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Cetrotide Treatment Optimization

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ClinicalTrials.gov Identifier: NCT00866034
Recruitment Status : Terminated (Due to limited rate of patient inclusion)
First Posted : March 20, 2009
Results First Posted : December 17, 2013
Last Update Posted : March 19, 2014
Sponsor:
Information provided by (Responsible Party):
Bart CJM Fauser, UMC Utrecht

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:

  • Normo-ovulatory women < 39 years with an indication for IVF or ICSI
  • No more than 2 previous unsuccessful IVF/ICSI cycles
  • BMI ≤ 32 kg/m2

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:

  • Early fixed start: start GnRH antagonist treatment with Cetrotide 0.25 mg on the same day as FSH, cycle day 2.
  • Late fixed start: FSH will be administered from cycle day 2. GnRH antagonist treatment with Cetrotide 0.25 mg will commence on cycle day 6.

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.The aim of this substudy was therefore to prospectively compare the effect of a cycle day 2 versus cycle day 6 fixed start GnRH antagonist protocol on LH, estradiol and progesterone levels in the mid and late follicular phase. In order to investigate whether the early fixed protocol exerts a significant extra burden on patients compared to the late start protocol, another group of 200 participants at the UMCU will be requested to complete the HADS questionnaire (Hospital Anxiety and Depression Scale).


Condition or disease Intervention/treatment Phase
In Vitro Fertilization Intracytoplasmic Sperm Injection Drug: Cetrotide (Ovarian stimulation) Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 617 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Prospective, Multicenter,Randomized Controlled Trial Towards Identifying the Optimal GnRH Antagonist Treatment Protocol
Study Start Date : February 2009
Actual Primary Completion Date : October 2012
Actual Study Completion Date : October 2012

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: CD2
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.
Drug: Cetrotide (Ovarian stimulation)
Fixed start of a daily dose of 0.25mg Cetrotide on cycle day 2
Other Names:
  • Gonal-F
  • Cetrorelix

Experimental: CD6
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.
Drug: Cetrotide (Ovarian stimulation)
Late fixed start of a daily dose of 0.25mg Cetrotide on cycle day 6.
Other Names:
  • Gonal-F
  • Cetrorelix




Primary Outcome Measures :
  1. Live Birth Rate Per Started Cycle and Live Birth From Cryopreserved Embryos Originating From, and Occurring Within 6 Months of the Initial Treatment Cycle Will be Included in the Total Live Birth Rate Per Started Cycle. [ Time Frame: 2 years ]

Secondary Outcome Measures :
  1. Cumulative Ongoing Pregnancy Rate [ Time Frame: 2 years ]

Other Outcome Measures:
  1. Endocrine Profile in the Early, Mid and Late Follicular Phase. [ Time Frame: 2 years ]
    1. difference in endocrine profile between the 2 arms during the mid and late follicular phase
    2. influence of early elevated follicular phase progesterone levels on clinical outcome



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Ages Eligible for Study:   18 Years to 39 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Normo-ovulatory women < 39 years with an indication for IVF or ICSI

Exclusion Criteria:

  • More than 2 previous unsuccessful IVF/ICSI cycles
  • BMI > 32 kg/m2

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00866034


Locations
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Netherlands
University Medical Center Utrecht
Utrecht, Netherlands
Sponsors and Collaborators
Bart CJM Fauser
Investigators
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Principal Investigator: Nick S Macklon, Prof, PhD UMC Utrecht

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Bart CJM Fauser, Professor of Reproductive Medicine and Gynecology, UMC Utrecht
ClinicalTrials.gov Identifier: NCT00866034     History of Changes
Other Study ID Numbers: CETRO Trial
CCMO: NL23973.041.08
METC: 08-262/G-K
First Posted: March 20, 2009    Key Record Dates
Results First Posted: December 17, 2013
Last Update Posted: March 19, 2014
Last Verified: February 2014

Keywords provided by Bart CJM Fauser, UMC Utrecht:
Cetrotide
IVF
ICSI
Treatment protocol

Additional relevant MeSH terms:
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Cetrorelix
Fertility Agents, Female
Fertility Agents
Reproductive Control Agents
Physiological Effects of Drugs
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists