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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00464607
Recruitment Status : Completed
First Posted : April 23, 2007
Last Update Posted : April 23, 2007
Information provided by:
IBSA Institut Biochimique SA

Brief Summary:
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 or disease Intervention/treatment Phase
Infertility Drug: hMG-IBSA Procedure: Ovarian stimulation Phase 3

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 160 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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)
Study Start Date : December 2001
Study Completion Date : April 2005

Primary Outcome Measures :
  1. Number of oocytes recovered

Secondary Outcome Measures :
  1. 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
  2. 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,

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Ages Eligible for Study:   20 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

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 identifier (NCT number): NCT00464607

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
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) Identifier: NCT00464607     History of Changes
Other Study ID Numbers: 00IF/HMG06
First Posted: April 23, 2007    Key Record Dates
Last Update Posted: April 23, 2007
Last Verified: April 2007

Additional relevant MeSH terms:
Genital Diseases, Male
Genital Diseases, Female