Tailored Ovarian Stimulation Based on BMI, AMH, AFC

Last updated: April 11, 2023
Sponsor: Cliniques universitaires Saint-Luc- Université Catholique de Louvain
Overall Status: Active - Recruiting

Phase

4

Condition

Infertility

Treatment

N/A

Clinical Study ID

NCT02430740
AMH1
  • Ages 18-43
  • Female

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • female infertile patients eligible for IVF treatment

Exclusion

Exclusion Criteria:

  • polycystic ovaries
  • untreated thyroid pathology
  • hypogonadotropic hypogonadism
  • untreaed hyperprolactinemia
  • study drug hypersensitivity
  • previous OHSS
  • unilateral ovariectomy
  • genital malformation
  • BMI>40

Study Design

Total Participants: 300
Study Start date:
January 01, 2016
Estimated Completion Date:
December 31, 2023

Study 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.

Connect with a study center

  • Cliniques universitaires Saint Luc

    Brussels, 1200
    Belgium

    Active - Recruiting

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