A Prospective, Randomized, Investigator-blind, Controlled, Clinical Study of Phase III on the Efficacy and Tolerability of hMG-IBSA (IBSA) vs Menopur (Ferring) Administered s.c. in Women Undergoing COH in an ART Programme (IVF)

IBSA Institut Biochimique SA2 sites in 1 country144 target enrollmentMay 2005

ConditionsInfertility

DrugshMG-IBSA

Overview

Phase: Phase 3
Intervention: Not specified
Conditions: Infertility
Sponsor: IBSA Institut Biochimique SA
Enrollment: 144
Locations: 2
Primary Endpoint: total number of oocytes retrieved 34 - 36 hours after hCG administration.
Status: Completed
Last Updated: 16 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

Multicenter, prospective, randomized, investigator blind, controlled clinical trial. Two parallel groups, one receiving the test drug hMG (hMG-IBSA, IBSA Institut Biochimique sa) and the other the reference drug hMG (Menopur, Ferring Pharmaceuticals, Inc.).

Detailed Description

The purpose of the study is to evaluate the clinical efficacy and general tolerability of two different subcutaneous hMG preparations (hMG-IBSA, IBSA vs Menopur, Ferring Pharmaceuticals, Inc.) when administered to patients undergoing controlled ovarian stimulation for IVF.

Registry

clinicaltrials.gov

Start Date

May 2005

End Date

March 2009

Last Updated

16 years ago

Study Type

Interventional

Study Design

Parallel

Sex

Female

Investigators

Sponsor

IBSA Institut Biochimique SA

Eligibility Criteria

Inclusion Criteria

•Women undergoing ovarian stimulation for IVF with or without ICSI (intracytoplasmic sperm injection) and with the following characteristics:
•Voluntary given informed consent to study participation in writing encompassing consent to data recording and verification procedures;
•\> 18/= and \< 37 years old;
•BMI between 18 and 28 kg/m2;
•Less than 3 previous completed IVF cycles;
•Basal FSH level less than 10 IU/L once within 6 months prior to the study;
•Within 12 month of the beginning of the study, uterine cavity consistent with expected normal function as assessed through a hysterosalpingogram, or sonohysterogram, or hysteroscopic examination or TVUS;
•Normal or clinically insignificant haematology and blood chemistry values.

Exclusion Criteria

•Primary ovarian failure or women known as poor responders;
•Signs of PCO, according to the Rotterdam Criteria;
•At least one ovary inaccessible for oocyte retrieval;
•One or more ovarian cysts \> 10 mm;
•Hydrosalpinx that have not been surgically removed or ligated;
•Stage III or IV endometriosis;
•Patients affected by pathologies associated with any contraindication of being pregnant;
•Hypersensitivity to the study medication;
•Abnormal bleeding of undetermined origin;
•Uncontrolled thyroid or adrenal dysfunction;

Outcomes

Primary Outcomes

total number of oocytes retrieved 34 - 36 hours after hCG administration.

Secondary Outcomes

Total dose of hMG (IU); number of days of hMG stimulation and stimulation duration; cancellation rate with reasons; 17β-estradiol (E2) serum concentration; number of follicles >16 mm.
number of mature oocytes and inseminated oocytes; fertilization rate.
embryo score; number of transferred embryos; implantation rate, number of transferred embryos; clinical pregnancy rate
Tolerability evaluation