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

• Status: Completed
• Trial end date: 2013-03-01
• Target enrollment: 0
• Participant gender: Female

Summary

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Finox AG
• Treatments: Follicle Stimulating Hormone

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 < 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