Urofollitrophin
DrugOther names: human derived follicle stimulation hormone
NCT Number: NCT01969201
The purpose of the non-inferiority study is to evaluate the clinical efficacy and the safety of two different subcutaneous FSH preparations (Fostimon versus Gonal-F) for controlled ovarian hyperstimulation in a GnRH-antagonist cycle.
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Notify Me18 year–38 year
Female
Interventional
Phase 4
UCL- Cliniques Universitaires Saint Luc, Brussels, Belgium
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Other names: human derived follicle stimulation hormone
Other names: Recombinant follicle stimulation hormone
Time frame: 8 weeks
A clinical pregnancy is defined as a pregnancy showing ultrasound embryonic heart activity at 8 weeks of gestation;
Time frame: 10-15 days after starting FSH stimulation
Time frame: end of treatment period, approximately 2 - 3 weeks.
Time frame: end of treatment period, approximately 2 - 3 weeks
Time frame: On culture day 3
The embryo quality evaluation will be performed on culture day 3, just before embryo transfer and will consist in the assessment of blastomeres number and 2 embryo morphology parameters: degree of fragmentation and cell division aspect.
Time frame: 2 weeks after embryo transfer
Two weeks after embryo transfer, a serum pregnancy test will be performed.
Time frame: 9 months
Time frame: 2 years
Patients who will not get pregnant during the study, will be allowed to perform a frozen embryo transfer. Cumulative pregnancy rate will include also pregnancies achieved after a frozen embryo transfer.
IBSA Institut Biochimique SA
Industry
Randomised Clinical Trial Comparing Highly Purified FSH Formulation (Fostimon®) and Recombinant FSH (Gonal-F®) in GnRH-antagonist Controlled Ovarian Hyperstimulation Cycles.
Acronym: FAST
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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