Prospective, Randomized, Controlled, Clinical Study on Tolerability and Efficacy of hMG-IBSA
NCT ID: NCT00464607
Last Updated: 2007-04-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
160 participants
INTERVENTIONAL
2001-12-31
2005-04-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Interventions
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hMG-IBSA
Ovarian stimulation
Eligibility Criteria
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Inclusion Criteria
* aged between 20 and 40 years
* undergoing ovarian stimulation for the purposes of oocyte retrieval in an assisted conception programme
* Body Mass Index (BMI) 20-28 kg/m2
* early follicular phase FSH level \< 9 IU/l.
Exclusion Criteria
* primary ovarian failure
* ovarian cysts or enlargement not due to polycystic ovarian syndrome
* oocyte donation
* abnormal bleeding of undetermined origin
* patients who have exhibited poor response or requiring doses of more than 300 IU daily in previous treatment cycles or those who have received similar therapies (previous treatment cycles) in the 30 days prior to the beginning of the present study
* uncontrolled thyroid or adrenal dysfunction
* neoplasia
* severe impairment of the renal and/or hepatic functions
* diabetes and active thrombophlebitis, cardiopathies and epilepsy
* presence of clinically significant systemic disease or any contraindication of being pregnant and/or carrying out a pregnancy to term
* presence of any anatomical abnormality of the reproductive system
* being pregnant or breastfeeding
* menopause
20 Years
40 Years
FEMALE
No
Sponsors
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IBSA Institut Biochimique SA
INDUSTRY
Principal Investigators
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Nicola Ragni, Prof.
Role: PRINCIPAL_INVESTIGATOR
Ospedale S.Martino - Genova (Italy)
Luigi Fedele, Prof.
Role: PRINCIPAL_INVESTIGATOR
Ospedale S. Paolo - Milano (Italy)
Giuseppe De Placido, Prof.
Role: PRINCIPAL_INVESTIGATOR
Ospedale Federico II - Napoli (Italy)
Marco Massobrio, Prof.
Role: PRINCIPAL_INVESTIGATOR
Ospedale S. Anna - Torino (Italy)
Locations
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Ospedale S. Martino
Genova, Genova, Italy
Ospedale S. Paolo
Milan, Milano, Italy
Ospedale Federico II
Napoli, Napoli, Italy
Ospedale S. Anna
Torino, Torino, Italy
Countries
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Other Identifiers
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00IF/HMG06
Identifier Type: -
Identifier Source: org_study_id