In Vitro Fertilization Clinical Trial
Official title:
Prospective, Multicenter,Randomized Controlled Trial Towards Identifying the Optimal GnRH Antagonist Treatment Protocol
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).
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 |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Netherlands | University Medical Center Utrecht | Utrecht |
Lead Sponsor | Collaborator |
---|---|
Bart CJM Fauser |
Netherlands,
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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