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

Information source: Nordica Fertility Clinic
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: IVF - Luteal Phase Support After Embryo Transfer

Intervention: progesterone (Drug); Progesterone (Drug)

Phase: Phase 4

Status: Recruiting

Sponsored by: Nordica Fertility Clinic

Official(s) and/or principal investigator(s):
Svend Lindenberg, Principal Investigator, Affiliation: Nordica Fertilityclinic
Svend Lindenberg, Principal Investigator, Affiliation: Nordica Fertility Clinic

Overall contact:
Svend Lindenberg, Phone: 004533257000, Email: svend@lindenberg.dk

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.

Clinical Details

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

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Primary outcome: Equivalence in ongoing pregnancy per embryo transfer between the two groups

Secondary outcome: Convenience for the patient

Eligibility

Minimum age: 18 Years. Maximum age: 40 Years. Gender(s): Female.

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

Locations and Contacts

Svend Lindenberg, Phone: 004533257000, Email: svend@lindenberg.dk

Faurskov fertility clinic, Aalborg 9000, Denmark; Terminated

Brædstrup Sygehus, Brædstrup 8740, Denmark; Recruiting
Finn Hald

Dronninglund sygehus, Dronninglund 9330, Denmark; Recruiting
Michael Aasted

Dansk Fertilitetsklinik, Frederiksberg 2000, Denmark; Recruiting
Hans Krogh

Herlev Hospital, Herlev 2730, Denmark; Recruiting
Jan Blaabjerg

Holbæk Sygehus, Holbæk 4300, Denmark; Recruiting
Helle E Bredkær

Hvidovre Hospital, Hvidovre 2650, Denmark; Recruiting
Helle Meinertz

Rigshospitalet, København Ø 2100, Denmark; Recruiting
Anders N Andersen

Odense IVF, Odense 5000, Denmark; Recruiting
Sven Rex

Odense OUH, Odense 5000, Denmark; Recruiting
Lars Westergaard

Roskilde Sygehus, Roskilde 4000, Denmark; Recruiting
Anette Lindhard

Skive sygehus, Skive 7800, Denmark; Recruiting
Peter Humaidan

Reproduktionscentrum, Sahlgrenska, Göteborg, Sweden; Recruiting

Karolinska, Huddinge, Sweden; Recruiting

RMC, Malmö, Sweden; Recruiting

Reproduktionscentrum, Stockholm, Sweden; Recruiting

Norrlandsuniversitets sjukhus, Umeå, Sweden; Recruiting

Additional Information

Starting date: April 2006
Last updated: July 1, 2008

Page last updated: August 23, 2015

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