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

IBSA

Status and phase

Completed

Phase 3

Conditions

Infertility

Treatments

Procedure: Ovarian stimulation

Drug: hMG-IBSA

Study type

Interventional

Funder types

Industry

Identifiers

NCT00464607

00IF/HMG06

Details and patient eligibility

About

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).

Sex

Female

Ages

20 to 40 years old

Volunteers

No 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