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

• Status: Completed
• Trial end date: 2012-12-01
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Vietnam National University
• Collaborator: Merck Serono Vietnam
• Treatments: Follicle Stimulating Hormone; Hormones

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