Efficacy of Ovarian Stimulation Based on FSHR Genotype Status

• Status: Suspended
• Trial end date: 2015-06-01
• Target enrollment: 0
• Participant gender: Female

Summary

Available data from in vitro studies and clinical trials indicate that genetic factors play a significant role in the success of controlled ovarian stimulation (COS) prior to in vitro fertilization - embryo trandfer (IVF-ET). Women with the FSHR Ser680Asn Ser/Ser genotype make up between 13% and 26% of women undergoing IVF-ET and are characterised by higher basal FSH serum concentrations, the need for a higher amount of FSH for COS, and a higher risk of poor response to COS and cycle cancellation.

The investigators therefore intend to perform a study to investigate whether a dose-intensified COS protocol based on FSHR genotype status in women with the FSHR Ser680Asn Ser/Ser genotype is more effective than routine management in terms of

• the mean number of follicles

• the mean number of embryos

• the rate of poor responders

• the rate of women with cycle cancellations, and v) the clinical pregnancy rates.

Eligible women will be randomized to a stimulation protocol characterised by a longer duration and increased dosage of FSH stimulation (group A) or a standard stimulation protocol (group B).

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Medical University of Vienna
• Treatments: Buserelin; Follicle Stimulating Hormone; Hormones

Criteria

Inclusion Criteria:

• Age between 18 and 40

• Informed consent

• Indication for IVF-ET

Exclusion Criteria:

• Inability to understand written informed consent form

• Personal history of ovarian hyperstimulation syndrome