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

NCT01783301 | Completed Phase 4

• 1 other identifier: 11/QD-CGRH-NCKH&DT
• Study Type: interventional
• Target: 348
• Locations: 1 country
• Sites: 1

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.

Conditions

Infertility

Keywords

follicle stimulating hormone; ovarian stimulation; antimullerian hormone; antral follicle count; assisted reproductive technologies

Outcome Measures

Primary Outcomes (1)

• Number of oocytes retrieved

  30 minutes after oocyte retrieval completed

Secondary Outcomes (1)

• Symptoms of ovarian hyperstimulation syndrome (OHSS)

  in 10 days after hCG injection

Study Arms (2)

Antral follicle count

ACTIVE COMPARATOR

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

Anti-Mullerian Hormone

ACTIVE COMPARATOR

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

Interventions

FSH DRUG

Also known as: GONAL-f

Anti-Mullerian Hormone; Antral follicle count

Eligibility Criteria

• Age: 20 Years - 45 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Vietnam National University: lead
• Merck Serono Vietnam: collaborator

Study Sites (1)

Research Center for Genetics and Reproductive Health

Ho Chi Minh City, Ho Chi Minh, Vietnam

Location

MeSH Terms

Conditions

Infertility

Interventions

follitropin alfa

Condition Hierarchy (Ancestors)

Genital Diseases; Urogenital Diseases

Study Officials

• Tuong M Ho, MD

  Vietnam National University HCMC

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr

Study Record Dates

• First Submitted: January 17, 2013
• First Posted: February 4, 2013
• Study Start: October 1, 2011
• Primary Completion: August 1, 2012
• Study Completion: December 1, 2012
• Last Updated: February 4, 2013

Record last verified: 2013-01

Locations

VN (1)