Day 2 Start rFSH on Cycle Day 5
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Start rFSH Cycle Day 2 Start rFSH on Cycle Day 5
Affected / at Risk (%) Affected / at Risk (%)
Total   0/0   0/0 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Start rFSH Cycle Day 2 Start rFSH on Cycle Day 5
Affected / at Risk (%) Affected / at Risk (%)
Total   0/0   0/0 
Early termination of the trial lead to small number of subjects to be analyzed. Only half of the expected patients were included.
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
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