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Sponsored by: |
UMC Utrecht |
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Information provided by: | UMC Utrecht |
ClinicalTrials.gov Identifier: | NCT00866034 |
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).
Condition | Intervention | Phase |
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In Vitro Fertilization Intracytoplasmic Sperm Injection |
Drug: Cetrotide (Ovarian stimulation) |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Parallel Assignment, Efficacy Study |
Official Title: | Prospective, Multicenter,Randomized Controlled Trial Towards Identifying the Optimal Cetrotide Treatment Protocol |
Estimated Enrollment: | 2430 |
Study Start Date: | February 2009 |
Estimated Study Completion Date: | May 2011 |
Estimated Primary Completion Date: | February 2011 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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CD2: Experimental
Early fixed start of a daily dose of 0.25mg Cetrotide on cycle day 2, together with the initiation of daily treatment with exogenous gonadotropins.
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Drug: Cetrotide (Ovarian stimulation)
Fixed start of a daily dose of 0.25mg Cetrotide on cycle day 2
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CD6: Experimental
Late fixed start of a daily dose of 0.25mg Cetrotide on cycle day 6. As in the other arm of the study, exogenous gonadotropins will commence on cycle day 2.
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Drug: Cetrotide (Ovarian stimulation)
Late fixed start of a daily dose of 0.25mg Cetrotide on cycle day 6.
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Ages Eligible for Study: | 18 Years to 39 Years |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Contact: Ouijdane Hamdine, MD | +31-88-7550927 | o.hamdine@umcutrecht.nl |
Contact: Nick S Macklon, Prof, PhD | +31-88-7557524 | n.s.macklon@umcutrecht.nl |
Netherlands | |
University Medical Center Utrecht | Recruiting |
Utrecht, Netherlands | |
Contact: Ouijdane Hamdine, MD +31-88-7550927 o.hamdine@umcutrecht.nl | |
Contact: Nick S Macklon, Prof, PhD +31-88-7557524 n.s.macklon@umcutrecht.nl | |
Principal Investigator: Nick S Macklon, Prof, PhD |
Principal Investigator: | Nick S Macklon, Prof, PhD | University Medical Center Utrecht |
Responsible Party: | UMC Utrecht ( BCJM Fauser ) |
Study ID Numbers: | CETRO Trial, CCMO: NL23973.041.08, METC: 08-262/G-K |
Study First Received: | March 19, 2009 |
Last Updated: | March 19, 2009 |
ClinicalTrials.gov Identifier: | NCT00866034 History of Changes |
Health Authority: | Netherlands: The Central Committee on Research Involving Human Subjects (CCMO) |
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