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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT00866034
Other study ID # CETRO Trial
Secondary ID CCMO: NL23973.04
Status Terminated
Phase Phase 4
First received March 19, 2009
Last updated February 4, 2014
Start date February 2009
Est. completion date October 2012

Study information

Verified date February 2014
Source UMC Utrecht
Contact n/a
Is FDA regulated No
Health authority Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
Study type Interventional

Clinical Trial 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).


Recruitment information / eligibility

Status Terminated
Enrollment 617
Est. completion date October 2012
Est. primary completion date October 2012
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 18 Years to 39 Years
Eligibility 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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment


Intervention

Drug:
Cetrotide (Ovarian stimulation)
Fixed start of a daily dose of 0.25mg Cetrotide on cycle day 2
Cetrotide (Ovarian stimulation)
Late fixed start of a daily dose of 0.25mg Cetrotide on cycle day 6.

Locations

Country Name City State
Netherlands University Medical Center Utrecht Utrecht

Sponsors (1)

Lead Sponsor Collaborator
Bart CJM Fauser

Country where clinical trial is conducted

Netherlands, 

Outcome

Type Measure Description Time frame Safety issue
Other Endocrine Profile in the Early, Mid and Late Follicular Phase. difference in endocrine profile between the 2 arms during the mid and late follicular phase
influence of early elevated follicular phase progesterone levels on clinical outcome
2 years No
Primary 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. 2 years No
Secondary Cumulative Ongoing Pregnancy Rate 2 years No
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