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Efficacy and Tolerability of Human FSH Versus Recombinant FSH (Follitropin Alpha) in ICSI.

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ClinicalTrials.gov Identifier: NCT00335725
Recruitment Status : Completed
First Posted : June 12, 2006
Results First Posted : March 27, 2015
Last Update Posted : March 27, 2015
Sponsor:
Information provided by:
IBSA Institut Biochimique SA

Tracking Information
First Submitted Date  ICMJE June 9, 2006
First Posted Date  ICMJE June 12, 2006
Results First Submitted Date  ICMJE February 12, 2015
Results First Posted Date  ICMJE March 27, 2015
Last Update Posted Date March 27, 2015
Study Start Date  ICMJE March 2003
Actual Primary Completion Date December 2005   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 23, 2015)
Total Number of Oocytes Retrieved [ Time Frame: 10 days after stimulation start ]
Total number of oocytes retrieved
Original Primary Outcome Measures  ICMJE
 (submitted: June 9, 2006)
Total Number of Oocytes Retrieved
Change History Complete list of historical versions of study NCT00335725 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: March 23, 2015)
Clinical Pregnancy Rate [ Time Frame: 6 weeks after treatment start ]
clinical pregnancy rate defined as the presence of gestation sac and heart beat.
Original Secondary Outcome Measures  ICMJE
 (submitted: June 9, 2006)
total dose of FSH (IU);number of days of FSH stimulation and duration of stimulation;cancellation rate; oestradiol serum concentration on the day of hCG injection; number of follicles >14 mm on the day of hCG injection.Fertilization rate (Day 1; cleavage
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Efficacy and Tolerability of Human FSH Versus Recombinant FSH (Follitropin Alpha) in ICSI.
Official Title  ICMJE Multicentric Prospective, Randomised, Controlled Clinical Study on Clinical Efficacy and Tolerability of Urinary FSH (Fostimon® , IBSA) Versus r-FSH (Gonal-F®, Serono) in ICSI.
Brief Summary Purpose of the study is the comparative evaluation of the clinical efficacy and of the general tolerability of two different subcutaneous FSH preparations (Fostimon® IBSA Vs Gonal-F® Serono) when administered in patients undergoing ICSI
Detailed Description

This is a multicentric, prospective, randomised, investigator blind, controlled clinical trial (phase III) of two parallel groups, one receiving the test drug FSH (Fostimon® , IBSA) and the other the reference drug FSH (Gonal-F®, Serono). The groups will be paired on the major prognostic criteria.

In effect, a double blind trial is not really feasible since the drugs presentations are very different. However, in IVF, drugs are usually dispensed and/or injected by a nurse and therefor the Investigator can be blind. Moreover, the used preparations will contain the same amount of gonadotrophin units (75 IU), will be repackaged in anonymous boxes and the following sentence will be written in the Patient Information Sheet: "You are required not to inform the Investigator about the product's name".

The randomisation is necessary to get groups as comparable as possible for all the other aspects. The multicentric design has the double interest of facilitating the patients' recruitment and of decreasing the biases related to attitudes in a specific centre.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single
Primary Purpose: Treatment
Condition  ICMJE Infertility
Intervention  ICMJE
  • Drug: Follicle Stimulating Hormone
    subcutaneous injection of FSH. Starting dose: 225 IU.
    Other Name: highly purified human derived FSH; Fostimon
  • Drug: Follicle Stimulating Hormone
    subcutaneous injection of FSH. Starting dose: 225 IU.
    Other Name: rec FSH; Gonal F
Study Arms  ICMJE
  • Experimental: Fostimon
    Fostimon is an highly purified FSH preparation.
    Intervention: Drug: Follicle Stimulating Hormone
  • Active Comparator: Gonal-F
    Gonal-F is a recombinant FSH preparation.
    Intervention: Drug: Follicle Stimulating Hormone
Publications *

*   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 23, 2015)
151
Original Enrollment  ICMJE
 (submitted: June 9, 2006)
150
Actual Study Completion Date  ICMJE December 2005
Actual Primary Completion Date December 2005   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

Women undergoing ovarian stimulation for IntraCytoplasmic Sperm Injection (ICSI) with the following characteristics:

>/= 18 and < 40 years old BMI between 19 and 30 kg/m2 less than 3 previous completed cycles basal FSH level less than 10 IU/l within the 6 months prior to the study

Exclusion Criteria:

age < 18 and >/= 40 years primary ovarian failure or women known as poor responders, i.e. requiring more than 225 IU of FSH as starting dose in previous treatment cycles or having less than 3 oocytes retrieved or with an oestradiol serum concentration < 900 pmol/l (250 pg/ml) ovarian cysts > 20 mm oocyte donation thawed embryos replacement patients affected by pathologies associated with any contraindication of being pregnant ascertained or presumptive hypersensitivity to the active principle and/or their ingredients abnormal bleeding of undetermined origin uncontrolled thyroid or adrenal dysfunction neoplasias severe impairment of the renal and/or hepatic functions women deprived of their freedom by administrative or legal decision

Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years to 40 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE France,   Hungary
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00335725
Other Study ID Numbers  ICMJE 01GBF/FSH08
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Not Provided
Study Sponsor  ICMJE IBSA Institut Biochimique SA
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: J G Grudzinskas, Prof The Bridge Centre One St Thomas Street London Bridge London SE1 9RY, UK2.
PRS Account IBSA Institut Biochimique SA
Verification Date March 2015

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