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Clinical Tolerance and Equivalence of hCG-IBSA vs Recombinant Human Chorionic Gonadotrophin in Women Undergoing In Vitro Fertilisation

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ClinicalTrials.gov Identifier: NCT00335569
Recruitment Status : Completed
First Posted : June 12, 2006
Last Update Posted : June 1, 2011
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 June 1, 2011
Study Start Date  ICMJE August 2005
Primary Completion Date Not Provided
Current Primary Outcome Measures  ICMJE
 (submitted: May 29, 2007)
Total number of oocytes retrieved per patient who received hCG
Original Primary Outcome Measures  ICMJE
 (submitted: June 9, 2006)
Total number of oocytes retrieved per patient who received hCG.
Change History Complete list of historical versions of study NCT00335569 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: May 31, 2011)
  • Number of patients who received hCG with at least one oocyte retrieved, 2PN fertilized oocytes,
  • 2PN or cleaved embryos, implantation rate per embryo transferred; Serum P and hCG concentration on the days of oocyte retrieval, on day of embryo transfer and on day 5-8 post-hCG;
  • Implantation rate;Pregnancy rate.
  • Adverse Events [ Time Frame: from day 1 to 35 +/- 7 days after oocytes retrieval ]
    Adverse events were monitored and collected during all the study period
  • Incidence of moderate or severe OHSS [ Time Frame: From the day of hCG injection until 35 +/- 7 days after oocyte retrieval ]
    The incidence moderate or severe of OHSS will be assessed in both treatment groups
Original Secondary Outcome Measures  ICMJE
 (submitted: June 9, 2006)
  • Number of patients who received hCG with at least one oocyte retrieved, 2PN fertilized oocytes,
  • 2PN or cleaved embryos, implantation rate per embryo transferred; Serum P and hCG concentration on the days of oocyte retrieval, on day of embryo transfer and on day 5-8 post-hCG;
  • Implantation rate;Pregnancy rate.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Clinical Tolerance and Equivalence of hCG-IBSA vs Recombinant Human Chorionic Gonadotrophin in Women Undergoing In Vitro Fertilisation
Official Title  ICMJE A Prospective, Randomized, Controlled Clinical Study on the Assessment of Tolerance and Clinical Equivalence of hCG- IBSA (IBSA) Versus Ovitrelle (Serono), Both Administered Sub-cutaneously in Women Undergoing in Vitro Fertilization (IVF).
Brief Summary The purpose of the study is to evaluate the clinical equivalence and the general tolerability of two different subcutaneous hCG preparations (hCG-IBSA, IBSA vs Ovitrelle, Serono) when administered to patients undergoing IVF.
Detailed Description This is a prospective, multicenter, randomized, investigator blind, parallel group, active control, phase III clinical trial. Patients meeting the eligibility requirements of the study will be randomly assigned to receive either the test drug (hCG-IBSA, IBSA) or the reference drug (Ovitrelle, Serono). Investigators will be blinded by not allowing them to have any contact with the study medications (supplied in boxes labeled in a manner that does not reveal the content of the boxes), and requesting that patients do not make any statements to the investigator that might indicate the treatment to which they were assigned. Equivalence testing with regard to the primary outcome variable will establish whether the two treatments are indeed similarly effective.
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: hCG-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
Actual Study Completion Date  ICMJE December 2008
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • >/=18 and < 40 years old;
  • BMI between 18 and 30 kg/m2;
  • less than 3 previous completed cycles;
  • both ovaries present;
  • regular menstrual cycle of 25-35 days;
  • infertility attributable to a tubal factor, American Fertility Society grade I or II endometriosis, male factor or unexplained factor.
  • within 12 months of the beginning of the study, uterine cavity consistent with expected normal function as assessed through hysterosalpingogram, sonohystrogram or hysteroscopic examination;
  • basal FSH level less than 10 IU/L;
  • criteria for hCG administration fulfilled (at least 2 follicles with a diameter of 16 mm or more, with acceptable serum E2 concentration).
  • a male partner with semen analysis within the past 6 months showing acceptable values of seminal parameters, defined as > 3x10 exp 6 spermatozoa/ml;
  • qualified to receive 150 - 300 IU FSH as starting dose.

Exclusion Criteria:

  • age < 18 and > o = 40 years;
  • primary ovarian failure or women known as poor responders (i.e. requiring more than 300 IU of FSH as a starting dose in previous treatment cycles or having less than 3 oocytes retrieved, or with an E2 serum concentration < 3'000 pmol/L);
  • ovarian cysts > 20 mm, or enlargement not due to polycystic ovarian syndrome;
  • patients affected by pathologies associated with any contraindication of being pregnant;
  • hypersensitivity to the study medication;
  • any bleeding since stimulation;
  • uncontrolled thyroid or adrenal dysfunction;
  • neoplasias;
  • severe impairment of the renal and/or hepatic functions;
  • use of concomitant medication that might interfere with study evaluations (e.g. nonstudy hormonal medications, prostaglandin inhibitors, psychotropic agents);
  • more than 18 days of FSH stimulation.
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years to 40 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Switzerland
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00335569
Other Study ID Numbers  ICMJE 04CH/HCG02
Has Data Monitoring Committee No
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
Principal Investigator: Dominique de Ziegler, Prof. Départements de Gynécologie/Obstétrique et de Pédiatrie
PRS Account IBSA Institut Biochimique SA
Verification Date May 2011

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