Infertility Clinical Trial
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)
Verified date | December 2008 |
Source | IBSA Institut Biochimique SA |
Contact | n/a |
Is FDA regulated | No |
Health authority | Italy: The Italian Medicines Agency |
Study type | Interventional |
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 reference drug hMG (Menopur, Ferring Pharmaceuticals, Inc.).
Status | Completed |
Enrollment | 144 |
Est. completion date | March 2009 |
Est. primary completion date | May 2008 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years to 36 Years |
Eligibility |
Inclusion Criteria: - 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 Criteria: - 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. |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Italy | Università degli Studi di Bologna | Bologna | |
Italy | Università degli Studi di Napoli Federico II | Napoli |
Lead Sponsor | Collaborator |
---|---|
IBSA Institut Biochimique SA |
Italy,
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* Note: There are 14 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | total number of oocytes retrieved 34 - 36 hours after hCG administration. | |||
Secondary | Total dose of hMG (IU); number of days of hMG stimulation and stimulation duration; cancellation rate with reasons; 17ß-estradiol (E2) serum concentration; number of follicles >16 mm. | |||
Secondary | number of mature oocytes and inseminated oocytes; fertilization rate. | |||
Secondary | embryo score; number of transferred embryos; implantation rate, number of transferred embryos; clinical pregnancy rate | |||
Secondary | Tolerability evaluation |
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