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

Phase 3

Completed

• Conditions: Infertility

• Registration Number: NCT00464607
• Lead Sponsor: 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).

Detailed Description

Not available

Study Timeline

• Study Start: 2001-12
• Study Completion: 2005-04
• Status Verified: 2007-04
• Study First Submitted: 2007-04-20
• Study First Submitted QC: 2007-04-20
• Last Update Submitted: 2007-04-20
• Study First Posted: 2007-04-23
• Last Update Posted: 2007-04-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 160

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.

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Number of oocytes recovered

Secondary Outcome Measures

Name	Time	Method
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,

Trial Locations

Locations (4)

Ospedale S. Martino; 🇮🇹 Genova, Italy

Ospedale Federico II; 🇮🇹 Napoli, Italy

Ospedale S. Anna; 🇮🇹 Torino, Italy

Ospedale S. Paolo; 🇮🇹 Milano, Italy