Trial | NCT00464607  Report issue

Title

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

  • Phase

    Phase 3

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    160
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).
Study Started
Dec 31
2001
Study Completion
Apr 30
2005
Last Update
Apr 23
2007
Estimate

Drug hMG-IBSA

Procedure Ovarian stimulation

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
No Results Posted