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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

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.

Condition or disease Intervention/treatment Phase
IVF - Luteal Phase Support After Embryo Transfer Drug: progesterone Drug: Progesterone Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 2686 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Prospective Randomized Multicentre Study to Compare Crinone 8% Once Daily Versus Other Vaginal Progesterone.
Study Start Date : April 2006
Estimated Primary Completion Date : December 2008
Estimated Study Completion Date : December 2008

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: 1
Crinone vaginal gel 8% 90 mg once daily
Drug: progesterone
90 mg, vaginal, once daily
Other Name: 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




Primary Outcome Measures :
  1. Equivalence in ongoing pregnancy per embryo transfer between the two groups [ Time Frame: week 5 after embryo tranfer ]

Secondary Outcome Measures :
  1. Convenience for the patient [ Time Frame: the treatment period (from the day of embryo transfer and 19 days ahead) ]


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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00708539


Contacts
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Contact: Svend Lindenberg 004533257000 svend@lindenberg.dk

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

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Responsible Party: Professor Svend Lindenberg, Nordica fertility clinic
ClinicalTrials.gov Identifier: NCT00708539     History of Changes
Other Study ID Numbers: 25921
Eudra CT nr.2005-001248-22
First Posted: July 2, 2008    Key Record Dates
Last Update Posted: July 2, 2008
Last Verified: July 2008

Additional relevant MeSH terms:
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Progesterone
Progestins
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs