Clinical Study of Clinical Efficacy and Tolerability of hMG-IBSA s.c.in Women Undergoing COH in an ART Programme (IVF).

March 9, 2010 updated by: IBSA Institut Biochimique SA

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)

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.).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The purpose of the study is to evaluate the clinical efficacy and general tolerability of two different subcutaneous hMG preparations (hMG-IBSA, IBSA vs Menopur, Ferring Pharmaceuticals, Inc.) when administered to patients undergoing controlled ovarian stimulation for IVF.

Study Type

Interventional

Enrollment (Anticipated)

144

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
      • Bologna, Italy, 40138
        • Università degli studi di Bologna
      • Napoli, Italy, 80131
        • Università Degli Studi Di Napoli Federico Ii

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

18 years to 36 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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.

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: Single

What is the study measuring?

Primary Outcome Measures

Outcome Measure
total number of oocytes retrieved 34 - 36 hours after hCG administration.

Secondary Outcome Measures

Outcome Measure
Total dose of hMG (IU); number of days of hMG stimulation and stimulation duration; cancellation rate with reasons; 17β-estradiol (E2) serum concentration; number of follicles >16 mm.
number of mature oocytes and inseminated oocytes; fertilization rate.
embryo score; number of transferred embryos; implantation rate, number of transferred embryos; clinical pregnancy rate
Tolerability evaluation

Collaborators and Investigators

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

Sponsor

IBSA Institut Biochimique SA

Investigators

  • Study Director: Giuseppe De Placido, Prof, Federico II University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

May 1, 2005

Primary Completion (Actual)

May 1, 2008

Study Completion

March 1, 2009

Study Registration Dates

First Submitted

June 9, 2006

First Submitted That Met QC Criteria

June 9, 2006

First Posted (Estimate)

June 12, 2006

Study Record Updates

Last Update Posted (Estimate)

March 10, 2010

Last Update Submitted That Met QC Criteria

March 9, 2010

Last Verified

December 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 04I/HMG10

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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