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: Treatment, Randomized, Single Blind (Outcomes Assessor), Active Control, Parallel Assignment, Efficacy Study

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

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

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

Lead Sponsor: Nordica Fertility Clinic

Overall Clinical Trial Officials and Contacts

Svend Lindenberg Principal Investigator Nordica Fertilityclinic  

Overall Contact: Svend Lindenberg 004533257000 svend@lindenberg.dk

Information obtained from ClinicalTrials.gov on August 27, 2008

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