Tailored Ovarian Stimulation Based on BMI, AMH, AFC
- Conditions
- Infertility
- Interventions
- Drug: recFSH
- Registration Number
- NCT02430740
- Lead Sponsor
- Cliniques universitaires Saint-Luc- Université Catholique de Louvain
- Brief Summary
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.
- Detailed Description
The study objective is to develop a tailored based strategy for ovarian stimulation in IVF patients using AMH, BMI, AFC and inhibin B.
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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- Female
- Target Recruitment
- 300
- female infertile patients eligible for IVF treatment
- polycystic ovaries
- untreated thyroid pathology
- hypogonadotropic hypogonadism
- untreaed hyperprolactinemia
- study drug hypersensitivity
- previous OHSS
- unilateral ovariectomy
- genital malformation
- BMI>40
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description control group recFSH standard care recFSH study group recFSH modified dosage of recFSH for controlled ovarian stimulation based on AMH, BMI and AFC
- Primary Outcome Measures
Name Time Method number of oocytes retrieved 2 years number of mature follicles 2 years rec FSH dose used 2 years
- Secondary Outcome Measures
Name Time Method AMH level during stimulation 2 years fertilization rate 2 years cleavage rate 2 years clinical pregnancy rate 2 years Inhibin B level during stimulation 2 years
Trial Locations
- Locations (1)
Cliniques universitaires Saint Luc
🇧🇪Brussels, Belgium