Clinical trial NCT02430740: Tailored Ovarian Stimulation Based on BMI, AMH, AFC
Official title: Multicentric Randomized Controlled Study to Determine a Tailored Strategy for Controlled Ovarian Stimulation in IVF Based on AMH, BMI and AFC
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Infertility
Keywords: Fertilization in Vitro
antagonist protocol
antral follicle count
Anti-Mullerian Hormone
Reproductive Techniques, Assisted
Lead sponsor: Cliniques universitaires Saint-Luc- Université Catholique de Louvain
Sponsor class: OTHER
First posted: 2015-04-30
Enrollment: 300
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 43
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: number of mature follicles
timeFrame: 2 years
measure: number of oocytes retrieved
timeFrame: 2 years
measure: rec FSH dose used
timeFrame: 2 years
Secondary outcomes:
measure: fertilization rate
timeFrame: 2 years
measure: cleavage rate
timeFrame: 2 years
measure: clinical pregnancy rate
timeFrame: 2 years
measure: AMH level during stimulation
timeFrame: 2 years
measure: Inhibin B level during stimulation
timeFrame: 2 years
Other outcomes:
Locations:
city: Brussels
country: Belgium
facility: Cliniques universitaires Saint Luc
Study officials:
References: