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

Purpose

Ther purpose of this study is to show equivalence with regard to the number of oocytes retrieved between AFOLIA and Gonal-f® in women for assisted reproductive treatment

Condition	Intervention	Phase
Infertility	Drug: Follitropin alfa	Phase 3

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Bio-equivalence Study Intervention Model: Parallel Assignment Masking: Single Blind (Outcomes Assessor) Primary Purpose: Treatment
Official Title:	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

Resource links provided by NLM:

MedlinePlus related topics: Infertility

U.S. FDA Resources

Further study details as provided by Finox AG:

Primary Outcome Measures:

Number of oocytes retrieved [ Time Frame: At the day of hCG administration but not longer than 16 days after start of treatment with r-hFSH ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Number and size of follicles ≥ 12 mm at day 8 of stimulation and number and size of follicles ≥ 12 mm at the day of hCG administration [ Time Frame: Day 8 of stimulation and at the day of hCG administration but not longer than 16 days ] [ Designated as safety issue: No ]
E2 concentration at day 8 and at day of hCG administration [ Time Frame: Day 8 of stimulation and at the day of hCG administration but not longer than 16 days ] [ Designated as safety issue: No ]
Trough level of FSH after repeated administration of r-hFSH [ Time Frame: Day 8 of stimulation and at the day of hCG administration but not longer than 16 days ] [ Designated as safety issue: No ]
Quality of oocytes retrieved [ Time Frame: At the day of oocyte retrieval ] [ Designated as safety issue: No ]
Fertilisation rate of oocytes [ Time Frame: At the day of oocyte retrieval ] [ Designated as safety issue: No ]
Embryo quality [ Time Frame: At the day of embryo transfer ] [ Designated as safety issue: No ]
Number of cryopreserved embryos/blastocysts [ Time Frame: At the day of embryo transfer ] [ Designated as safety issue: No ]
Total dose of r-hFSH required [ Time Frame: At the day of hCG administration ] [ Designated as safety issue: No ]
Number of days of r-hFSH stimulation [ Time Frame: At the day of hCG administration ] [ Designated as safety issue: No ]
Number of patients with cycle cancellation [ Time Frame: At the end of the study ] [ Designated as safety issue: No ]
Number of non-responders [ Time Frame: At the end of the study ] [ Designated as safety issue: No ]
Local and systemic adverse events [ Time Frame: During the study ] [ Designated as safety issue: Yes ]
Implantation rate [ Time Frame: Two weeks after oocyte retrieval ] [ Designated as safety issue: No ]
Clinical pregnancy rate [ Time Frame: Five to six weeks after oocyte retrieval ] [ Designated as safety issue: No ]
Ongoing pregnancy [ Time Frame: After childbirth with questionnaire ] [ Designated as safety issue: No ]
Live birth rate [ Time Frame: After childbirth with questionnaire ] [ Designated as safety issue: No ]

Enrollment:	410
Study Start Date:	June 2010
Study Completion Date:	March 2013
Primary Completion Date:	December 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Active Comparator: Gonal-f® (Follitropin alfa)	Drug: Follitropin alfa 150IU per day subcutaneously for a maximum of 16 days
Experimental: AFOLIA-150 (Follitropin alfa)	Drug: Follitropin alfa 150IU per day subcutaneously for a maximum of 16 days

Eligibility

Ages Eligible for Study:	20 Years to 38 Years
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

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
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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01121666

Locations

Austria
Kinderwunsch Institut Schenk GmbH
Graz, Austria
Landes-Frauenklinik und Kinderklinik Linz
Linz, Austria
AKH Vienna
Vienna, Austria, 1090
IVF Zentrum Döbling
Vienna, Austria, 11920
Privatspital Goldenes Kreuz
Wien, Austria
Denmark
Fertility Clinic
Copenhagen, Denmark, 2100
Copenhagen Fertility Center
Copenhagen, Denmark, 2400
Dansk Fertilitetsklinik
Frederiksberg, Denmark, 2000
Germany
Universitätsklinikum Bonn
Bonn, Germany, 53105
Universitäts-Frauenklinik
Heidelberg, Germany
Spain
Institut Universitari Dexeus
Barcelona, Spain, 08028
IVI Madrid
Madrid, Spain, 28023
Switzerland
University Hospital of Zurich
Zurich, Switzerland, 8091
United Kingdom
Guy's and St Thomas' NHS Foundation Trust
London, United Kingdom, SE1 9RT
Kings College Hospital
London, United Kingdom
St Barthlomew's Hospital
London, United Kingdom

Sponsors and Collaborators

Finox AG

Investigators

Principal Investigator:

Bruno Imthurn

University of Zurich

More Information

No publications provided

Responsible Party:	Finox AG
ClinicalTrials.gov Identifier:	NCT01121666 History of Changes
Other Study ID Numbers:	FIN3001, 2010-019287-37
Study First Received:	May 10, 2010
Last Updated:	April 9, 2013
Health Authority:	Austria: Agency for Health and Food Safety Germany: Federal Institute for Drugs and Medical Devices Switzerland: Swissmedic Denmark: Danish Medicines Agency Spain: Agencia Española de Medicamentos y Productos Sanitarios United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by Finox AG:

Assisted reproductive treatment
Superovulation
Follitropin alfa
r-hFSH
AFOLIA

Additional relevant MeSH terms:

Infertility
Genital Diseases, Male
Genital Diseases, Female
Follicle Stimulating Hormone

Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 19, 2013