Clincosm LogoSign in Get a demo

Tailored Ovarian Stimulation Based on BMI, AMH, AFC

Sponsor
Cliniques universitaires Saint-Luc- Université Catholique de Louvain (Other)
Overall Status
Recruiting
CT.gov ID
NCT02430740
Collaborator
(none)
300
Enrollment
1
Location
2
Arms
65
Anticipated Duration (Months)
4.6
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
Phase 4

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
300 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Multicentric Randomized Controlled Study to Determine a Tailored Strategy for Controlled Ovarian Stimulation in IVF Based on AMH, BMI and AFC
Actual Study Start Date :
Jan 1, 2016
Anticipated Primary Completion Date :
Jun 1, 2021
Anticipated Study Completion Date :
Jun 1, 2021

Arms and Interventions

Arm Intervention/Treatment
Other: control group

standard care recFSH

Drug: recFSH
Other Names:
  • Gonal F
  • Puregon
  • Fostimon

    		•
    Experimental: study group

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

    Drug: recFSH
    Other Names:
  • Gonal F
  • Puregon
  • Fostimon

    		•

    Outcome Measures

    Primary Outcome Measures

    1. number of mature follicles [2 years]

    2. number of oocytes retrieved [2 years]

    3. rec FSH dose used [2 years]

    Secondary Outcome Measures

    1. fertilization rate [2 years]

    2. cleavage rate [2 years]

    3. clinical pregnancy rate [2 years]

    4. AMH level during stimulation [2 years]

    5. Inhibin B level during stimulation [2 years]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 43 Years
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Cliniques universitaires Saint Luc Brussels Belgium 1200

    Sponsors and Collaborators

    • Cliniques universitaires Saint-Luc- Université Catholique de Louvain

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Wyns, MD, PhD, Cliniques universitaires Saint-Luc- Université Catholique de Louvain
    ClinicalTrials.gov Identifier:
    NCT02430740
    Other Study ID Numbers:
    • AMH1
    First Posted:
    Apr 30, 2015
    Last Update Posted:
    Oct 22, 2020
    Last Verified:
    Oct 1, 2020
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Keywords provided by Wyns, MD, PhD, Cliniques universitaires Saint-Luc- Université Catholique de Louvain
    Fertilization in Vitro
    antagonist protocol
    antral follicle count
    Anti-Mullerian Hormone
    Reproductive Techniques, Assisted
    Additional relevant MeSH terms:
    Infertility

    Study Results

    No Results Posted as of Oct 22, 2020