Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

A Study of the Efficacy and Safety of Highly Purified Menotrophin Versus Recombinant Follitropin Alfa

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00257556
Recruitment Status : Completed
First Posted : November 23, 2005
Results First Posted : February 26, 2010
Last Update Posted : February 26, 2010
Sponsor:
Information provided by:
Ferring Pharmaceuticals

Tracking Information
First Submitted Date  ICMJE November 22, 2005
First Posted Date  ICMJE November 23, 2005
Results First Submitted Date  ICMJE January 8, 2010
Results First Posted Date  ICMJE February 26, 2010
Last Update Posted Date February 26, 2010
Study Start Date  ICMJE October 2005
Actual Primary Completion Date July 2008   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 12, 2010)
  • 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 ]
Original Primary Outcome Measures  ICMJE Not Provided
Change History Complete list of historical versions of study NCT00257556 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: February 12, 2010)
  • 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 ]
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study of the Efficacy and Safety of Highly Purified Menotrophin Versus Recombinant Follitropin Alfa
Official Title  ICMJE 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
Brief Summary Prospective open label, randomised, parallel group, comparative pilot.
Detailed Description 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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Infertility
Intervention  ICMJE
  • Drug: Menotrophin
    150 IU Menotrophin daily subcutaneous injection for a maximum of 13 days. In the event of hyperstimulation, the dose was reduced to 75 IU daily.
    Other Names:
    • Menopur
    • hMG
    • highly purified menotrophin
  • Drug: Follitropin alfa
    150 IU follitropin alfa daily by subcutaneous injection for a maximum of 13 days. In the event of hyperstimulation, the dose was reduced to 75 IU daily.
    Other Names:
    • rFSH
    • recombinant FSH
Study Arms  ICMJE
  • Experimental: Menotrophin
    Intervention: Drug: Menotrophin
  • Active Comparator: Follitropin alfa
    Intervention: Drug: Follitropin alfa
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 2, 2009)
80
Original Enrollment  ICMJE
 (submitted: November 22, 2005)
72
Actual Study Completion Date  ICMJE April 2009
Actual Primary Completion Date July 2008   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 20 Years to 35 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Germany,   United Kingdom
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00257556
Other Study ID Numbers  ICMJE FE999906 CS004 (PROSPECT)
2004-001307-35 ( Registry Identifier: EudraCT )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Clinical Development Support, Ferring Pharmaceuticals
Study Sponsor  ICMJE Ferring Pharmaceuticals
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Clinical Development Support Ferring Pharmaceuticals
PRS Account Ferring Pharmaceuticals
Verification Date February 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP