Clinical trial
Multicentric Randomized Controlled Study to Determine a Tailored Strategy for Controlled Ovarian Stimulation in IVF Based on AMH, BMI and AFC
Name
AMH1
Description
The study objective is to develop a tailored based strategy for ovarian stimulation in IVF patients using AMH, BMI, antral follicle count (AFC).
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.
Trial arms
Trial start
2016-01-01
Estimated PCD
2023-12-01
Trial end
2023-12-01
Status
Recruiting
Phase
Early phase I
Treatment
recFSH
Arms:
control group, study group
Other names:
Gonal F, Puregon, Fostimon
Size
300
Primary endpoint
number of mature follicles
2 years
number of oocytes retrieved
2 years
rec FSH dose used
2 years
Eligibility criteria
Inclusion Criteria:
* female infertile patients eligible for IVF treatment
Exclusion Criteria:
* polycystic ovaries
* untreated thyroid pathology
* hypogonadotropic hypogonadism
* untreaed hyperprolactinemia
* study drug hypersensitivity
* previous OHSS
* unilateral ovariectomy
* genital malformation
* BMI\>40
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE4'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 300, 'type': 'ESTIMATED'}}
Updated at
2023-04-12
1 organization
1 product
1 indication
Organization
Cliniques Universitaires Saint-LucProduct
recFSHIndication
infertility