couple infertility MedDRA version: 9.1 Level: SOC Classification code 10038604 Term: Reproductive system and breast disorders
Conditions
Interventions
Trade Name: GONAL F
Pharmaceutical Form: Solution for injection
INN or Proposed INN: Follitropin alfa
Concentration unit: IU international unit(s)
Concentration type: equal
Concentration number: 150-
Sponsors
AZIENDA OSPEDALIERA UNIVERSITARIA CAREGGI
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: severe male factor Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: female: age > 38; reduced ovarian reserve; endometriosis male: chromosomical and/or genic anomalies
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: decrease of aneuploidic rate by treatment;Secondary Objective: 1. increase of seminal parameters 2. increase of pregnancy rate;Primary end point(s): decrease of aneuploidic rate by treatment | — |
Countries
Italy
Outcome results
None listed