Cetrotide Treatment Optimization

In Vitro Fertilization Clinical Trial

Official title:

Prospective, Multicenter,Randomized Controlled Trial Towards Identifying the Optimal GnRH Antagonist Treatment Protocol

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

Related Conditions & MeSH terms

• In Vitro Fertilization
• Intracytoplasmic Sperm Injection

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