A Study Using Micronised Progesterone (Crinone® 8%) in the Luteal Phase Support of Women Undergoing in Vitro Fertilisation (IVF) and Embryo Transfer (ET)

• Status: Completed
• Trial end date: 2005-05-01
• Target enrollment: 0
• Participant gender: Female

Summary

This was an open-label, randomized, comparative, phase III study to evaluate the safety and efficacy of Crinone 8% in comparison with progesterone 60 mg intramuscular (i.m.) administered once a day in luteal phase support in 200 Chinese female subjects undergoing IVF/ET.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Merck KGaA; Merck KGaA, Darmstadt, Germany
• Treatments: Progesterone

Criteria

Inclusion Criteria:

• Patient has given written informed consent

• BMI < 25 kg/m2

• Age < 36 years

• <3 prior ART cycles (IVF, ICSI and related procedures)

• Infertility

• Regular spontaneous ovulatory menstrual cycles

Exclusion Criteria:

• Habitual abortion

• Hydrosalpinges

• History of past poor response to COH

• Patients with serious arterial, lung, hepatic and renal diseases

• Hepatic and renal impairment