Overview

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