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

Verified by: Nordica Fertility Clinic, July 2008
First Received: June 27, 2008 | Last Updated: July 1, 2008 | Phase: Phase 4 | Start Date: April 2006
Overall Status: Recruiting | Estimated Enrollment: 2686
  • …
  • Tell a FriendPrint

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...

Brief Summary

Official Title: “A Prospective Randomized Multicentre Study to Compare Crinone 8% Once Daily Versus Other Vaginal Progesterone.”

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.

  • Study Type: Interventional
  • Study Design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment
  • Study Primary Completion Date: December 2008

Intervention(s) in this Clinical Trial

  • Drug: progesterone
    • 90 mg, vaginal, once daily
  • Drug: Progesterone
    • 200 mg, vaginal, three times daily used in Denmark, 400 mg, vaginal, three times daily used in Sweden

Arms, Groups and Cohorts in this Clinical Trial

  • Active Comparator: 1
    • Crinone vaginal gel 8% 90 mg once daily
  • Active Comparator: 2
    • Progesterone mic 400 mg three times daily

Outcome Measures for this Clinical Trial

Primary Measures

  • Equivalence in ongoing pregnancy per embryo transfer between the two groups
    • Time Frame: week 5 after embryo tranfer
      Safety Issue?: No

Secondary Measures

  • Convenience for the patient
    • Time Frame: the treatment period (from the day of embryo transfer and 19 days ahead)
      Safety Issue?: No

Criteria for Participation in this Clinical Trial

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

Gender Eligibility for this Clinical Trial: Female

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: 40 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Clinical Trial Investigator Information

Lead Investigator: Nordica Fertility Clinic Other

Overall Clinical Trial Officials and Contacts

Svend Lindenberg Principal Investigator Nordica Fertilityclinic  

Overall Contact: Svend Lindenberg 004533257000 svend@lindenberg.dk

Additional Information

Information obtained from ClinicalTrials.gov on February 12, 2012

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00708539

Study ID Number: 25921

ClinicalTrials.gov Identifier: NCT00708539

Health Authority: Denmark: Danish Dataprotection Agency

  • …
  • Tell a FriendPrint

Clinical Trials content is provided directly by the U.S. National Institutes of Health via ClinicalTrials.gov and is not reviewed separately by ClinicalTrialsFeeds.org. Every page of specific clinical trials information contains a unique identifier which can be used to find further details directly from the National Institutes of Health.

The URL of this page is:
http://clinicaltrialsfeeds.org/clinical-trials/show/NCT00708539