A Prospective Randomized Multicentre Study to Compare Crinone 8% Once Daily Versus Other Vaginal Progesterone.
2 other identifiers
interventional
2,686
2 countries
17
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started Apr 2006
Typical duration for phase_4
17 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2006
CompletedFirst Submitted
Initial submission to the registry
June 27, 2008
CompletedFirst Posted
Study publicly available on registry
July 2, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2008
CompletedJuly 2, 2008
July 1, 2008
2.7 years
June 27, 2008
July 1, 2008
Conditions
Outcome Measures
Primary Outcomes (1)
Equivalence in ongoing pregnancy per embryo transfer between the two groups
week 5 after embryo tranfer
Secondary Outcomes (1)
Convenience for the patient
the treatment period (from the day of embryo transfer and 19 days ahead)
Study Arms (2)
1
ACTIVE COMPARATORCrinone vaginal gel 8% 90 mg once daily
2
ACTIVE COMPARATORProgesterone mic 400 mg three times daily
Interventions
Eligibility Criteria
You may qualify if:
- years
- Regular menstrual cyclus 25-35 days
- both ovaries present
- No more than 2 previous IVF attempts
- Have given written informed consent
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Nordica Fertility Cliniclead
- Merck Serono International SAcollaborator
Study Sites (17)
Faurskov fertility clinic
Aalborg, 9000, Denmark
Brædstrup Sygehus
Brædstrup, 8740, Denmark
Dronninglund sygehus
Dronninglund, 9330, Denmark
Dansk Fertilitetsklinik
Frederiksberg, 2000, Denmark
Herlev Hospital
Herlev, 2730, Denmark
Holbæk Sygehus
Holbæk, 4300, Denmark
Hvidovre Hospital
Hvidovre, 2650, Denmark
Rigshospitalet
København Ø, 2100, Denmark
Odense IVF
Odense, 5000, Denmark
Odense OUH
Odense, 5000, Denmark
Roskilde Sygehus
Roskilde, 4000, Denmark
Skive sygehus
Skive, 7800, Denmark
Reproduktionscentrum, Sahlgrenska
Gothenburg, Sweden
Karolinska
Huddinge, Sweden
RMC
Malmo, Sweden
Reproduktionscentrum
Stockholm, Sweden
Norrlandsuniversitets sjukhus
Umeå, Sweden
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Svend Lindenberg
Nordica Fertilityclinic
- PRINCIPAL INVESTIGATOR
Svend Lindenberg
Nordica Fertility Clinic
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
June 27, 2008
First Posted
July 2, 2008
Study Start
April 1, 2006
Primary Completion
December 1, 2008
Study Completion
December 1, 2008
Last Updated
July 2, 2008
Record last verified: 2008-07