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

Phase 4

Completed

• Conditions: Infertility
• Interventions: Drug: FSH

• Registration Number: NCT01783301
• Lead Sponsor: Vietnam National University

Brief Summary

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.

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 Timeline

• Study Start: 2011-10
• Primary Completion: 2012-08
• Study Completion: 2012-12
• Status Verified: 2013-01
• Study First Submitted: 2013-01-17
• Study First Submitted QC: 2013-01-31
• Last Update Submitted: 2013-01-31
• Study First Posted: 2013-02-04
• Last Update Posted: 2013-02-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 348

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Antral follicle count	FSH	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
Anti-Mullerian Hormone	FSH	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

Primary Outcome Measures

Name	Time	Method
Number of oocytes retrieved	30 minutes after oocyte retrieval completed

Secondary Outcome Measures

Name	Time	Method
Symptoms of ovarian hyperstimulation syndrome (OHSS)	in 10 days after hCG injection

Trial Locations

Locations (1)

Research Center for Genetics and Reproductive Health; 🇻🇳 Ho Chi Minh, Vietnam