Clinical Study of Clinical Efficacy and Tolerability of hMG-IBSA s.c.in Women Undergoing COH in an ART Programme (IVF). - Tabular View

This Tabular View shows the required WHO registration data elements as marked by ^†

Tracking Information

First Received Date ^†

June 9, 2006

Last Updated Date

December 17, 2008

Start Date ^†

May 2005

Current Primary Outcome Measures ^†

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

Original Primary Outcome Measures ^†

Same as current

Change History

Complete list of historical versions of study NCT00335894 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^†

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

Original Secondary Outcome Measures ^†

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

Descriptive Information

Brief Title ^†

Clinical Study of Clinical Efficacy and Tolerability of hMG-IBSA s.c.in Women Undergoing COH in an ART Programme (IVF).

Official Title ^†

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

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 (Menopure, 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 Menopure, Ferring Pharmaceuticals, Inc.) when administered to patients undergoing controlled ovarian stimulation for IVF.

Study Phase

Phase III

Study Type ^†

Interventional

Study Design ^†

Treatment, Randomized, Single Blind, Active Control, Parallel Assignment, Safety/Efficacy Study

Condition ^†

Infertility

Intervention ^†

Drug: hMG-IBSA

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^†

Completed

Enrollment ^†

144

Completion Date

March 2009

Primary Completion Date

May 2008 (final data collection date for primary outcome measure)

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;
Neoplasias;
PAP smear III within the last 2 years;
Severe impairment of the renal and/or hepatic functions;
Lactation;
Hyperprolactinaemia;
Participation in a concurrent clinical trial or in another trial within the past four weeks;
Use of concomitant medication that might interfere with study evaluations.

Gender

Female

Ages

18 Years to 36 Years

Accepts Healthy Volunteers

Contacts ^††

Location Countries ^†

Italy

Expanded Access Status

Administrative Information

NCT ID ^†

NCT00335894

Responsible Party

Secondary IDs ^††

Study Sponsor ^†

IBSA Institut Biochimique SA

Collaborators ^††

Investigators ^†

Study Director:

Giuseppe De Placido, Prof

Federico II University

Information Provided By

IBSA Institut Biochimique SA

Verification Date

December 2008

^† Required WHO trial registration data element.
^†† WHO trial registration data element that is required only if it exists.