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

Infertility Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01121666
• Other study ID #: FIN3001
• Secondary ID: 2010-019287-37
• Status: Completed
• Phase: Phase 3
• First received: May 10, 2010
• Last updated: April 9, 2013
• Start date: June 2010
• Est. completion date: March 2013

Study information

• Verified date: April 2013
• Source: Finox AG
• Contact: n/a
• Is FDA regulated: No
• Health authority: Austria: Agency for Health and Food SafetyGermany: Federal Institute for Drugs and Medical DevicesSwitzerland: SwissmedicDenmark: Danish Medicines AgencySpain: Agencia Española de Medicamentos y Productos SanitariosUnited Kingdom: Medicines and Healthcare Products Regulatory Agency
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 410
• Est. completion date: March 2013
• Est. primary completion date: December 2011
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 20 Years to 38 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Infertility

Intervention

Drug:
• Follitropin alfa
150IU per day subcutaneously for a maximum of 16 days

Locations

Country	Name	City	State
Austria	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	Wien
Denmark	Copenhagen Fertility Center	Copenhagen
Denmark	Fertility Clinic	Copenhagen
Denmark	Dansk Fertilitetsklinik	Frederiksberg
Germany	Universitätsklinikum Bonn	Bonn
Germany	Universitäts-Frauenklinik	Heidelberg
Spain	Institut Universitari Dexeus	Barcelona
Spain	IVI Madrid	Madrid
Switzerland	University Hospital of Zurich	Zurich
United Kingdom	Guy's and St Thomas' NHS Foundation Trust	London
United Kingdom	Kings College Hospital	London
United Kingdom	St Barthlomew's Hospital	London

Sponsors (1)

Lead Sponsor	Collaborator
Finox AG

Countries where clinical trial is conducted

Austria,  Denmark,  Germany,  Spain,  Switzerland,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of oocytes retrieved		At the day of hCG administration but not longer than 16 days after start of treatment with r-hFSH	No
Secondary	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		Day 8 of stimulation and at the day of hCG administration but not longer than 16 days	No
Secondary	E2 concentration at day 8 and at day of hCG administration		Day 8 of stimulation and at the day of hCG administration but not longer than 16 days	No
Secondary	Trough level of FSH after repeated administration of r-hFSH		Day 8 of stimulation and at the day of hCG administration but not longer than 16 days	No
Secondary	Quality of oocytes retrieved		At the day of oocyte retrieval	No
Secondary	Fertilisation rate of oocytes		At the day of oocyte retrieval	No
Secondary	Embryo quality		At the day of embryo transfer	No
Secondary	Number of cryopreserved embryos/blastocysts		At the day of embryo transfer	No
Secondary	Total dose of r-hFSH required		At the day of hCG administration	No
Secondary	Number of days of r-hFSH stimulation		At the day of hCG administration	No
Secondary	Number of patients with cycle cancellation		At the end of the study	No
Secondary	Number of non-responders		At the end of the study	No
Secondary	Local and systemic adverse events		During the study	Yes
Secondary	Implantation rate		Two weeks after oocyte retrieval	No
Secondary	Clinical pregnancy rate		Five to six weeks after oocyte retrieval	No
Secondary	Ongoing pregnancy		After childbirth with questionnaire	No
Secondary	Live birth rate		After childbirth with questionnaire	No