Female sterility MedDRA version: 14.1 Level: LLT Classification code 10016422 Term: Female sterility System Organ Class: 10038604 - Reproductive system and breast disorders
Conditions
Interventions
Trade Name: PERGOVERIS
Pharmaceutical Form: Powder and solvent for solution for injection
Concentration unit: IU international unit(s)
Concentration number: 150-
Trade Name: GONAL F 150
Pharmaceutica
Sponsors
CASA DI CURA ABANO TERME POLISPECIALISTICA E TERMALE
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - infertile patients aged 35 to 43 years inclusive; - regular cycles of 26-33 days; - tubal or male sterility; - idiopathic sterility only if exceeding 2 years; - no ovarian stimulation of any kind during the previous 3 months; - FSH on 3rd day >10 and =65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: - infertile patients aged up to 34 and >= 44 years; - hypo-hypo patients; - participation in another clinical trial within the past 30 days; - known hypersensitivity to the trial treatment, or the comparator drug; - legal incapacity or limited legal capacity; - any clinically important systemic disease (e.g. insulin-dependent diabetes mellitus, epilepsy, serious migraine, intermittent purpura, hepatic, renal or cardiovascular disease, serious corticoid-dependent asthma) wich constitutes a controindication to gonadotropin use.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To establish if Pergoveris can improve number of oocytes retrieved in a predefined poor responder ART patient population.;Secondary Objective: See Main objective;Primary end point(s): Number of oocytes retrieved. | — |
Countries
Italy
Outcome results
None listed