Title
Multi-centre Study to Compare Efficacy and Safety of AFOLIA and Gonal-f in Women for Assisted Reproductive Treatment
A Phase III Assessor-blinded Randomized Parallel Group Multi-centre Study to Compare Efficacy and Safety of Two r-hFSH Formulations (AFOLIA Versus Gonal-f) in Women for Assisted Reproductive Treatment
Phase
Phase 3Lead Sponsor
Finox AGStudy Type
InterventionalStatus
Completed Results PostedIndication/Condition
InfertilityIntervention/Treatment
follitropin alfa ...Study Participants
460Ther purpose of this study is to show equivalence between AFOLIA and Gonal-f® with regard to the number of oocytes retrieved in women for assisted reproductive treatment.
150IU per day subcutaneously for a maximum of 16 days
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 < 10 IU/L (cycle day 2-5) E2 levels < 50pg/mL (< 0.18 nmol/L) at the day of FSH administration Antral follicle count (AFC) ≥ 10 to ≤ 25 follicles (sum of both ovaries) Infertility due to any of the following factors: tubal factor, mild endometriosis (ASRM stage 1-2), male factor, unexplained infertility Presence of both ovaries and normal uterine cavity (confirmed by transvaginal ultrasound within 6 months before randomisation) Willingness to participate in the study and to comply with the study protocol Informed consent Exclusion Criteria: Presence of pregnancy History of ≥2 succeeding ART cycles (IVF and/or ICSI) before the study cycle without clinical pregnancy 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 tumors of the hypothalamus and pituitary gland Abnormal bleeding of undetermined origin 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 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, vitrelle®, and Utrogestan®) Presence or history of thrombophlebitis or thromboembolic disorders Presence or history of cerebral haemorrhage Presence or history of porphyria
| Event Type | Organ System | Event Term | AFOLIA-150 (Follitropin Alfa) | Gonal-f® (Follitropin Alfa) |
|---|
As soon as ovulation criteria were reached, HCG was given to trigger ovulation and 34-36 hours later, oocytes were retrieved. If criteria for ovulation triggering could not be reached by FSH stimulation on day 16, treatment was to be stopped. The equivalence in the number of retrieved oocytes was tested using a pre-determined clinical equivalence margin of +/- 2.9 oocytes
As soon as ovulation criteria were reached, HCG was given to trigger ovulation and 34-36 hours later, oocytes were retrieved. If criteria for ovulation triggering could not be reached by FSH stimulation on day 16, treatment was to be stopped. The equivalence in the number of retrieved oocytes was tested using a pre-determined clinical equivalence margin of +/- 2.9 oocytes
The serum concentration of oestradiol was assessed at day 8 and the day of hCG administration.
Total dose of r-hFSH required was assessed.
Number of patients with ovum pick-up
Fertilisation rate was assessed
Main embryo quality parameter "mean number of blastomeres"
Mean duration of stimulation was assessed.
Number of patients with cycle cancellation was assessed.
Good response was defined as "patients with an oocyte retrieval of four or more oocytes"
Defined as fetal sac per embryo transferred.
Presence of at least one intrauterine gestational sac.
Ongoing pregnancy per embryo transfer. Presence of at least one viable fetus 10 weeks after embryo transfer.
Patients with liveborn children
Main embryo quality parameter "absence of multinucleation" observed.
Number of patients with transferred blastocysts
Number of embryos per blastocysts transferred
Presence of at least one intrauterine gestational sac.
Ongoing pregnancy per embryo transfer. Presence of at least one viable fetus 10 weeks after embryo transfer.
The maturity of the cumulus oophorus was assessed.
The nuclear maturity was assessed (Germinal vesicle, Metaphase I, Metaphase II).
The number and size of follicles 12 mm or over in diameter at day 8 of stimulation were evaluated as secondary end-point.
