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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)
This study is currently recruiting participants.
Verified by UMC Utrecht, January 2009
First Received: January 13, 2009   No Changes Posted
Sponsors and Collaborators: UMC Utrecht
Free University Medical Center
Information provided by: UMC Utrecht
ClinicalTrials.gov Identifier: NCT00823472
  Purpose

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 Intervention Phase
In Vitro Fertilization
Ovulation Induction
Drug: Mild stimulation
Phase IV

Study Type: Interventional
Study Design: Treatment, Randomized, Open Label, Parallel Assignment, Efficacy Study
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?

Resource links provided by NLM:


Further study details as provided by UMC Utrecht:

Primary Outcome Measures:
  • Primary outcome parameter is proportion of top embryos per OPU. [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • number of cumulus oocyte complexes obtained [ Time Frame: one year ] [ Designated as safety issue: No ]

Estimated Enrollment: 234
Study Start Date: January 2009
Estimated Study Completion Date: March 2010
Estimated Primary Completion Date: January 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Start rFSH cycle day 2: Experimental Drug: Mild stimulation
Fixed daily dose of 150 IU rFSH start cycle day 5 or day 2 depending on the Arm
Start rFSH on cycle day 5: Experimental Drug: Mild stimulation
Fixed daily dose of 150 IU rFSH start cycle day 5 or day 2 depending on the Arm

  Eligibility

Ages Eligible for Study:   18 Years to 36 Years
Genders 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00823472

Contacts
Contact: Monique D Sterrenburg, MD +31-887551443 m.d.sterrenburg@umcutrecht.nl
Contact: Bart C Fauser, Prof, PhD +31-887557524 b.c.fauser@umcutrecht.nl

Locations
Belgium
UZ Brussel Recruiting
Brussel, Belgium, 1090
Contact: Christophe Blockeel, MD     +32-2-4776649     christophe.blockeel@uzbrussel.be    
Contact: Paul Devroey, Prof, PhD     +32-24776699     Paul.devroey@az.vub.ac.be    
Principal Investigator: Paul Devroey, Prof, PhD            
Netherlands
University Medical Center Utrecht Recruiting
Utrecht, Netherlands, 3508 GA
Contact: Monique Sterrenburg, MD     +31-887551443     m.d.sterrenburg@umcutrecht.nl    
Contact: Bart C Fauser, Prof, PhD     +31-887557524     b.c.fauser@umcutrecht.nl    
Principal Investigator: Bart C Fauser, Prof, PhD            
Sponsors and Collaborators
UMC Utrecht
Free University Medical Center
Investigators
Principal Investigator: Bart C Fauser, Prof, PhD University Medical Center Utrecht
  More Information

Publications:
Responsible Party: UMC Utrecht ( BCJM Fauser )
Study ID Numbers: LITE study, CCMO: NL2370504108, METC: 08/233
Study First Received: January 13, 2009
Last Updated: January 13, 2009
ClinicalTrials.gov Identifier: NCT00823472     History of Changes
Health Authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Keywords provided by UMC Utrecht:
embryonic structures
sperm injections, intracytoplasmic
IVF
GnRH antagonist
ovarian stimulation
cycle day 2 versus cycle day 5

Study placed in the following topic categories:
Ganirelix
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Hormones
Spastic Paraplegia Epilepsy Mental Retardation
Follicle Stimulating Hormone

Additional relevant MeSH terms:
Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists
Hormones
Pharmacologic Actions
Follicle Stimulating Hormone

ClinicalTrials.gov processed this record on September 01, 2009