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Tracking Information | |||||
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First Received Date † | June 9, 2006 | ||||
Last Updated Date | May 29, 2007 | ||||
Start Date † | March 2003 | ||||
Current Primary Outcome Measures † |
Total number of oocytes retrieved | ||||
Original Primary Outcome Measures † | Same as current | ||||
Change History | Complete list of historical versions of study NCT00335725 on ClinicalTrials.gov Archive Site | ||||
Current Secondary Outcome Measures † |
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 | ||||
Original Secondary Outcome Measures † | Same as current | ||||
Descriptive Information | |||||
Brief Title † | Efficacy and Tolerability of Human FSH Versus Recombinant FSH (Follitropin Alpha) in ICSI. | ||||
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. | ||||
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 |
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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. |
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Study Phase | Phase III | ||||
Study Type † | Interventional | ||||
Study Design † | Treatment, Randomized, Single Blind, Active Control, Parallel Assignment, Safety/Efficacy Study | ||||
Condition † | Infertility | ||||
Intervention † |
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Study Arms / Comparison Groups | |||||
Publications * |
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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Recruitment Information | |||||
Recruitment Status † | Completed | ||||
Enrollment † | 150 | ||||
Completion Date | |||||
Primary Completion Date | |||||
Eligibility Criteria † | Inclusion Criteria: Women undergoing ovarian stimulation for IntraCytoplasmic Sperm Injection (ICSI) with the following characteristics:
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 |
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Gender | Female | ||||
Ages | 18 Years to 40 Years | ||||
Accepts Healthy Volunteers | No | ||||
Contacts †† | |||||
Location Countries † | France, Hungary | ||||
Expanded Access Status | |||||
Administrative Information | |||||
NCT ID † | NCT00335725 | ||||
Responsible Party | |||||
Secondary IDs †† | |||||
Study Sponsor † | IBSA Institut Biochimique SA | ||||
Collaborators †† | |||||
Investigators † |
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Information Provided By | IBSA Institut Biochimique SA | ||||
Verification Date | May 2007 | ||||
† Required WHO trial registration data element. †† WHO trial registration data element that is required only if it exists. |