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

July 1, 2008 updated by: Nordica Fertility Clinic
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 Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

2686

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Aalborg, Denmark, 9000
        • Terminated
        • Faurskov fertility clinic
      • Brædstrup, Denmark, 8740
        • Recruiting
        • Brædstrup Sygehus
        • Contact:
          • Finn Hald
      • Dronninglund, Denmark, 9330
        • Recruiting
        • Dronninglund sygehus
        • Contact:
          • Michael Aasted
      • Frederiksberg, Denmark, 2000
        • Recruiting
        • Dansk Fertilitetsklinik
        • Contact:
          • Hans Krogh
      • Herlev, Denmark, 2730
        • Recruiting
        • Herlev Hospital
        • Contact:
          • Jan Blaabjerg
      • Holbæk, Denmark, 4300
        • Recruiting
        • Holbæk Sygehus
        • Contact:
          • Helle E Bredkær
      • Hvidovre, Denmark, 2650
        • Recruiting
        • Hvidovre Hospital
        • Contact:
          • Helle Meinertz
      • København Ø, Denmark, 2100
        • Recruiting
        • Rigshospitalet
        • Contact:
          • Anders N Andersen
      • Odense, Denmark, 5000
        • Recruiting
        • Odense IVF
        • Contact:
          • Sven Rex
      • Odense, Denmark, 5000
        • Recruiting
        • Odense OUH
        • Contact:
          • Lars Westergaard
      • Roskilde, Denmark, 4000
        • Recruiting
        • Roskilde Sygehus
        • Contact:
          • Anette Lindhard
      • Skive, Denmark, 7800
        • Recruiting
        • Skive sygehus
        • Contact:
          • Peter Humaidan
  • Sweden
      • Göteborg, Sweden
        • Recruiting
        • Reproduktionscentrum, Sahlgrenska
      • Huddinge, Sweden
        • Recruiting
        • Karolinska
      • Malmö, Sweden
        • Recruiting
        • RMC
      • Stockholm, Sweden
        • Recruiting
        • Reproduktionscentrum
      • Umeå, Sweden
        • Recruiting
        • Norrlandsuniversitets sjukhus

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 40 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 1
Crinone vaginal gel 8% 90 mg once daily
Drug: progesterone
90 mg, vaginal, once daily
Other Names:
  • crinone 8%
Active Comparator: 2
Progesterone mic 400 mg three times daily
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Equivalence in ongoing pregnancy per embryo transfer between the two groups
Time Frame: week 5 after embryo tranfer
week 5 after embryo tranfer

Secondary Outcome Measures

Outcome Measure
Time Frame
Convenience for the patient
Time Frame: the treatment period (from the day of embryo transfer and 19 days ahead)
the treatment period (from the day of embryo transfer and 19 days ahead)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Nordica Fertility Clinic

Collaborators

Merck Serono International SA

Investigators

  • Principal Investigator: Svend Lindenberg, Nordica Fertilityclinic
  • Principal Investigator: Svend Lindenberg, Nordica Fertility Clinic

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2006

Primary Completion (Anticipated)

December 1, 2008

Study Completion (Anticipated)

December 1, 2008

Study Registration Dates

First Submitted

June 27, 2008

First Submitted That Met QC Criteria

July 1, 2008

First Posted (Estimate)

July 2, 2008

Study Record Updates

Last Update Posted (Estimate)

July 2, 2008

Last Update Submitted That Met QC Criteria

July 1, 2008

Last Verified

July 1, 2008

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 25921
  • Eudra CT nr.2005-001248-22

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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