Tailored Ovarian Stimulation Based on BMI, AMH, AFC

Infertility Clinical Trial

Official title: Multicentric Randomized Controlled Study to Determine a Tailored Strategy for Controlled Ovarian Stimulation in IVF Based on AMH, BMI and AFC

Status Recruiting

Clinical Trial 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.

Clinical Trial 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. ;

Related Conditions & MeSH terms

• Infertility

• NCT number: NCT02430740
• Study type: Interventional
• Source: Cliniques universitaires Saint-Luc- Université Catholique de Louvain
• Contact: Christine Wyns, MD, PhD
• Phone: 003227649501
• Email: christine.wyns@uclouvain.be
• Status: Recruiting
• Phase: Phase 4
• Start date: January 2016
• Completion date: December 2023