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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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ClinicalTrials.gov Identifier: NCT00335894
Recruitment Status : Completed
First Posted : June 12, 2006
Last Update Posted : March 10, 2010
Sponsor:
Information provided by:
IBSA Institut Biochimique SA

Tracking Information
First Submitted Date  ICMJE June 9, 2006
First Posted Date  ICMJE June 12, 2006
Last Update Posted Date March 10, 2010
Study Start Date  ICMJE May 2005
Actual Primary Completion Date May 2008   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 9, 2006)
total number of oocytes retrieved 34 - 36 hours after hCG administration.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT00335894 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: June 9, 2006)
  • 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  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Clinical Study of Clinical Efficacy and Tolerability of hMG-IBSA s.c.in Women Undergoing COH in an ART Programme (IVF).
Official Title  ICMJE 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)
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single
Primary Purpose: Treatment
Condition  ICMJE Infertility
Intervention  ICMJE Drug: hMG-IBSA
Study Arms  ICMJE Not Provided
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Estimated Enrollment  ICMJE
 (submitted: June 9, 2006)
144
Original Enrollment  ICMJE Same as current
Study Completion Date  ICMJE March 2009
Actual Primary Completion Date May 2008   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years to 36 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Italy
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00335894
Other Study ID Numbers  ICMJE 04I/HMG10
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Not Provided
Study Sponsor  ICMJE IBSA Institut Biochimique SA
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Giuseppe De Placido, Prof Federico II University
PRS Account IBSA Institut Biochimique SA
Verification Date December 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP