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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
710
UCL- Cliniques Universitaires Saint Luc
Brussels, Belgium
Universitair Ziekenhuis Brussel
Brussels, Belgium
Spedali Civili di Brescia
Brescia, Italy
Clinical Pregnancy Rate
A clinical pregnancy is defined as a pregnancy showing ultrasound embryonic heart activity at 8 weeks of gestation;
Time frame: 8 weeks
Number of Follicles >16 mm on the Day of hCG Injection
Time frame: 10-15 days after starting FSH stimulation
Total Number of Oocytes Retrieved
Time frame: end of treatment period, approximately 2 - 3 weeks.
Fertilization Rate
Time frame: end of treatment period, approximately 2 - 3 weeks
Embryo Quality (Number of Top Quality Embryos Transferred Per Patient)
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: On culture day 3
Positive Serum Pregnancy Test Rate
Two weeks after embryo transfer, a serum pregnancy test will be performed.
Time frame: 2 weeks after embryo transfer
Delivery Rate
Time frame: 9 months
Cumulative Pregnancy Rate
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.
Time frame: 2 years
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Fondazione Ca'Granda, Osp Maggiore Policlinico
Milan, Italy
IRCCS San Raffaele
Milan, Italy
Università degli Studi di Napoli 'Federico II'
Naples, Italy
Azienda Ospedaliera Di Reggio Emilia
Reggio Emilia, Italy
Clinica IVI Alicante
Alicante, Spain
Institut Universitari Dexeus
Barcelona, Spain
Ginefiv Clínica de Fertilidad
Madrid, Spain
...and 6 more locations