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
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|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
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|Ages Eligible for Study:||18 Years to 36 Years (Adult)|
|Sexes Eligible for Study:||Female|
|Accepts Healthy Volunteers:||No|
- Women undergoing ovarian stimulation for IVF with or without ICSI (intracytoplasmic sperm injection) and with the following characteristics:
- Voluntary given informed consent to study participation in writing encompassing consent to data recording and verification procedures;
- > 18/= and < 37 years old;
- BMI between 18 and 28 kg/m2;
- Less than 3 previous completed IVF cycles;
- Basal FSH level less than 10 IU/L once within 6 months prior to the study;
- Within 12 month of the beginning of the study, uterine cavity consistent with expected normal function as assessed through a hysterosalpingogram, or sonohysterogram, or hysteroscopic examination or TVUS;
- Normal or clinically insignificant haematology and blood chemistry values.
- Primary ovarian failure or women known as poor responders;
- Signs of PCO, according to the Rotterdam Criteria;
- At least one ovary inaccessible for oocyte retrieval;
- One or more ovarian cysts > 10 mm;
- Hydrosalpinx that have not been surgically removed or ligated;
- Stage III or IV endometriosis;
- Patients affected by pathologies associated with any contraindication of being pregnant;
- Hypersensitivity to the study medication;
- Abnormal bleeding of undetermined origin;
- Uncontrolled thyroid or adrenal dysfunction;
- PAP smear III within the last 2 years;
- Severe impairment of the renal and/or hepatic functions;
- Participation in a concurrent clinical trial or in another trial within the past four weeks;
- Use of concomitant medication that might interfere with study evaluations.
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|
|Other Study ID Numbers:||
|First Posted:||June 12, 2006 Key Record Dates|
|Last Update Posted:||March 10, 2010|
|Last Verified:||December 2008|