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

Nordica Fertility Clinic

Status and phase: Unknown; Phase 4

Conditions: IVF - Luteal Phase Support After Embryo Transfer

Treatments: Drug: progesterone; Drug: Progesterone

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00708539

Eudra CT nr.2005-001248-22

25921

Details and patient eligibility

About

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.

Enrollment: 2,686 estimated patients

Sex: Female

Ages: 18 to 40 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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2,686 participants in 2 patient groups

1

Active Comparator group

Description:

Crinone vaginal gel 8% 90 mg once daily

Treatment:

Drug: progesterone

2

Active Comparator group

Description:

Progesterone mic 400 mg three times daily

Treatment:

Drug: Progesterone