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Tailored Ovarian Stimulation Based on BMI, AMH, AFC

Primary Purpose

Infertility

Status
Recruiting
Phase
Phase 4
Locations
Belgium
Study Type
Interventional
Intervention
recFSH
Sponsored by
Cliniques universitaires Saint-Luc- Université Catholique de Louvain
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Infertility focused on measuring Fertilization in Vitro, antagonist protocol, antral follicle count, Anti-Mullerian Hormone, Reproductive Techniques, Assisted

Eligibility Criteria

18 Years - 43 Years (Adult)FemaleDoes not accept 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

Sites / Locations

  • Cliniques universitaires Saint LucRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Experimental

Arm Label

control group

study group

Arm Description

standard care recFSH

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

Outcomes

Primary Outcome Measures

number of mature follicles
number of oocytes retrieved
rec FSH dose used

Secondary Outcome Measures

fertilization rate
cleavage rate
clinical pregnancy rate
AMH level during stimulation
Inhibin B level during stimulation

Full Information

First Posted
April 27, 2015
Last Updated
April 11, 2023
Sponsor
Cliniques universitaires Saint-Luc- Université Catholique de Louvain
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1. Study Identification

Unique Protocol Identification Number
NCT02430740
Brief Title
Tailored Ovarian Stimulation Based on BMI, AMH, AFC
Official Title
Multicentric Randomized Controlled Study to Determine a Tailored Strategy for Controlled Ovarian Stimulation in IVF Based on AMH, BMI and AFC
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 2016 (Actual)
Primary Completion Date
December 2023 (Anticipated)
Study Completion Date
December 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cliniques universitaires Saint-Luc- Université Catholique de Louvain

4. Oversight

Data Monitoring Committee
No

5. 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: control group: standard care rec FSH. 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: control group: standard care recFSH based on age, basal FSH and AFC. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infertility
Keywords
Fertilization in Vitro, antagonist protocol, antral follicle count, Anti-Mullerian Hormone, Reproductive Techniques, Assisted

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
300 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
control group
Arm Type
Other
Arm Description
standard care recFSH
Arm Title
study group
Arm Type
Experimental
Arm Description
modified dosage of recFSH for controlled ovarian stimulation based on AMH, BMI and AFC
Intervention Type
Drug
Intervention Name(s)
recFSH
Other Intervention Name(s)
Gonal F, Puregon, Fostimon
Primary Outcome Measure Information:
Title
number of mature follicles
Time Frame
2 years
Title
number of oocytes retrieved
Time Frame
2 years
Title
rec FSH dose used
Time Frame
2 years
Secondary Outcome Measure Information:
Title
fertilization rate
Time Frame
2 years
Title
cleavage rate
Time Frame
2 years
Title
clinical pregnancy rate
Time Frame
2 years
Title
AMH level during stimulation
Time Frame
2 years
Title
Inhibin B level during stimulation
Time Frame
2 years

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
43 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Christine Wyns, MD, PhD
Phone
003227649501
Email
christine.wyns@uclouvain.be
First Name & Middle Initial & Last Name or Official Title & Degree
Céline Pirard, Md, PhD
Phone
003227644116
Email
celine.pirard@uclouvain.be
Facility Information:
Facility Name
Cliniques universitaires Saint Luc
City
Brussels
ZIP/Postal Code
1200
Country
Belgium
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Christine Wyns, MD, PhD
Phone
003227649501
Email
christine.wyns@uclouvain.be
First Name & Middle Initial & Last Name & Degree
Céline Pirard, Md, PhD
Phone
003227649501
Email
celine.pirard@uclouvain.be

12. IPD Sharing Statement

Plan to Share IPD
No

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Tailored Ovarian Stimulation Based on BMI, AMH, AFC

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