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

NCT01121666 | Completed Phase 3 Results

• 2 other identifiers: FIN30012010-019287-37
• Study Type: interventional
• Target: 460
• Locations: 6 countries
• Sites: 16

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

Keywords

Assisted reproductive treatment; Superovulation; Follitropin alfa; r-hFSH; AFOLIA

Outcome Measures

Primary Outcomes (2)

• Number of Oocytes Retrieved (Per Protocol Population)

  As soon as ovulation criteria were reached, HCG was given to trigger ovulation and 34-36 hours later, oocytes were retrieved. If criteria for ovulation triggering could not be reached by FSH stimulation on day 16, treatment was to be stopped. The equivalence in the number of retrieved oocytes was tested using a pre-determined clinical equivalence margin of +/- 2.9 oocytes

  34-36 hours after hCG administration and after maximum 16 days of r-hFSH treatment

• Number of Oocytes Retrieved (Intention-to-treat Population)

  As soon as ovulation criteria were reached, HCG was given to trigger ovulation and 34-36 hours later, oocytes were retrieved. If criteria for ovulation triggering could not be reached by FSH stimulation on day 16, treatment was to be stopped. The equivalence in the number of retrieved oocytes was tested using a pre-determined clinical equivalence margin of +/- 2.9 oocytes

  34-36 hours after hCG administration and after maximum 16 days of r-hFSH treatment

Secondary Outcomes (21)

• Number and Size of Follicles ≥ 12 mm at Day 8 of Stimulation

  Day 8 of stimulation

• E2 Concentration at Day 8 and at Day of hCG Administration

  Day 8 of stimulation and at the day of hCG administration (after max. 16 days of r-FSH treatment)

• Total Dose of r-hFSH Administered

  Day of hCG administration (after maximum 16 days of r-hFSH treatment)

• Quality of Oocytes Retrieved

  34-36 hours after hCG administration

• Fertilisation Rate of Oocytes

  1 day after ovum pick-up

Study Arms (2)

Gonal-f® (Follitropin alfa)

ACTIVE COMPARATOR

Drug: Follitropin alfa

AFOLIA-150 (Follitropin alfa)

EXPERIMENTAL

Drug: Follitropin alfa

Interventions

Follitropin alfa DRUG

150IU per day subcutaneously for a maximum of 16 days

AFOLIA-150 (Follitropin alfa); Gonal-f® (Follitropin alfa)

Eligibility Criteria

• Age: 20 Years - 38 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Finox AG: lead

Study Sites (16)

Kinderwunsch Institut Schenk GmbH

Graz, Austria

Location

Landes-Frauenklinik und Kinderklinik Linz

Linz, Austria

Location

AKH Vienna

Vienna, 1090, Austria

Location

IVF Zentrum Döbling

Vienna, 11920, Austria

Location

Privatspital Goldenes Kreuz

Vienna, Austria

Location

Fertility Clinic

Copenhagen, 2100, Denmark

Location

Copenhagen Fertility Center

Copenhagen, 2400, Denmark

Location

Dansk Fertilitetsklinik

Frederiksberg, 2000, Denmark

Location

Universitätsklinikum Bonn

Bonn, 53105, Germany

Location

Universitäts-Frauenklinik

Heidelberg, Germany

Location

Institut Universitari Dexeus

Barcelona, 08028, Spain

Location

IVI Madrid

Madrid, 28023, Spain

Location

University Hospital of Zurich

Zurich, 8091, Switzerland

Location

Guy's and St Thomas' NHS Foundation Trust

London, SE1 9RT, United Kingdom

Location

Kings College Hospital

London, United Kingdom

Location

St Barthlomew's Hospital

London, United Kingdom

Location

MeSH Terms

Conditions

Infertility

Interventions

follitropin alfa

Condition Hierarchy (Ancestors)

Genital Diseases; Urogenital Diseases

Results Point of Contact

• Title: Dr. Melanie Ruf
• Organization: Five Office Ltd

clin@five.ch

+41 44 9324132

Study Officials

• Bruno Imthurn

  University of Zurich

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 10, 2010
• First Posted: May 12, 2010
• Study Start: June 1, 2010
• Primary Completion: December 1, 2011
• Study Completion: March 1, 2013
• Last Updated: April 15, 2016
• Results First Posted: April 15, 2016

Record last verified: 2016-03

Locations

ES (2); DE (2); GB (3); AU (5); DK (3); CH (1)