Clinical Study of Clinical Efficacy and Tolerability of hMG-IBSA s.c.in Women Undergoing COH in an ART Programme (IVF).
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|ClinicalTrials.gov Identifier: NCT00335894|
Recruitment Status : Completed
First Posted : June 12, 2006
Last Update Posted : March 10, 2010
|Condition or disease||Intervention/treatment||Phase|
|Infertility||Drug: hMG-IBSA||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||144 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||A Prospective, Randomized, Investigator-blind, Controlled, Clinical Study of Phase III on the Efficacy and Tolerability of hMG-IBSA (IBSA) vs Menopur (Ferring) Administered s.c. in Women Undergoing COH in an ART Programme (IVF)|
|Study Start Date :||May 2005|
|Actual Primary Completion Date :||May 2008|
|Study Completion Date :||March 2009|
- total number of oocytes retrieved 34 - 36 hours after hCG administration.
- Total dose of hMG (IU); number of days of hMG stimulation and stimulation duration; cancellation rate with reasons; 17β-estradiol (E2) serum concentration; number of follicles >16 mm.
- number of mature oocytes and inseminated oocytes; fertilization rate.
- embryo score; number of transferred embryos; implantation rate, number of transferred embryos; clinical pregnancy rate
- Tolerability evaluation
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00335894
|Università degli Studi di Bologna|
|Bologna, Italy, 40138|
|Università degli Studi di Napoli Federico II|
|Napoli, Italy, 80131|
|Study Director:||Giuseppe De Placido, Prof||Federico II University|