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

Primary Purpose

Infertility

Status
Completed
Phase
Phase 3
Locations
Italy
Study Type
Interventional
Intervention
hMG-IBSA
Sponsored by
IBSA Institut Biochimique SA
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Infertility focused on measuring Infertility, IVF, ART, hMG

Eligibility Criteria

18 Years - 36 Years (Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

  • Università degli Studi di Bologna
  • Università degli Studi di Napoli Federico II

Outcomes

Primary Outcome Measures

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

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

Full Information

First Posted
June 9, 2006
Last Updated
March 9, 2010
Sponsor
IBSA Institut Biochimique SA
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1. Study Identification

Unique Protocol Identification Number
NCT00335894
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 Menopur (Ferring) Administered s.c. in Women Undergoing COH in an ART Programme (IVF)
Study Type
Interventional

2. Study Status

Record Verification Date
December 2008
Overall Recruitment Status
Completed
Study Start Date
May 2005 (undefined)
Primary Completion Date
May 2008 (Actual)
Study Completion Date
March 2009 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
IBSA Institut Biochimique SA

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infertility
Keywords
Infertility, IVF, ART, hMG

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Single
Allocation
Randomized
Enrollment
144 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
hMG-IBSA
Primary Outcome Measure Information:
Title
total number of oocytes retrieved 34 - 36 hours after hCG administration.
Secondary Outcome Measure Information:
Title
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.
Title
number of mature oocytes and inseminated oocytes; fertilization rate.
Title
embryo score; number of transferred embryos; implantation rate, number of transferred embryos; clinical pregnancy rate
Title
Tolerability evaluation

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
36 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Giuseppe De Placido, Prof
Organizational Affiliation
Federico II University
Official's Role
Study Director
Facility Information:
Facility Name
Università degli Studi di Bologna
City
Bologna
ZIP/Postal Code
40138
Country
Italy
Facility Name
Università degli Studi di Napoli Federico II
City
Napoli
ZIP/Postal Code
80131
Country
Italy

12. IPD Sharing Statement

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

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