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

Primary Purpose

Infertility

Status

Completed

Phase

Phase 3

Locations

Italy

Study Type

Interventional

Intervention

hMG-IBSA

Ovarian stimulation

About this trial

This is an interventional treatment trial for Infertility

Eligibility Criteria

20 Years - 40 Years (Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

Ospedale S. Martino
Ospedale S. Paolo
Ospedale Federico II
Ospedale S. Anna

Outcomes

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,

Full Information

NCT ID

NCT00464607

First Posted

April 20, 2007

Last Updated

April 20, 2007

Sponsor

IBSA Institut Biochimique SA

1. Study Identification

Unique Protocol Identification Number

NCT00464607

Brief Title

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

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 Type

Interventional

2. Study Status

Record Verification Date

April 2007

Overall Recruitment Status

Completed

Study Start Date

December 2001 (undefined)

Primary Completion Date

undefined (undefined)

Study Completion Date

April 2005 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

IBSA Institut Biochimique SA

4. Oversight

Data Monitoring Committee

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Infertility

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

160 (false)

8. Arms, Groups, and Interventions

Intervention Type

Drug

Intervention Name(s)

hMG-IBSA

Intervention Type

Procedure

Intervention Name(s)

Ovarian stimulation

Primary Outcome Measure Information:

Title

Number of oocytes recovered

Secondary Outcome Measure Information:

Title

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

20 Years

Maximum Age & Unit of Time

40 Years

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Nicola Ragni, Prof.

Organizational Affiliation

Ospedale S.Martino - Genova (Italy)

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Luigi Fedele, Prof.

Organizational Affiliation

Ospedale S. Paolo - Milano (Italy)

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Giuseppe De Placido, Prof.

Organizational Affiliation

Ospedale Federico II - Napoli (Italy)

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Marco Massobrio, Prof.

Organizational Affiliation

Ospedale S. Anna - Torino (Italy)

Official's Role

Principal Investigator

Facility Information:

Facility Name

Ospedale S. Martino

City

Genova

ZIP/Postal Code

16132

Country

Italy

Facility Name

Ospedale S. Paolo

City

Milano

ZIP/Postal Code

20142

Country

Italy

Facility Name

Ospedale Federico II

City

Napoli

ZIP/Postal Code

80131

Country

Italy

Facility Name

Ospedale S. Anna

City

Torino

ZIP/Postal Code

10126

Country

Italy

12. IPD Sharing Statement

Learn more about this trial

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

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