Status:
COMPLETED
Clinical Study of Clinical Efficacy and Tolerability of hMG-IBSA s.c.in Women Undergoing COH in an ART Programme (IVF).
Lead Sponsor:
IBSA Institut Biochimique SA
Conditions:
Infertility
Eligibility:
FEMALE
18-36 years
Phase:
PHASE3
Brief Summary
Multicenter, prospective, randomized, investigator blind, controlled clinical trial. Two parallel groups, one receiving the test drug hMG (hMG-IBSA, IBSA Institut Biochimique sa) and the other the ref...
Detailed Description
The purpose of the study is to evaluate the clinical efficacy and general tolerability of two different subcutaneous hMG preparations (hMG-IBSA, IBSA vs Menopur, Ferring Pharmaceuticals, Inc.) when ad...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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;
- Neoplasias;
- PAP smear III within the last 2 years;
- Severe impairment of the renal and/or hepatic functions;
- Lactation;
- Hyperprolactinaemia;
- 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.
Key Trial Info
Start Date :
May 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 1 2009
Estimated Enrollment :
144 Patients enrolled
Trial Details
Trial ID
NCT00335894
Start Date
May 1 2005
End Date
March 1 2009
Last Update
March 10 2010
Active Locations (2)
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1
Università degli Studi di Bologna
Bologna, Bologna, Italy, 40138
2
Università degli Studi di Napoli Federico II
Napoli, Napoli, Italy, 80131