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

IVF - Luteal Phase Support After Embryo Transfer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00708539
• Other study ID #: 25921
• Secondary ID: Eudra CT nr.2005
• Status: Recruiting
• Phase: Phase 4
• First received: June 27, 2008
• Last updated: July 1, 2008
• Start date: April 2006
• Est. completion date: December 2008

Study information

• Verified date: July 2008
• Source: Nordica Fertility Clinic
• Contact: Svend Lindenberg
• Phone: 004533257000
• Email: svend[@]lindenberg.dk
• Is FDA regulated: No
• Health authority: Denmark: Danish Dataprotection AgencyDenmark: Danish Medicines AgencyDenmark: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 2686
• Est. completion date: December 2008
• Est. primary completion date: December 2008
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 40 Years

Eligibility

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 Design

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

Related Conditions & MeSH terms

• IVF - Luteal Phase Support After Embryo Transfer

Intervention

Drug:
• progesterone
90 mg, vaginal, once daily
• Progesterone
200 mg, vaginal, three times daily used in Denmark, 400 mg, vaginal, three times daily used in Sweden

Locations

Country	Name	City	State
Denmark	Faurskov fertility clinic	Aalborg
Denmark	Brædstrup Sygehus	Brædstrup
Denmark	Dronninglund sygehus	Dronninglund
Denmark	Dansk Fertilitetsklinik	Frederiksberg
Denmark	Herlev Hospital	Herlev
Denmark	Holbæk Sygehus	Holbæk
Denmark	Hvidovre Hospital	Hvidovre
Denmark	Rigshospitalet	København Ø
Denmark	Odense IVF	Odense
Denmark	Odense OUH	Odense
Denmark	Roskilde Sygehus	Roskilde
Denmark	Skive sygehus	Skive
Sweden	Reproduktionscentrum, Sahlgrenska	Göteborg
Sweden	Karolinska	Huddinge
Sweden	RMC	Malmö
Sweden	Reproduktionscentrum	Stockholm
Sweden	Norrlandsuniversitets sjukhus	Umeå

Sponsors (2)

Lead Sponsor	Collaborator
Nordica Fertility Clinic	Merck Serono International SA

Countries where clinical trial is conducted

Denmark,  Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Equivalence in ongoing pregnancy per embryo transfer between the two groups		week 5 after embryo tranfer	No
Secondary	Convenience for the patient		the treatment period (from the day of embryo transfer and 19 days ahead)	No