Prospective, Randomized, Controlled, Clinical Study on Tolerability and Efficacy of hMG-IBSA
This study has been completed.
Sponsor:
IBSA Institut Biochimique SA
Information provided by:
IBSA Institut Biochimique SA
ClinicalTrials.gov Identifier:
NCT00464607
First received: April 20, 2007
Last updated: NA
Last verified: April 2007
History: No changes posted
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Purpose
Purpose of the study is the evaluation of the tolerability (both local and systemic) and the clinical efficacy (in terms oocytes recovered) of subcutaneously versus intramuscularly administered Merional® (IBSA, Lugano – CH) in patients undergoing controlled ovarian hyperstimulation (COH) in an ART programme (IVF).
| Condition | Intervention | Phase |
|---|---|---|
|
Infertility |
Drug: hMG-IBSA Procedure: Ovarian stimulation |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Prospective, Randomized, Controlled Clinical Study on the Assessment of Tolerability and of Clinical Efficacy of MERIONAL® (hMG-IBSA) Administered Subcutaneously Versus MERIONALâ Administered Intramuscularly in Women Undergoing Controlled Ovarian Hyperstimulation (COH) in an ART Programme (IVF) |
Resource links provided by NLM:
Further study details as provided by IBSA Institut Biochimique SA:
Primary Outcome Measures:
- Number of oocytes recovered
Secondary Outcome Measures:
- Efficacy: Day of Oocyte collection, 17β-estradiol Cmax, Total dose of gonadotrophin (IU) or n° of vials and n° of vials/day,Number of mature follicles (follicles ³ 16 mm in diameter) on hCG day (or one day earlier), Clinical pregnancy rate
- Tolerability: Number of Adverse Events (AEs) experienced during the study, Occurrence of Ovarian Hypestimulation Syndrome (OHSS), Local tolerability at the injection site, Haematological-biochemical laboratory tests, before and after treatment,
| Estimated Enrollment: | 160 |
| Study Start Date: | December 2001 |
| Study Completion Date: | April 2005 |
Eligibility| Ages Eligible for Study: | 20 Years to 40 Years |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Female patients
- 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:
- ascertained or presumptive hypersensitivity to the active principle and/or their ingredients
- 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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00464607
Locations
| Italy | |
| Ospedale S. Martino | |
| Genova, Italy, 16132 | |
| Ospedale S. Paolo | |
| Milano, Italy, 20142 | |
| Ospedale Federico II | |
| Napoli, Italy, 80131 | |
| Ospedale S. Anna | |
| Torino, Italy, 10126 | |
Sponsors and Collaborators
IBSA Institut Biochimique SA
Investigators
| Principal Investigator: | Nicola Ragni, Prof. | Ospedale S.Martino - Genova (Italy) |
| Principal Investigator: | Luigi Fedele, Prof. | Ospedale S. Paolo - Milano (Italy) |
| Principal Investigator: | Giuseppe De Placido, Prof. | Ospedale Federico II - Napoli (Italy) |
| Principal Investigator: | Marco Massobrio, Prof. | Ospedale S. Anna - Torino (Italy) |
More Information
No publications provided
| ClinicalTrials.gov Identifier: | NCT00464607 History of Changes |
| Other Study ID Numbers: | 00IF/HMG06 |
| Study First Received: | April 20, 2007 |
| Last Updated: | April 20, 2007 |
| Health Authority: | Italy: The Italian Medicines Agency |
Additional relevant MeSH terms:
|
Infertility Genital Diseases, Male Genital Diseases, Female |
ClinicalTrials.gov processed this record on May 23, 2013