Anti-Mullerian Hormone (AMH) Versus Antral Follicle Count (AFC) Guided rFSH Dosing Study

A Phase IV, Open-label 2 Arm Trial to Compare the Efficacy and Safety of a Pre-defined Dose of GONAL-f® Based on Antral Follicle Count [Follicles ≥2mm - <11mm]), or AMH for Ovarian Stimulation in Subjects Undergoing Assisted Reproductive Technology (ART) Treatment.

The overall objectives of this trial are to:

• To explore the efficacy and safety of using either antral follicle count (AFC) or anti-Mullerian hormone (AMH) to guide the starting dose of GONAL-f® in ovarian stimulation for Assisted Reproductive Technology (ART).
• To assess the differences in both ovarian response and clinical pregnancy rate between subjects with different AFC and AMH levels undergoing ART.

Study Overview

• Status: Completed
• Conditions: Infertility
• Intervention / Treatment: Drug: FSH

Detailed Description

Trial design

This trial is a prospective, Phase IV 2 arm trial exploring the efficacy and safety of using either AFC or AMH to guide the starting GONAL-f® dose for the stimulation treatment of subjects undergoing ART.

Throughout the trial period and before the start of a routine ART cycle, investigators will propose the trial to their potential subjects. All subjects who agree to participate in the trial must sign a consent form, irrespective of whether or not they ultimately agree to have their dose determined by the study protocol. Eligible subjects will be randomised in blocks of 4 at each site via a computer generated random number list to either the AFC guided arm (control) or the AMH guided arm (treatment). The starting doses of GONAL-f® for each arm will be based on the study algorithms, using AFC or AMH guidance.

The investigator will then enter initiate ovarian stimulation with an individualised GONAL-f® dose for that specific subject. This will be maintained for the first 5 days of stimulation after which the dose can be modified based on investigator decision and in accordance with the site's routine clinical practice.

Trial Population

Female partners of infertile couples requiring Assisted Reproductive Technology (ART) treatment.

Data Analysis and Statistics

The primary end-point proportion of patients with desired number of retrieved oocytes (8-12) will be compared between the 2 arms using the chi -square test. The null hypothesis will be that there is no difference between the 2 arms in primary end-point, with the p level set at p=0.05. The secondary end-points will also be compared between the 2 arms using either the Student's t test or anova test.

• Study Type: Interventional
• Enrollment (Actual): 348
• Phase: Phase 4

Contacts and Locations

Study Locations

• Vietnam
  • Ho Chi Minh, Vietnam
    • Research Center for Genetics and Reproductive Health

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 43 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

• Starting a treatment with GONAL-f® according to the decision of the investigator and in accordance with the indication and dosing recommendation
• Age < 40 years at the time of GONAL-f® dosing
• BMI < 28 kg/m2
• An early follicular phase (Day 2-4) serum levels of basal FSH ≤12 IU/L measured in the site's own laboratory and taken within 2 months prior to down-regulation start
• Receiving long Gonadotropin-Releasing Hormone (GnRH) agonist protocol (starting on day 21 of preceding cycle until day of hCG)
• Agreement to participate in the study, and to disclose any medical events to the investigator. The subject must be willing and able to comply with the protocol requirements for the duration of the study.
• Have given written informed consent with the understanding that the subject may withdraw consent at any time without prejudice to future medical care.

Exclusion Criteria:

• Simultaneous participation in an interventional clinical trial.
• Concommitant use of either Luteinizing Hormone or human menopausal gonadotropin/urinary FSH preparations in study cycle

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Antral follicle count; Start dose of recombinant Follicle-Stimulating Hormone (rFSH) based on AFC guide; AFC < 6 on both ovary: 375 IU FSH; 6<AFC <=15 on both ovary: 225 IU FSH; AFC> 15 on both ovary: 150 IU FSH	Drug: FSH; Other Names: GONAL-f
Active Comparator: Anti-Mullerian Hormone; Start dose of FSH based on AMH guide; AMH < 5 pmol/L or < 0.7ng/ml: 375 IU FSH; AMH 5 to < 15 pmol/L or 0.7 to 2.1ng/ml: 225 IU FSH; AMH ≥ 15 pmol/L or > 2.1ng/ml: 150 IU FSH	Drug: FSH; Other Names: GONAL-f

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Number of oocytes retrieved	30 minutes after oocyte retrieval completed

Secondary Outcome Measures

Outcome Measure	Time Frame
Symptoms of ovarian hyperstimulation syndrome (OHSS)	in 10 days after hCG injection

Collaborators and Investigators

• Sponsor: Vietnam National University
• Collaborators: Merck Serono Vietnam
• Investigators: Principal Investigator: Tuong M Ho, MD, Vietnam National University HCMC

Study record dates

Study Major Dates

• Study Start: October 1, 2011
• Primary Completion (Actual): August 1, 2012
• Study Completion (Actual): December 1, 2012

Study Registration Dates

• First Submitted: January 17, 2013
• First Submitted That Met QC Criteria: January 31, 2013
• First Posted (Estimate): February 4, 2013

Study Record Updates

• Last Update Posted (Estimate): February 4, 2013
• Last Update Submitted That Met QC Criteria: January 31, 2013
• Last Verified: January 1, 2013

More Information

Terms related to this study

• Keywords: follicle stimulating hormone; ovarian stimulation; antimullerian hormone; antral follicle count; assisted reproductive technologies
• Additional Relevant MeSH Terms: Infertility
• Other Study ID Numbers: 11/QD-CGRH-NCKH&DT