Clinical trial NCT00464607: Prospective, Randomized, Controlled, Clinical Study on Tolerability and Efficacy of hMG-IBSA
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)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Infertility
Lead sponsor: IBSA Institut Biochimique SA
Sponsor class: INDUSTRY
First posted: 2007-04-23
Enrollment: 160
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).


Eligibility 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

Primary outcomes:
measure: Number of oocytes recovered
Secondary outcomes:
measure: 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
measure: 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,
Other outcomes:
Locations:
city: Genova
country: Italy
facility: Ospedale S. Martino
city: Milano
country: Italy
facility: Ospedale S. Paolo
city: Napoli
country: Italy
facility: Ospedale Federico II
city: Torino
country: Italy
facility: Ospedale S. Anna
Study officials:
affiliation: Ospedale S.Martino - Genova (Italy)
name: Nicola Ragni, Prof.
role: PRINCIPAL_INVESTIGATOR
affiliation: Ospedale S. Paolo - Milano (Italy)
name: Luigi Fedele, Prof.
role: PRINCIPAL_INVESTIGATOR
affiliation: Ospedale Federico II - Napoli (Italy)
name: Giuseppe De Placido, Prof.
role: PRINCIPAL_INVESTIGATOR
affiliation: Ospedale S. Anna - Torino (Italy)
name: Marco Massobrio, Prof.
role: PRINCIPAL_INVESTIGATOR
References: