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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 : January 29, 2019
Sponsor:
Collaborator:
Free University Medical Center
Information provided by (Responsible Party):
Bart CJM Fauser, UMC Utrecht

Study Description
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Brief Summary:

Background of the study:

Milder stimulation protocols have the advantage of being less expensive and more patient-friendly. Moreover, recent evidence suggests that mild stimulation protocols lead to lower embryo aneuploidy rates compared to conventional treatment regimens. Although with mild stimulation protocols the expected number of oocytes retrieved will be lower, pregnancy rates have shown to be similar possibly because embryo quality outfavours embryo quantity.

Objective of the study:

The aim of the study is to determine whether cycle day (CD) 5 start of stimulation will lead to better quality of embryos, based on morphology, than CD 2 start, in IVF with GnRH antagonist co-treatment started on a fixed day.

Study design:

Prospective randomized trial comparing two different starting days of ovarium stimulation (day 2 versus day 5) for IVF treatment.

Intervention:

One group wil start on cycle day 2 with stimulation of the ovaries with recombinant FSH. The other group will start on cycle day 5. Both group will start suppressing the gonadotrophin production of the the pituitary gland on cycle day 6 with a GnRH antagonist.

Primary study parameters/outcome of the study:

Primary outcome parameter is number of top embryos per ovum pick up.

Secondary study parameters/outcome of the study:

Secondary outcome measures are duration of stimulation, cancellation rate, fertilization rate, number of cumulus oocyte complexes obtained, number of mature oocytes obtained, number of top embryos per started cycle, amount of IU recFSH, and clinical pregnancy rate.


Condition or disease Intervention/treatment Phase
in Vitro Fertilization Ovulation Induction Drug: Mild stimulation Phase 4

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 147 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Among IVF Patients Undergoing Fixed Antagonist Protocols With Recombinant FSH, Does Administration of Recombinant FSH From Cycle Day 5 Onwards Compared With Cycle Day 2 Onwards, Yield a Higher Number of Good Quality Embryos?
Study Start Date : January 2009
Actual Primary Completion Date : October 2010
Actual Study Completion Date : October 2010

Resource links provided by the National Library of Medicine

Drug Information available for: Ganirelix

Arms and Interventions
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Arm Intervention/treatment
Experimental: Start rFSH cycle day 2 Drug: Mild stimulation
Fixed daily dose of 150 IU rFSH start cycle day 5 or day 2 depending on the Arm
Other Names:
  • Puregon
  • Ganirelix
Experimental: Start rFSH on cycle day 5 Drug: Mild stimulation
Fixed daily dose of 150 IU rFSH start cycle day 5 or day 2 depending on the Arm
Other Names:
  • Puregon
  • Ganirelix


Outcome Measures
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Primary Outcome Measures :
  1. Proportion of Top Embryos Per OPU. [ Time Frame: 1 year ]
    Proportion of top embryos per ovum pick-up


Secondary Outcome Measures :
  1. Number of Cumulus Oocyte Complexes Obtained [ Time Frame: one year ]
    Number of cumulus oocyte complexes obtained after ovum pick-up


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 36 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Female age < 36 years
  • FSH < 12 IU/l
  • BMI 18-29 kg/m2
  • Regular cycle (25-35 days)
  • No major uterine or ovarian abnormalities
  • No previous IVF cycles
  • Written informed consent

Exclusion Criteria:

  • Oocyte donation
  • Medical contra indication for pregnancy or IVF treatment
  • Endometriosis ≥ grade 3
  • Polycystic Ovarium Syndrome (PCOS)
  • Endocrine or metabolic abnormalities (pituitary, adrenal, pancreas, liver or kidney)
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00823472


Locations
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Belgium
UZ Brussel
Brussel, Belgium, 1090
Netherlands
University Medical Center Utrecht
Utrecht, Netherlands, 3508 GA
Sponsors and Collaborators
UMC Utrecht
Free University Medical Center
Investigators
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Principal Investigator: Bart C Fauser, Prof, PhD UMC Utrecht
More Information
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Publications:

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Responsible Party: Bart CJM Fauser, Professor, UMC Utrecht
ClinicalTrials.gov Identifier: NCT00823472    
Other Study ID Numbers: LITE study
CCMO: NL2370504108
METC: 08/233
First Posted: January 15, 2009    Key Record Dates
Results First Posted: December 2, 2010
Last Update Posted: January 29, 2019
Last Verified: January 2019
Keywords provided by Bart CJM Fauser, UMC Utrecht:
embryonic structures
sperm injections, intracytoplasmic
IVF
 GnRH antagonist
ovarian stimulation
cycle day 2 versus cycle day 5
Additional relevant MeSH terms:
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Ganirelix
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs