Trial document





This study has been imported from ClinicalTrials.gov without additional data checks.
drksid header

  DRKS00004132

Trial Description

start of 1:1-Block title

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

end of 1:1-Block title
start of 1:1-Block acronym

Trial Acronym

[---]*

end of 1:1-Block acronym
start of 1:1-Block url

URL of the Trial

[---]*

end of 1:1-Block url
start of 1:1-Block public summary

Brief Summary in Lay Language

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

end of 1:1-Block public summary
start of 1:1-Block scientific synopsis

Brief Summary in Scientific Language

[---]*

end of 1:1-Block scientific synopsis
start of 1:1-Block organizational data

Organizational Data

  •   DRKS00004132
  •   2012/10/16
  •   2010/05/10
  •   no
  •   [---]*
  •   [---]*
end of 1:1-Block organizational data
start of 1:n-Block secondary IDs

Secondary IDs

  •   2010-019287-37 
  •   NCT01121666  (ClinicalTrials.gov)
  •   FIN3001  (Finox AG)
  •   2010-019287-37 
end of 1:n-Block secondary IDs
start of 1:N-Block indications

Health Condition or Problem studied

  •   Infertility
  •   N97 -  Female infertility
end of 1:N-Block indications
start of 1:N-Block interventions

Interventions/Observational Groups

  •   Drug: Follitropin alfa
end of 1:N-Block interventions
start of 1:1-Block design

Characteristics

  •   Interventional
  •   [---]*
  •   Randomized controlled trial
  •   Blinded
  •   assessor
  •   Active control (effective treament of control group)
  •   Treatment
  •   Parallel
  •   III
  •   [---]*
end of 1:1-Block design
start of 1:1-Block primary endpoint

Primary Outcome

- 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

end of 1:1-Block primary endpoint
start of 1:1-Block secondary endpoint

Secondary Outcome

- 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
- 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
- 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
- Quality of oocytes retrieved; time frame: At the day of oocyte retrieval
- Fertilisation rate of oocytes; time frame: At the day of oocyte retrieval
- Embryo quality; time frame: At the day of embryo transfer
- Number of cryopreserved embryos/blastocysts; time frame: At the day of embryo transfer
- Total dose of r-hFSH required; time frame: At the day of hCG administration
- Number of days of r-hFSH stimulation; time frame: At the day of hCG administration
- Number of patients with cycle cancellation; time frame: At the end of the study
- Number of non-responders; time frame: At the end of the study
- Local and systemic adverse events; time frame: During the study
- Implantation rate; time frame: Two weeks after oocyte retrieval
- Clinical pregnancy rate; time frame: Five to six weeks after oocyte retrieval
- Ongoing pregnancy; time frame: After childbirth with questionnaire
- Live birth rate; time frame: After childbirth with questionnaire

end of 1:1-Block secondary endpoint
start of 1:n-Block recruitment countries

Countries of Recruitment

  •   Austria
  •   Denmark
  •   Germany
  •   Spain
  •   Switzerland
  •   United Kingdom
end of 1:n-Block recruitment countries
start of 1:n-Block recruitment locations

Locations of Recruitment

  •  
  •  
end of 1:n-Block recruitment locations
start of 1:1-Block recruitment

Recruitment

  •   [---]*
  •   2010/06/30
  •   393
  •   Multicenter trial
  •   International
end of 1:1-Block recruitment
start of 1:1-Block inclusion criteria

Inclusion Criteria

  •   Female
  •   20   Years
  •   38   Years
end of 1:1-Block inclusion criteria
start of 1:1-Block inclusion criteria add

Additional 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

end of 1:1-Block inclusion criteria add
start of 1:1-Block exclusion criteria

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

end of 1:1-Block exclusion criteria
start of 1:n-Block addresses

Addresses

  • start of 1:1-Block address primary-sponsor
    • Finox AG
    end of 1:1-Block address primary-sponsor
    start of 1:1-Block address contact primary-sponsor
    •   [---]*
    •   [---]*
    •   [---]*
    •   [---]*
    end of 1:1-Block address contact primary-sponsor
  • start of 1:1-Block address scientific-contact
    • University of Zurich
    • Bruno Imthurn 
    end of 1:1-Block address scientific-contact
    start of 1:1-Block address contact scientific-contact
    •   [---]*
    •   [---]*
    •   [---]*
    •   [---]*
    end of 1:1-Block address contact scientific-contact
  • start of 1:1-Block address public-contact
    • University of Zurich
    • Bruno Imthurn 
    end of 1:1-Block address public-contact
    start of 1:1-Block address contact public-contact
    •   [---]*
    •   [---]*
    •   [---]*
    •   [---]*
    end of 1:1-Block address contact public-contact
end of 1:n-Block addresses
start of 1:n-Block material support

Sources of Monetary or Material Support

  • start of 1:1-Block address materialSupport
    • Bitte wenden Sie sich an den Sponsor / Please refer to primary sponsor
    end of 1:1-Block address materialSupport
    start of 1:1-Block address contact materialSupport
    •   [---]*
    •   [---]*
    •   [---]*
    •   [---]*
    end of 1:1-Block address contact materialSupport
end of 1:n-Block material support
start of 1:1-Block state

Status

  •   Recruiting complete, follow-up complete
  •   2013/03/01
end of 1:1-Block state
start of 1:n-Block publications

Trial Publications, Results and other Documents

  • [---]*
end of 1:n-Block publications
start of 1:n-Block dynamic attributes

Additional Trial Attributes

  • Urological disease 
  • If other, please specify 
  • Study recommendations 
  • If other, please specify 
  • German director of clinical investigation 
    start of 1:1-Block address
    • [---]*
    end of 1:1-Block address
    start of 1:1-Block address contact
    •   [---]*
    •   [---]*
    •   [---]*
    •   [---]*
    end of 1:1-Block address contact
  • Further contact 
    start of 1:1-Block address
    • [---]*
    end of 1:1-Block address
    start of 1:1-Block address contact
    •   [---]*
    •   [---]*
    •   [---]*
    •   [---]*
    end of 1:1-Block address contact
  • Function of contact 
  • Non-interventional study 
  • Stage 
  • If other, please specify 
  • Onset of therapy 
  • If other, please specify 
end of 1:n-Block dynamic attributes
The parameters in ClinicalTrials.gov and DRKS are not identical. Therefore the data import from ClinicalTrials.gov required adjustments. For full details please see the DRKS FAQs .
  •   5
  •   2016/01/14
* This entry means the parameter is not applicable or has not been set.