DRUG
Mild stimulation
Fixed daily dose of 150 IU rFSH start cycle day 5 or day 2 depending on the Arm
Status
Terminated
Phase
Phase 4
Enrollment
147
Locations
2
Results
Posted
Publications
1
Study 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.
Interventions
DRUG
Fixed daily dose of 150 IU rFSH start cycle day 5 or day 2 depending on the Arm
Timeline
First posted
Jan 15, 2009
Study start
Jan 2009
Primary completion
Oct 2010
Study completion
Oct 2010
Results posted
Dec 2, 2010
Registry updated
Jan 29, 2019
Outcomes
Proportion of Top Embryos Per OPU.
Time frame · 1 year
Proportion of top embryos per ovum pick-up
Number of Cumulus Oocyte Complexes Obtained
Time frame · one year
Number of cumulus oocyte complexes obtained after ovum pick-up
Eligibility
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)
Study locations
Belgium · Netherlands. Showing up to 24 locations stored in the fast local snapshot.
UZ Brussel
Brussels, Belgium
University Medical Center Utrecht
Utrecht, Netherlands
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Related PeptideStat pages
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