Tailored Ovarian Stimulation Based on BMI, AMH, AFC

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

Status

UNKNOWN

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02430740

Enrollment

300

Registered

2015-04-30

Start date

2016-01-31

Completion date

2023-12-31

Last updated

2023-04-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Infertility

Keywords

Fertilization in Vitro, antagonist protocol, antral follicle count, Anti-Mullerian Hormone, Reproductive Techniques, Assisted

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.

Interventions

DRUGrecFSH

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to 43 Years

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

Design outcomes

Primary

Measure	Time frame
number of mature follicles	2 years
number of oocytes retrieved	2 years
rec FSH dose used	2 years

Secondary

Measure	Time frame
AMH level during stimulation	2 years
fertilization rate	2 years
Inhibin B level during stimulation	2 years
cleavage rate	2 years
clinical pregnancy rate	2 years

Countries

Belgium

Contacts

Primary ContactChristine Wyns, MD, PhD

christine.wyns@uclouvain.be003227649501

Backup ContactCéline Pirard, Md, PhD

celine.pirard@uclouvain.be003227644116

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026