Multi-centre Study to Compare Efficacy and Safety of AFOLIA and Gonal-f in Women for Assisted Reproductive Treatment

Finox

Status and phase

Completed

Phase 3

Conditions

Infertility

Treatments

Drug: Follitropin alfa

Study type

Interventional

Funder types

Industry

Identifiers

NCT01121666

FIN3001

2010-019287-37 (EudraCT Number)

Details and patient eligibility

About

Ther 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.

Enrollment

460 patients

Sex

Female

Ages

20 to 38 years old

Volunteers

No Healthy Volunteers

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