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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02430740
• Other study ID #: AMH1
• Status: Recruiting
• Phase: Phase 4
• Start date: January 2016
• Est. completion date: December 2023

Study information

• Verified date: April 2023
• Source: Cliniques universitaires Saint-Luc- Université Catholique de Louvain
• Contact: Christine Wyns, MD, PhD
• Phone: 003227649501
• Email: christine.wyns[@]uclouvain.be
• Is FDA regulated: No
• Study type: Interventional

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.

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 information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: December 2023
• Est. primary completion date: December 2023
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 43 Years

Eligibility

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

Related Conditions & MeSH terms

• Infertility

Intervention

Drug:
• recFSH

Locations

Country	Name	City	State
Belgium	Cliniques universitaires Saint Luc	Brussels

Sponsors (1)

Lead Sponsor	Collaborator
Cliniques universitaires Saint-Luc- Université Catholique de Louvain

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	number of mature follicles		2 years
Primary	number of oocytes retrieved		2 years
Primary	rec FSH dose used		2 years
Secondary	fertilization rate		2 years
Secondary	cleavage rate		2 years
Secondary	clinical pregnancy rate		2 years
Secondary	AMH level during stimulation		2 years
Secondary	Inhibin B level during stimulation		2 years