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 has been 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.)
Sponsor:
Collaborator:
Free University Medical Center
Information provided by:
UMC Utrecht
ClinicalTrials.gov Identifier:
NCT00823472
First received: January 13, 2009
Last updated: November 2, 2010
Last verified: January 2009
  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 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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?

Resource links provided by NLM:


Further study details as provided by UMC Utrecht:

Primary Outcome Measures:
  • 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 ]

Enrollment: 147
Study Start Date: January 2009
Study Completion Date: October 2010
Primary Completion Date: October 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00823472

Locations
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
Principal Investigator: Bart C Fauser, Prof, PhD UMC Utrecht
  More Information

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
Study First Received: January 13, 2009
Results First Received: November 2, 2010
Last Updated: November 2, 2010
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

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

ClinicalTrials.gov processed this record on August 19, 2014