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

Infertility Clinical Trial

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00464607
• Other study ID #: 00IF/HMG06
• Status: Completed
• Phase: Phase 3
• First received: April 20, 2007
• Last updated: April 20, 2007
• Start date: December 2001
• Est. completion date: April 2005

Study information

• Verified date: April 2007
• Source: IBSA Institut Biochimique SA
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: The Italian Medicines Agency
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 160
• Est. completion date: April 2005
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 20 Years to 40 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Infertility

Intervention

Drug:
• hMG-IBSA

Procedure:
• Ovarian stimulation

Locations

Country	Name	City	State
Italy	Ospedale S. Martino	Genova
Italy	Ospedale S. Paolo	Milano
Italy	Ospedale Federico II	Napoli
Italy	Ospedale S. Anna	Torino

Sponsors (1)

Lead Sponsor	Collaborator
IBSA Institut Biochimique SA

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of oocytes recovered
Secondary	Efficacy: Day of Oocyte collection, 17ß-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
Secondary	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,