Trial document





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

  DRKS00004075

Trial Description

start of 1:1-Block title

Title

A Prospective, Open Label, Randomised, Parallel Group, Comparative Pilot Study to Study the Efficacy and Safety of Highly Purified Menotrophin Versus Recombinant FSH (Follitropin Alfa) Administered Subcutaneously to Subfertile Female Patients Undergoing IVF Using Antagonist Downregulation

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

Prospective open label, randomised, parallel group, comparative pilot.

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

Brief Summary in Scientific Language

Ongoing pregnancy rate, defined as positive fetal heart action 9 weeks after the first
positive pregnancy test. Number/diameter of follicles, number of oocytes retrieved, number
of pronuclear oocytes (referred to as zygotes or pre-embryos in the UK), quality of
pronuclear stage oocytes, number of embryos transferred, quality of embryos, number of
frozen embryos, endometrial thickness and morphology on day of HCG administration, estradiol
levels at day of HCG administration, implantation rate, number of days stimulated with
gonadotrophins and number of ampoules used, clinical pregnancy rate at 6 weeks after the
first positive pregnancy test, pregnancy outcome.

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

Organizational Data

  •   DRKS00004075
  •   2012/11/09
  •   2005/11/22
  •   no
  •   [---]*
  •   [---]*
end of 1:1-Block organizational data
start of 1:n-Block secondary IDs

Secondary IDs

  •   2004-001307-35 
  •   NCT00257556  (ClinicalTrials.gov)
  •   FE999906 CS004 (PROSPECT)  (Ferring Pharmaceuticals)
  •   2004-001307-35 
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: Menotrophin
  •   Drug: Follitropin alfa
end of 1:N-Block interventions
start of 1:1-Block design

Characteristics

  •   Interventional
  •   [---]*
  •   Randomized controlled trial
  •   Open (masking not used)
  •   [---]*
  •   Active control (effective treament of control group)
  •   Treatment
  •   Parallel
  •   IV
  •   [---]*
end of 1:1-Block design
start of 1:1-Block primary endpoint

Primary Outcome

- Number of Participants With an Ongoing Pregnancy; time frame: Approx week 13; 9 weeks or more after the 1st positive pregnancy test
- Percentage of Participants With an Ongoing Pregnancy; time frame: Approx week 13; 9 weeks or more after the first positive pregnancy test

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

Secondary Outcome

- Participants With Varying Numbers of Follicles That Were Greater Than or Equal to 17 Millimeters; time frame: Day 7 and, if appropriate, every 2 days thereafter (Days 9/11/13)
- Participants With Varying Numbers of Oocytes Retrieved; time frame: Approximately study day 15
- Participants With Varying Numbers of Pronuclear Stage Oocytes; time frame: Approximately study day 15
- Participants With Varying Numbers of Embryos Transferred; time frame: Approximately study day 17
- Participants With Varying Numbers of Embryos Frozen; time frame: Approximately study day 17
- Mean Number of Days Stimulated With Gonadotrophins; time frame: study days 1 - 13
- Pregnancy Outcomes; time frame: Approximately 10 months
- Mean Endometrial Thickness; time frame: Day 7 or 9 or 11 or 13
- Mean Estradiol Level; time frame: Day 7 or 9 or 11 or 13

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

Countries of Recruitment

  •   Germany
  •   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

  •   [---]*
  •   2005/10/31
  •   80
  •   Multicenter trial
  •   International
end of 1:1-Block recruitment
start of 1:1-Block inclusion criteria

Inclusion Criteria

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

Additional Inclusion Criteria

Female patients aged > or = 20 and < or = 35 years with a BMI of >18 and <32 kg/m2 who
have received no more than two previous cycles of in vitro fertilisation (IVF) or other
assisted reproductive technique (ART) and whose partners have normal sperm (according to
WHO 1999 criteria).

Inclusion criteria:

- Signed informed consent;

- Subfertile premenopausal female patients eligible for IVF treatment;

- Aged >=20 and <=35 years;

- Body mass index of >18 and <32 kg/m2

- Normal endocrine assessment within the last 6 months;

- Normal pelvic ultrasound (showing two ovaries, no ovarian abnormalities and normal
uterus) within the last 6 months;

- Receipt of no more than two previous cycles of IVF (or other ART);

- At least 3 consecutive ovulatory menstrual cycles of 24-35 days, and documented
evidence of ovulatory cycles within the previous 12 months;

- No fertility-modifying treatment within the 3 months prior to this treatment cycle;

- Infertility attributable to or in association with either tubal factor, or
unexplained causes;

- Sperm of partner classed as normal according to WHO 1999 criteria within the year
prior to beginning therapy;

- Negative serum beta-HCG pregnancy test prior to beginning therapy;

- Clinically normal baseline haematology, clinical chemistry, and urinalysis parameter
values, negative serum HBsAg and HIV antibody tests;

- Screening endocrine test results (estradiol, LH, FSH, progesterone, prolactin, TSH)
in early follicular phase within the normal limits for the clinical laboratory.

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

Exclusion Criteria

Exclusion criteria

- Presence of any clinically relevant systemic disease(e.g. insulin- dependent diabetes
mellitus);

- A history of or current endocrine disease, including polycystic ovary- like syndrome
and hyperprolactinaemia;

- A history of coagulation disorders;

- Persistent ovarian cysts;

- Contraindications for the use of gonadotrophins or GnRH antagonists;

- A history of hypersensitivity to any of the constituents of the study medication or
related compounds;

- Three or more previous cycles of IVF (or other ART);

- A history of alcohol abuse (more than 30 units per week on a regular basis);

- History of chemo- or radiotherapy;

- Currently breast-feeding, pregnant or with a contraindication to pregnancy;

- Diagnosed poor responders in prior IVF treatment;

- History of severe ovarian hyperstimulation syndrome (OHSS) (4 or 5) in former IVF
treatment;

- Investigational drug within the 30 days prior to treatment;

- Any other condition or history that the investigator considers might increase the
risk to the individual.

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

Addresses

  • start of 1:1-Block address primary-sponsor
    • Ferring Pharmaceuticals
    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
    • Ferring Pharmaceuticals
    • Clinical Development Support 
    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
    • Ferring Pharmaceuticals
    • Clinical Development Support 
    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
  •   2009/04/01
end of 1:1-Block state
start of 1:n-Block publications

Trial Publications, Results and other Documents

  • [---]*
end of 1:n-Block publications
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.