Tailored Ovarian Stimulation Based on BMI, AMH, AFC

Cliniques universitaires Saint-Luc- Université Catholique de Louvain

Status and phase: Enrolling; Phase 4

Conditions: Infertility

Treatments: Drug: recFSH

Study type: Interventional

Funder types: Other

Identifiers

NCT02430740

AMH1

Details and patient eligibility

About

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.

Full 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.

Enrollment: 300 estimated patients

Sex: Female

Ages: 18 to 43 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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300 participants in 2 patient groups

control group

Other group

Description:

standard care recFSH

Treatment:

Drug: recFSH

study group

Experimental group

Description:

modified dosage of recFSH for controlled ovarian stimulation based on AMH, BMI and AFC

Treatment:

Drug: recFSH