Stimulation of multifollicular develoment in patients undergoing assisted reproductivet treatment
Conditions
Interventions
Product Name: AFOLIA
Product Code: not applicable
Pharmaceutical Form: Solution for injection
INN or Proposed INN: Follitropin alfa
CAS Number: n.a.
Current Sponsor code: human follicle stimulating h
Sponsors
Finox AG
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: ? Age between 20 and 38 years with regular menstrual cycles of 25-35 days ? First or second cycle in the present series of ART ? BMI = 18 = 30 kg/m2 ? Basal FSH =65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: ? Presence of pregnancy ? History of =2 succeeding ART cycles (which includes fresh and frozen embryo transfers) before the study cycle without clinical pregnancy (applies only for first treatment cycle) ? Presence of clinically significant systemic disease ? Presence of chronic cardiovascular, hepatic, renal or pulmonary disease ? Presence of uncontrolled endocrine disorder ? Previous history or presence of severe ovarian hyperstimulation syndrome ? Presence of polycystic ovaries (PCO) ? Presence of severe endometriosis (ASRM stage 3 or stage 4) and hydrosalpinx ? Neoplasia, including tumours of the hypothalamus and pituitary gland ? Abnormal bleeding of undetermined origin ? History of extrauterine pregnancy in the previous 3 months ? Known allergy or hypersensitivity to progesterone or to any of the excipients (including peanut oil) of the additional study medication (GnRH agonist, Ovitrelle®, and Utrogestan®) ? Presence or history of thrombophlebitis or thromboembolic disorders ? Presence or history of cerebral haemorrhage ? Presence or history of porphyria ? History of poor response to gonadotropin treatment (defined as fewer than 5 oocytes retrieved in a previous attempt) ? Male infertility without mobile spermatozoa in the ejaculate, that need testicular of epididymal sperm retrieval (MESA/TESE/TESA) ? Endocrine abnormality such as TSH or prolactin level elevations outside the reference range if clinically relevant at screening ? Any hormonal treatment within 1 month before the start of the FSH treatment (with the exception of levothyroxin) ? History of drug, nicotine or alcohol abuse within the last 12 months (> 10 cigarettes/day) ? Administration of other investigational products within the last month ? Clinically abnormal findings at Visit 1 ? Planned PGS/PGD/PBB or assisted hatching ? Concomitant participation in an other study protocol
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To show equivalence between AFOLIA and Gonal-f®;Secondary Objective: To compare therapy related outcomes and safety between AFOLIA and Gonal-f®;Primary end point(s): To compare the number of oocytes retrieved from patients undergoing ART treatment with AFOLIA versus Gonal-f® | — |
Countries
Austria, Denmark, Germany, Spain, United Kingdom
Outcome results
None listed