Prospective, Randomized, Controlled, Clinical Study on Tolerability and Efficacy of hMG-IBSA

This study has been completed.
Sponsor:
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
  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 September 16, 2014