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Sponsors and Collaborators: |
UMC Utrecht Free University Medical Center |
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Information provided by: | UMC Utrecht |
ClinicalTrials.gov Identifier: | NCT00823472 |
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 |
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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? |
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 |
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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
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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
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Ages Eligible for Study: | 18 Years to 36 Years |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
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 |
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 |
Principal Investigator: | Bart C Fauser, Prof, PhD | University Medical Center Utrecht |
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) |
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GnRH antagonist ovarian stimulation cycle day 2 versus cycle day 5 |
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