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

This study has been completed.
Sponsor:
Collaborator:
Merck Serono Vietnam
Information provided by (Responsible Party):
Manh Tuong Ho, Vietnam National University
ClinicalTrials.gov Identifier:
NCT01783301
First received: January 17, 2013
Last updated: January 31, 2013
Last verified: January 2013
  Purpose

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.

Condition Intervention Phase
Infertility
Drug: FSH
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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.

Resource links provided by NLM:


Further study details as provided by Vietnam National University:

Primary Outcome Measures:
  • Number of oocytes retrieved [ Time Frame: 30 minutes after oocyte retrieval completed ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Symptoms of ovarian hyperstimulation syndrome (OHSS) [ Time Frame: in 10 days after hCG injection ] [ Designated as safety issue: Yes ]

Enrollment: 348
Study Start Date: October 2011
Study Completion Date: December 2012
Primary Completion Date: August 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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 Name: GONAL-f

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.

  Eligibility

Ages Eligible for Study:   20 Years to 45 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01783301

Locations
Vietnam
Research Center for Genetics and Reproductive Health
Ho Chi Minh, Vietnam
Sponsors and Collaborators
Vietnam National University
Merck Serono Vietnam
Investigators
Principal Investigator: Tuong M Ho, MD Vietnam National University HCMC
  More Information

No publications provided

Responsible Party: Manh Tuong Ho, Dr, Vietnam National University
ClinicalTrials.gov Identifier: NCT01783301     History of Changes
Other Study ID Numbers: 11/QD-CGRH-NCKH&DT
Study First Received: January 17, 2013
Last Updated: January 31, 2013
Health Authority: Vietnam: Vietnam National University HCMC

Keywords provided by Vietnam National University:
follicle stimulating hormone
ovarian stimulation
antimullerian hormone
antral follicle count
assisted reproductive technologies

Additional relevant MeSH terms:
Infertility
Genital Diseases, Male
Genital Diseases, Female
Hormones
Follicle Stimulating Hormone
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on August 28, 2014