Sterility Clinical Trial
Official title:
Prospective, Randomized Open Trial to Evaluate the Efficacy of an Ovarian Stimulation Protocol Based on FSH Receptor Genotype
Verified date | May 2015 |
Source | Medical University of Vienna |
Contact | n/a |
Is FDA regulated | No |
Health authority | Austria: Federal Ministry for Health and Women |
Study type | Interventional |
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).
Status | Suspended |
Enrollment | 165 |
Est. completion date | June 2015 |
Est. primary completion date | May 2015 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years to 40 Years |
Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Austria | University of Vienna | Vienna |
Lead Sponsor | Collaborator |
---|---|
Medical University of Vienna |
Austria,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | clinical pregnancy rate | 3 months | No | |
Secondary | follicle count, cycle cancellation rate, poor responder rate | 2 months | No |
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