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| ID | Type | Description | Link |
|---|---|---|---|
| CCMO: NL2370504108 | |||
| METC: 08/233 |
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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.
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| Name | Class |
|---|---|
| Universitair Ziekenhuis Brussel | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Start rFSH cycle day 2 | Experimental |
| |
| Start rFSH on cycle day 5 | Experimental |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mild stimulation | Drug | Fixed daily dose of 150 IU rFSH start cycle day 5 or day 2 depending on the Arm |
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| Measure | Description | Time Frame |
|---|---|---|
| Proportion of Top Embryos Per OPU. | Proportion of top embryos per ovum pick-up | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Cumulus Oocyte Complexes Obtained | Number of cumulus oocyte complexes obtained after ovum pick-up | one year |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Bart C Fauser, Prof, PhD | UMC Utrecht | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UZ Brussel | Brussels | 1090 | Belgium | |||
| University Medical Center Utrecht |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 12519847 | Background | Hohmann FP, Macklon NS, Fauser BC. A randomized comparison of two ovarian stimulation protocols with gonadotropin-releasing hormone (GnRH) antagonist cotreatment for in vitro fertilization commencing recombinant follicle-stimulating hormone on cycle day 2 or 5 with the standard long GnRH agonist protocol. J Clin Endocrinol Metab. 2003 Jan;88(1):166-73. doi: 10.1210/jc.2002-020788. |
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Patients who didn't completed the trial were cancelled before OPU due to low- or hyperresponse or before ET due to total fertilisation failure or no embryo to transfer.
Patients were recuited between 11-9-2008 and 1-10-2010 in both centers.
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| ID | Title | Description |
|---|---|---|
| FG000 | Start rFSH Cycle Day 2 | Start 150 IU rFSH subcutaneously on cycle day 2 |
| FG001 | Start rFSH on Cycle Day 5 | Start 150 IU rFSH subcutaneously on cycle day 5 |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Utrecht |
| 3508 GA |
| Netherlands |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Start rFSH Cycle Day 2 | Start 150IU rFSH s.c. cycle day 2 |
| BG001 | Start rFSH on Cycle Day 5 | Start 150IU rFSH s.c. cycle day 5 |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
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| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Proportion of Top Embryos Per OPU. | Proportion of top embryos per ovum pick-up | ITT | Posted | Number | percentage embryos | 1 year |
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| Secondary | Number of Cumulus Oocyte Complexes Obtained | Number of cumulus oocyte complexes obtained after ovum pick-up | Posted | Mean | Standard Deviation | oocytes | one year |
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2 years
Diary at the time of oocyte pick-up
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Start rFSH Cycle Day 2 | Start 150IU rFSH s.c. cycle day 2 | 0 | 80 | 0 | 80 | ||
| EG001 | Start rFSH on Cycle Day 5 | Start 150IU rFSH s.c. cycle day 2=5 | 0 | 67 | 0 | 67 |
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Early termination of the trial lead to small number of subjects to be analyzed. Only half of the expected patients were included.
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Prof. dr. B.C.J.M. Fauser | UMC Utrecht | +31-88-7557524 | b.c.fauser@umcutrecht.nl |
| ID | Term |
|---|---|
| C571802 | follitropin beta |
| C061018 | ganirelix |
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| >=65 years |
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| Male |
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| Netherlands |
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