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

Sponsor
IBSA Institut Biochimique SA (Industry)
Overall Status
Completed
CT.gov ID
NCT00335725
Collaborator
(none)
151
Enrollment
7
Locations
2
Arms
33.1
Duration (Months)
21.6
Patients Per Site
0.7
Patients Per Site Per Month

Study Details

Study Description

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

Condition or Disease Intervention/Treatment Phase
  • Drug: Follicle Stimulating Hormone
  • Drug: Follicle Stimulating Hormone
 Phase 3

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 Design

Study Type:
Interventional
Actual Enrollment :
151 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single
Primary Purpose:
Treatment
Official Title:
Multicentric Prospective, Randomised, Controlled Clinical Study on Clinical Efficacy and Tolerability of Urinary FSH (Fostimon® , IBSA) Versus r-FSH (Gonal-F®, Serono) in ICSI.
Study Start Date :
Mar 1, 2003
Actual Primary Completion Date :
Dec 1, 2005
Actual Study Completion Date :
Dec 1, 2005

Arms and Interventions

Arm Intervention/Treatment
Experimental: Fostimon

Fostimon is an highly purified FSH preparation.

Drug: Follicle Stimulating Hormone
subcutaneous injection of FSH. Starting dose: 225 IU.
Other Names:
  • highly purified human derived FSH; Fostimon

    		•
    Active Comparator: Gonal-F

    Gonal-F is a recombinant FSH preparation.

    Drug: Follicle Stimulating Hormone
    subcutaneous injection of FSH. Starting dose: 225 IU.
    Other Names:
  • rec FSH; Gonal F

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Total Number of Oocytes Retrieved [10 days after stimulation start]

      Total number of oocytes retrieved

    Secondary Outcome Measures

    1. Clinical Pregnancy Rate [6 weeks after treatment start]

      clinical pregnancy rate defined as the presence of gestation sac and heart beat.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 40 Years
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Private Consulting Bron France
    2 Hôpital Jeanne de Flandre Lille France
    3 Hôpital Edouard Herriot Lyon France
    4 Institut de Médecine de la Reproduction Marseille France
    5 Hôpital Américain Neuilly sur Seine France
    6 Hôpital Tenon Paris France
    7 Semmelweis Medical School Budapest Hungary

    Sponsors and Collaborators

    • IBSA Institut Biochimique SA

    Investigators

    • Principal Investigator: J G Grudzinskas, Prof, The Bridge Centre One St Thomas Street London Bridge London SE1 9RY, UK2.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT00335725
    Other Study ID Numbers:
    • 01GBF/FSH08
    First Posted:
    Jun 12, 2006
    Last Update Posted:
    Mar 27, 2015
    Last Verified:
    Mar 1, 2015
    Keywords provided by , ,
    Ovarian stimulation
    Infertility
    ICSI
    FSH
    Additional relevant MeSH terms:
    Infertility
    Hormones
    Follicle Stimulating Hormone

    Study Results

    Participant Flow

    Recruitment Details
    Pre-assignment Detail
    Arm/Group Title Fostimon Gonal-f
    Arm/Group Description Highly purified FSH Recombinant FSH
    Period Title: Overall Study
    STARTED 75 76
    COMPLETED 71 71
    NOT COMPLETED 4 5

    Baseline Characteristics

    Arm/Group Title Fostimon Gonal-f Total
    Arm/Group Description Total of all reporting groups
    Overall Participants 75 76 151
    Age (years) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [years]
    29.9
    (4.0)
    30.0
    (3.6)
    30.0
    (3.8)
    Sex: Female, Male (Count of Participants)
    Female
    75
    100%
    76
    100%
    151
    100%
    Male
    0
    0%
    0
    0%
    0
    0%
    basal FSH (IU/L) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [IU/L]
    5.9
    (2.5)
    6.0
    (1.9)
    6.0
    (2.2)

    Outcome Measures

    1. Primary Outcome
    Title Total Number of Oocytes Retrieved
    Description Total number of oocytes retrieved
    Time Frame 10 days after stimulation start

    Outcome Measure Data

    Analysis Population Description
    patients who started the stimulation with FSH
    Arm/Group Title Fostimon Gonal-f
    Arm/Group Description
    Measure Participants 73 72
    Mean (Standard Deviation) [oocytes]
    10.9
    (4.9)
    12.0
    (5.6)
    2. Secondary Outcome
    Title Clinical Pregnancy Rate
    Description clinical pregnancy rate defined as the presence of gestation sac and heart beat.
    Time Frame 6 weeks after treatment start

    Outcome Measure Data

    Analysis Population Description
    patients who started the FSH treatment
    Arm/Group Title Fostimon Gonal-F
    Arm/Group Description
    Measure Participants 73 72
    Number [percentage of treated patients]
    30.1
    29.2

    Adverse Events

    Time Frame
    Adverse Event Reporting Description
    Arm/Group Title Fostimon Gonal-F
    Arm/Group Description
    All Cause Mortality
    Fostimon Gonal-F
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total / (NaN) / (NaN)
    Serious Adverse Events
    Fostimon Gonal-F
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 2/73 (2.7%) 5/72 (6.9%)
    Pregnancy, puerperium and perinatal conditions
    OHSS 1/73 (1.4%) 1 4/72 (5.6%) 4
    Ectopic pregnancy 1/73 (1.4%) 1 0/72 (0%) 0
    Spontaneous abortion 0/73 (0%) 0 1/72 (1.4%) 1
    Other (Not Including Serious) Adverse Events
    Fostimon Gonal-F
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 3/73 (4.1%) 3/72 (4.2%)
    General disorders
    tiredness 0/73 (0%) 0 1/72 (1.4%) 1
    Pregnancy, puerperium and perinatal conditions
    spontaneous abortion 1/73 (1.4%) 1 1/72 (1.4%) 1
    Ovarian cyst 2/73 (2.7%) 2 1/72 (1.4%) 1

    Limitations/Caveats

    [Not Specified]

    More Information

    Certain Agreements

    Principal Investigators are NOT employed by the organization sponsoring the study.

    There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

    Results Point of Contact

    Name/Title IBSA Clinical Research Manager
    Organization IBSA instutut Biochimique SA
    Phone +41 58 360 1000
    Email sd@ibsa.ch
    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT00335725
    Other Study ID Numbers:
    • 01GBF/FSH08
    First Posted:
    Jun 12, 2006
    Last Update Posted:
    Mar 27, 2015
    Last Verified:
    Mar 1, 2015