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

NCT ID: NCT01121666

Last Updated: 2016-04-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 460 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-06-30
• Study Completion Date: 2013-03-31

Brief 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.

Conditions

Infertility

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Gonal-f® (Follitropin alfa)

Group Type: ACTIVE_COMPARATOR

Follitropin alfa

Intervention Type: DRUG

150IU per day subcutaneously for a maximum of 16 days

AFOLIA-150 (Follitropin alfa)

Group Type: EXPERIMENTAL

Follitropin alfa

Intervention Type: DRUG

150IU per day subcutaneously for a maximum of 16 days

Interventions

Follitropin alfa

150IU per day subcutaneously for a maximum of 16 days

Intervention Type: DRUG

Eligibility 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

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 38 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Finox AG

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Bruno Imthurn

Role: PRINCIPAL_INVESTIGATOR

University of Zurich

Locations

Kinderwunsch Institut Schenk GmbH

Graz, , Austria

Landes-Frauenklinik und Kinderklinik Linz

Linz, , Austria

AKH Vienna

Vienna, , Austria

IVF Zentrum Döbling

Vienna, , Austria

Privatspital Goldenes Kreuz

Vienna, , Austria

Fertility Clinic

Copenhagen, , Denmark

Copenhagen Fertility Center

Copenhagen, , Denmark

Dansk Fertilitetsklinik

Frederiksberg, , Denmark

Universitätsklinikum Bonn

Bonn, , Germany

Universitäts-Frauenklinik

Heidelberg, , Germany

Institut Universitari Dexeus

Barcelona, , Spain

IVI Madrid

Madrid, , Spain

University Hospital of Zurich

Zurich, , Switzerland

Guy's and St Thomas' NHS Foundation Trust

London, , United Kingdom

Kings College Hospital

London, , United Kingdom

St Barthlomew's Hospital

London, , United Kingdom

Countries

Austria; Denmark; Germany; Spain; Switzerland; United Kingdom

Other Identifiers

2010-019287-37

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

FIN3001

Identifier Type: -

Identifier Source: org_study_id