Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE4
300 participants
INTERVENTIONAL
2016-01-31
2023-12-31
Brief Summary
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300 patients will be randomized in 2 arms:
1. control group: standard care rec FSH.
2. study group: modified dose of Rec FSH based on AFC with a correction factor based on BMI and basal AMH level.
Primary endpoints: number of mature follicles and eggs collected at egg retrieval; amount of rec FSH used.
Secondary endpoints: fertilization rate; cleavage rate; clinical pregnancy rate; inhibin B and AMH levels during ovarian stimulation.
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Detailed Description
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300 patients will be stimulated with rec FSH and an antagonist pituitary inhibition protocol, and randomized (at random computer generated numbers) in 2 arms:
1. control group: standard care recFSH based on age, basal FSH and AFC.
2. study group: modified dose of Rec FSH based on AFC with a correction factor based on BMI and basal AMH level.
FSH administration: 20IU per antral follicle (from 2-5mm) corrected as follows:
Correction factor for
AMH:
\<1 pMol/L X4 1-6 pMol/L X2 7-18 pMol/L X1 \>18 pMol/L X0.5 BMI 16.5-18.5 X0.75 18.5-25 X1 25-30 X1.25 30-35 X1.5 35-40 X2 Primary endpoints: number of mature follicles and eggs collected at egg retrieval; amount of rec FSH used.
Secondary endpoints: fertilization rate; cleavage rate; clinical pregnancy rate; inhibin B and AMH levels during ovarian stimulation.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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control group
standard care recFSH
recFSH
study group
modified dosage of recFSH for controlled ovarian stimulation based on AMH, BMI and AFC
recFSH
Interventions
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recFSH
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* untreated thyroid pathology
* hypogonadotropic hypogonadism
* untreaed hyperprolactinemia
* study drug hypersensitivity
* previous OHSS
* unilateral ovariectomy
* genital malformation
* BMI\>40
18 Years
43 Years
FEMALE
No
Sponsors
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Cliniques universitaires Saint-Luc- Université Catholique de Louvain
OTHER
Responsible Party
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Wyns
MD, PhD
Locations
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Cliniques universitaires Saint Luc
Brussels, , Belgium
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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AMH1
Identifier Type: -
Identifier Source: org_study_id
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