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Comparison Between Recombinant Versus Urinary hCG for Ovulation Induction in High Responders

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ClinicalTrials.gov Identifier: NCT00415766
Recruitment Status : Unknown
Verified January 2016 by Eugonia.
Recruitment status was:  Active, not recruiting
First Posted : December 25, 2006
Last Update Posted : January 20, 2016
Sponsor:
Information provided by (Responsible Party):
Eugonia

Tracking Information
First Submitted Date  ICMJE December 22, 2006
First Posted Date  ICMJE December 25, 2006
Last Update Posted Date January 20, 2016
Study Start Date  ICMJE June 2013
Actual Primary Completion Date December 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 22, 2015)
Percentage of mature oocytes [ Time Frame: Day of oocyte retrieval (Day 0) ]
Percentage MII/COCs
Original Primary Outcome Measures  ICMJE
 (submitted: December 23, 2006)
Level of hCG on day of oocyte retrieval
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: December 22, 2015)
  • Positive test per embryo transfer [ Time Frame: 15 days post oocyte retrieval ]
  • Clinical pregnancy per embryo transfer [ Time Frame: 7 weeks of gestation ]
  • Ongoing pregnancy per embryo transfer [ Time Frame: 12 weeks of gestation ]
  • Level of serum hCG on day of oocyte retrieval [ Time Frame: Day of oocyte retrieval ]
  • Number of oocytes (COC) retrieved [ Time Frame: Day of oocyte retrieval ]
  • Number of mature oocytes (MII) [ Time Frame: Day of oocyte retrieval ]
  • Oocyte retrieval rate [ Time Frame: Day of oocyte retrieval (Day 0) ]
    Number of oocytes retrieved/number of follicles on the day of triggering final oocyte maturation
  • Incidence of severe early OHSS [ Time Frame: up to Day 5 post oocyte retrieval ]
Original Secondary Outcome Measures  ICMJE
 (submitted: December 23, 2006)
  • Biochemical pregnancy per embryo transfer
  • Clinical pregnancy per embryo transfer
  • Ongoing pregnancy per embryo transfer
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Comparison Between Recombinant Versus Urinary hCG for Ovulation Induction in High Responders
Official Title  ICMJE Recombinant hCG (Ovitrelle) Vesrus Urinary hCG (Pregnyl) for Triggering Final Oocyte Maturation in High Responders
Brief Summary The purpose of this study is to compare the clinical outcomes of recombinant human chorionic gonadotrophin (rHCG) and urinary HCG (uHCG) in patients undergoing IVF cycles.
Detailed Description Urinary human chorionic gonadotrophin (u-hCG) has been widely used to induce final oocyte maturation and to trigger ovulation in assisted conception. Recombinant technology has allowed the production of r-hCG inj which all urinary contaminants are absent. Hence, this would allow the safe subcutaneous administration of a compound with less batch-to-batch variation. This study will investigate the effectiveness of the recombinant hCG compared to the currently used urinary hCG.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Infertility
Intervention  ICMJE
  • Drug: rHCG 250ug
    Injection of 250 ug Ovitrelle to trigger final oocyte maturation
    Other Name: Ovitrelle
  • Drug: uHCG 5000 IU
    Injection of 5000 IU Pregnyl to trigger final oocyte maturation
    Other Name: Pregnyl 5000 IU
  • Drug: uHCG 7500 IU
    Injection of 7500 IU Pregnyl to trigger final oocyte maturation
    Other Name: Pregnyl 7500 IU
Study Arms  ICMJE
  • Active Comparator: rHCG 250 ug
    Injection of 250 ug Ovitrelle to trigger final oocyte maturation
    Intervention: Drug: rHCG 250ug
  • Active Comparator: uHCG 5000 IU
    Injection of 5000 IU Pregnyl to trigger final oocyte maturation
    Intervention: Drug: uHCG 5000 IU
  • Active Comparator: uHCG 7500 IU
    Injection of 7500 IU Pregnyl to trigger final oocyte maturation
    Intervention: Drug: uHCG 7500 IU
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 Unknown status
Actual Enrollment  ICMJE
 (submitted: December 22, 2015)
150
Original Enrollment  ICMJE
 (submitted: December 23, 2006)
200
Estimated Study Completion Date  ICMJE July 2016
Actual Primary Completion Date December 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • At least 14 follicles >11mm on the day of triggering final oocyte maturation
  • Pretreated with GnRH antagonist protocol

Exclusion Criteria:

  • Poor responders
  • Women with 25 or more follicles on the day of trigger
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years to 39 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Greece
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00415766
Other Study ID Numbers  ICMJE ovitrelle vs pregnyl
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Eugonia
Study Sponsor  ICMJE Eugonia
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Tryfon Lainas, PhD Eugonia
PRS Account Eugonia
Verification Date January 2016

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