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

Phase 4

• Conditions: IVF - Luteal Phase Support After Embryo Transfer
• Interventions: Drug: Progesterone

• Registration Number: NCT00708539
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2006-04
• Study First Submitted: 2008-06-27
• Status Verified: 2008-07
• Study First Submitted QC: 2008-07-01
• Last Update Submitted: 2008-07-01
• Study First Posted: 2008-07-02
• Last Update Posted: 2008-07-02
• Primary Completion: 2008-12
• Study Completion: 2008-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 2686

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	Progesterone	Crinone vaginal gel 8% 90 mg once daily
2	Progesterone	Progesterone mic 400 mg three times daily

Primary Outcome Measures

Name	Time	Method
Equivalence in ongoing pregnancy per embryo transfer between the two groups	week 5 after embryo tranfer

Secondary Outcome Measures

Name	Time	Method
Convenience for the patient	the treatment period (from the day of embryo transfer and 19 days ahead)

Trial Locations

Locations (17)

Reproduktionscentrum, Sahlgrenska; 🇸🇪 Göteborg, Sweden

Reproduktionscentrum; 🇸🇪 Stockholm, Sweden

Norrlandsuniversitets sjukhus; 🇸🇪 Umeå, Sweden

RMC; 🇸🇪 Malmö, Sweden

Karolinska; 🇸🇪 Huddinge, Sweden

Faurskov fertility clinic; 🇩🇰 Aalborg, Denmark

Brædstrup Sygehus; 🇩🇰 Brædstrup, Denmark

Hvidovre Hospital; 🇩🇰 Hvidovre, Denmark

Dronninglund sygehus; 🇩🇰 Dronninglund, Denmark

Dansk Fertilitetsklinik; 🇩🇰 Frederiksberg, Denmark

Roskilde Sygehus; 🇩🇰 Roskilde, Denmark

Skive sygehus; 🇩🇰 Skive, Denmark

Herlev Hospital; 🇩🇰 Herlev, Denmark

Holbæk Sygehus; 🇩🇰 Holbæk, Denmark

Rigshospitalet; 🇩🇰 København Ø, Denmark

Odense OUH; 🇩🇰 Odense, Denmark

Odense IVF; 🇩🇰 Odense, Denmark