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)

IBSA Institut Biochimique SA4 sites in 1 country160 target enrollmentDecember 2001

ConditionsInfertility

DrugshMG-IBSA

Overview

Phase: Phase 3
Intervention: Not specified
Conditions: Infertility
Sponsor: IBSA Institut Biochimique SA
Enrollment: 160
Locations: 4
Primary Endpoint: Number of oocytes recovered
Status: Completed
Last Updated: 19 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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).

Registry

clinicaltrials.gov

Start Date

December 2001

End Date

April 2005

Last Updated

19 years ago

Study Type

Interventional

Study Design

Parallel

Sex

Female

Investigators

Sponsor

IBSA Institut Biochimique SA

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

Outcomes

Primary Outcomes

Number of oocytes recovered

Secondary Outcomes

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,