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A Prospective Randomized Multicentre Study to Compare Crinone 8% Once Daily Versus Other Vaginal Progesterone.

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ClinicalTrials.gov Identifier: NCT00708539
Recruitment Status : Unknown
Verified July 2008 by Nordica Fertility Clinic.
Recruitment status was:  Recruiting
First Posted : July 2, 2008
Last Update Posted : July 2, 2008
Sponsor:
Collaborator:
Merck Serono International SA
Information provided by:
Nordica Fertility Clinic

Tracking Information
First Submitted Date  ICMJE June 27, 2008
First Posted Date  ICMJE July 2, 2008
Last Update Posted Date July 2, 2008
Study Start Date  ICMJE April 2006
Estimated Primary Completion Date December 2008   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 1, 2008)
Equivalence in ongoing pregnancy per embryo transfer between the two groups [ Time Frame: week 5 after embryo tranfer ]
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: July 1, 2008)
Convenience for the patient [ Time Frame: the treatment period (from the day of embryo transfer and 19 days ahead) ]
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 A Prospective Randomized Multicentre Study to Compare Crinone 8% Once Daily Versus Other Vaginal Progesterone.
Official Title  ICMJE A Prospective Randomized Multicentre Study to Compare Crinone 8% Once Daily Versus Other Vaginal Progesterone.
Brief Summary To compare the effect of Crinone 8% administered once daily versus other vaginal progesterone in terms of ongoing pregnancy rate 5 weeks after embryo transfer as well as patient convenience.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE IVF - Luteal Phase Support After Embryo Transfer
Intervention  ICMJE
  • Drug: progesterone
    90 mg, vaginal, once daily
    Other Name: crinone 8%
  • Drug: Progesterone
    200 mg, vaginal, three times daily used in Denmark, 400 mg, vaginal, three times daily used in Sweden
    Other Names:
    • Progestan in Denmark
    • Progesterone mic in Sweden
Study Arms  ICMJE
  • Active Comparator: 1
    Crinone vaginal gel 8% 90 mg once daily
    Intervention: Drug: progesterone
  • Active Comparator: 2
    Progesterone mic 400 mg three times daily
    Intervention: Drug: Progesterone
Publications * Not Provided

*   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
Estimated Enrollment  ICMJE
 (submitted: July 1, 2008)
2686
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2008
Estimated Primary Completion Date December 2008   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • 18-40 years
  • Regular menstrual cyclus 25-35 days
  • both ovaries present
  • No more than 2 previous IVF attempts
  • Have given written informed consent

Exclusion Criteria:

  • More than 2 previous attempts
  • Known drug abuse
  • Known allergies to the study medication
  • No embryo transfer performed in the study cycle
  • Previous participating in the study
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 Denmark,   Sweden
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00708539
Other Study ID Numbers  ICMJE 25921
Eudra CT nr.2005-001248-22
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Professor Svend Lindenberg, Nordica fertility clinic
Study Sponsor  ICMJE Nordica Fertility Clinic
Collaborators  ICMJE Merck Serono International SA
Investigators  ICMJE
Principal Investigator: Svend Lindenberg Nordica Fertilityclinic
Principal Investigator: Svend Lindenberg Nordica Fertility Clinic
PRS Account Nordica Fertility Clinic
Verification Date July 2008

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