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

April 20, 2007 updated by: IBSA Institut Biochimique SA

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)

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment

160

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Genova, Italy, 16132
        • Ospedale S. Martino
      • Milano, Italy, 20142
        • Ospedale S. Paolo
      • Napoli, Italy, 80131
        • Ospedale Federico II
      • Torino, Italy, 10126
        • Ospedale S. Anna

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 40 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Number of oocytes recovered

Secondary Outcome Measures

Outcome Measure
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,

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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)

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2001

Study Completion (Actual)

April 1, 2005

Study Registration Dates

First Submitted

April 20, 2007

First Submitted That Met QC Criteria

April 20, 2007

First Posted (Estimate)

April 23, 2007

Study Record Updates

Last Update Posted (Estimate)

April 23, 2007

Last Update Submitted That Met QC Criteria

April 20, 2007

Last Verified

April 1, 2007

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 00IF/HMG06

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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