Multi-Center, Randomized, Open-Label, Parallel Group Study of a Vaginal Micronized Progesterone Tablet (Endometrin®) Compared to Crinone 8% Vaginal Gel in Female Patients Undergoing In-Vitro Fertilization (IVF)

Phase 3

Completed

• Conditions: Fertility
• Interventions: Drug: Crinone; Drug: Endometrin

• Registration Number: NCT00296478
• Lead Sponsor: Ferring Pharmaceuticals

Brief Summary

This multicenter, randomized, open-label study will be performed in approximately 990 healthy females undergoing IVF. Each study center will follow their study center standard practice for IVF unless otherwise noted in this protocol. The study centers will be provided with the medications for down regulation, stimulation and ovulation induction. The subjects will be randomized to study medication on the day of oocyte retrieval or the day following and will continue treatment for up to 10 weeks. The subjects with a confirmed pregnancy will be required to return to the clinic several times during the course of the 10 week treatment period for serum pregnancy tests and transvaginal ultrasounds to monitor the pregnancy.

Detailed Description

This multicenter, randomized, open-label study will be performed in approximately 990 healthy females undergoing IVF. Each study center will follow their study center standard practice for IVF unless otherwise noted in this protocol. The study centers will be provided with the medications for down regulation, stimulation and ovulation induction. The subjects will be randomized to study medication on the day of oocyte retrieval or the day following and will continue treatment for up to 10 weeks. The subjects with a confirmed pregnancy will be required to return to the clinic several times during the course of the 10 week treatment period for serum pregnancy tests and transvaginal ultrasounds to monitor the pregnancy.

Study Timeline

• Study Start: 2005-07
• Study First Submitted: 2006-02-23
• Study First Submitted QC: 2006-02-23
• Study First Posted: 2006-02-27
• Primary Completion: 2006-04
• Study Completion: 2006-07
• Status Verified: 2011-05
• Last Update Submitted: 2011-05-18
• Last Update Posted: 2011-05-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 1211

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
3	Crinone	Crinone
1	Endometrin	Endometrin 100mg BID
2	Endometrin	Endometrin 100mg TID

Primary Outcome Measures

Name	Time	Method
Ongoing pregnancy.	6 weeks

Secondary Outcome Measures

Name	Time	Method
Biochemical pregnancy, clinical pregnancy, pregnancy outcome.	1 year