Overview

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