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

NCT00464607 | Completed Phase 3

• 1 other identifier: 00IF/HMG06
• Study Type: interventional
• Target: 160
• Locations: 1 country
• Sites: 4

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).

Conditions

Infertility

Outcome Measures

Primary Outcomes (1)

• Number of oocytes recovered

Secondary Outcomes (2)

• 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,

Interventions

hMG-IBSA DRUG

Ovarian stimulation PROCEDURE

Eligibility Criteria

• Age: 20 Years - 40 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• IBSA Institut Biochimique SA: lead

Study Sites (4)

Ospedale S. Martino

Genova, Genova, 16132, Italy

Location

Ospedale S. Paolo

Milan, Milano, 20142, Italy

Location

Ospedale Federico II

Napoli, Napoli, 80131, Italy

Location

Ospedale S. Anna

Torino, Torino, 10126, Italy

Location

MeSH Terms

Conditions

Infertility

Interventions

hMG-IBSA; Ovulation Induction

Condition Hierarchy (Ancestors)

Genital Diseases; Urogenital Diseases

Intervention Hierarchy (Ancestors)

Reproductive Techniques, Assisted; Reproductive Techniques; Therapeutics; Investigative Techniques

Study Officials

• 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)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: April 20, 2007
• First Posted: April 23, 2007
• Study Start: December 1, 2001
• Study Completion: April 1, 2005
• Last Updated: April 23, 2007

Record last verified: 2007-04

Locations

IT (4)