Cetrotide Treatment Optimization
Recruitment status was Recruiting
| Tracking Information | |||||||||
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| First Received Date ICMJE | March 19, 2009 | ||||||||
| Last Updated Date | March 19, 2009 | ||||||||
| Start Date ICMJE | February 2009 | ||||||||
| Estimated Primary Completion Date | February 2011 (final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE |
Live birth rate per started cycle [ Time Frame: 2 years ] [ Designated as safety issue: No ] | ||||||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||||||
| Change History | No Changes Posted | ||||||||
| Current Secondary Outcome Measures ICMJE |
Ongoing, clinical and biochemical pregnancy rate [ Time Frame: 2 years ] [ Designated as safety issue: No ] | ||||||||
| Original Secondary Outcome Measures ICMJE | Same as current | ||||||||
| Current Other Outcome Measures ICMJE | |||||||||
| Original Other Outcome Measures ICMJE | |||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | Cetrotide Treatment Optimization | ||||||||
| Official Title ICMJE | Prospective, Multicenter,Randomized Controlled Trial Towards Identifying the Optimal Cetrotide Treatment Protocol | ||||||||
| Brief Summary | Rationale: In daily practice fertility treatment is increasingly patient focused and innovative medication and standardized treatment guidelines are being developed to improve patient convenience. GnRH antagonist cotreatment to prevent premature luteinization during ovarian stimulation for IVF and ICSI greatly reduces the burden of treatment, partly by reducing the number of injections by around 21 compared with the optimal GnRH agonist 'long' protocol. However, the optimal GnRH antagonist protocol is still not known. There are a number of reasons to suggest that both the simplicity of treatment and clinical outcomes could be further improved by commencing GnRH antagonist treatment on the same day on which ovarian stimulation is started. These include more synchronized follicle development and reduced rates of premature luteinization. This study will investigate whether a novel early fixed start protocol improves outcomes in comparison to the widely employed late fixed start protocol. Objective: To demonstrate whether an early fixed start antagonist protocol improves the live birth rate compared with a late fixed start antagonist protocol by 5%. Study design: Prospective, multicenter, investigator sponsored, randomized controlled trial Study population:
Intervention: Two different GnRH antagonist treatment protocols used in daily practice will be compared. Patients will be randomized to receive one of the following two treatments:
Main study parameters/endpoints: The primary endpoint is the live birth rate per started cycle. A secondary endpoint is the number of embryos available for transfer. Nature and extent of the burden and risks associated with participation, benefit and group relatedness: In addition to recording clinical outcomes, endocrine studies will be carried out at the UMC Utrecht in a sample of 200 participants who will be subjected to blood sampling at three points during the treatment cycle: prior to commencing treatment on cycle day 2, cycle day 6 and the day of hCG administration. Another group of 200 participants at the UMCU will be requested to complete the HADS questionnaire (Hospital Anxiety and Depression Scale). |
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| Detailed Description | |||||||||
| Study Type ICMJE | Interventional | ||||||||
| Study Phase | Phase 4 | ||||||||
| Study Design ICMJE | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
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| Intervention ICMJE |
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| Publications * | |||||||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Recruiting | ||||||||
| Estimated Enrollment ICMJE | 2430 | ||||||||
| Estimated Completion Date | May 2011 | ||||||||
| Estimated Primary Completion Date | February 2011 (final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Female | ||||||||
| Ages | 18 Years to 39 Years | ||||||||
| Accepts Healthy Volunteers | Yes | ||||||||
| Contacts ICMJE |
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| Location Countries ICMJE | Netherlands | ||||||||
| Administrative Information | |||||||||
| NCT Number ICMJE | NCT00866034 | ||||||||
| Other Study ID Numbers ICMJE | CETRO Trial, CCMO: NL23973.041.08, METC: 08-262/G-K | ||||||||
| Has Data Monitoring Committee | Yes | ||||||||
| Responsible Party | BCJM Fauser, UMC Utrecht | ||||||||
| Study Sponsor ICMJE | UMC Utrecht | ||||||||
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| Information Provided By | UMC Utrecht | ||||||||
| Verification Date | March 2009 | ||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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