Tailored Ovarian Stimulation Based on BMI, AMH, AFC

April 11, 2023 updated by: Wyns, Cliniques universitaires Saint-Luc- Université Catholique de Louvain

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

300

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 43 years (Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: control group
standard care recFSH
Drug: recFSH
Other Names:
  • Puregon
  • Fostimon
  • Gonal F
Experimental: study group
modified dosage of recFSH for controlled ovarian stimulation based on AMH, BMI and AFC
Drug: recFSH
Other Names:
  • Puregon
  • Fostimon
  • Gonal F

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
number of oocytes retrieved
Time Frame: 2 years
2 years
number of mature follicles
Time Frame: 2 years
2 years
rec FSH dose used
Time Frame: 2 years
2 years

Secondary Outcome Measures

Outcome Measure
Time Frame
clinical pregnancy rate
Time Frame: 2 years
2 years
fertilization rate
Time Frame: 2 years
2 years
cleavage rate
Time Frame: 2 years
2 years
AMH level during stimulation
Time Frame: 2 years
2 years
Inhibin B level during stimulation
Time Frame: 2 years
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cliniques universitaires Saint-Luc- Université Catholique de Louvain

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2016

Primary Completion (Anticipated)

December 1, 2023

Study Completion (Anticipated)

December 1, 2023

Study Registration Dates

First Submitted

April 27, 2015

First Submitted That Met QC Criteria

April 29, 2015

First Posted (Estimate)

April 30, 2015

Study Record Updates

Last Update Posted (Actual)

April 12, 2023

Last Update Submitted That Met QC Criteria

April 11, 2023

Last Verified

April 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AMH1

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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