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

Last updated: July 30, 2014
Sponsor: Merck KGaA, Darmstadt, Germany
Overall Status: Completed

Phase

3

Condition

Infertility

Treatment

N/A

Clinical Study ID

NCT01081652
IMP 25347
  • Female

Study 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.

Eligibility Criteria

Inclusion

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

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

Study Design

Total Participants: 238
Study Start date:
May 01, 2004
Estimated Completion Date:
May 31, 2005

Study Description

This was an open-label, randomized, comparative, multicentric, phase III study to evaluate the safety and efficacy of Crinone 8% in comparison with progesterone 60 mg intramuscular administered once a day in luteal phase support in Chinese female subjects undergoing IVF/ET. The study planned to enroll 200 female subjects who underwent pituitary down-regulation as per each center's normal practice prior to and during stimulation of multiple follicular development. The progesterone administration was started on the day of ET. Randomisation was performed on the day of ET. If pregnancy was confirmed on day 14 of the progesterone administration, the progesterone was continued for another 45 days. The subjects were followed up and the treatment outcome (negative pregnancy test or pregnancy) was recorded.

Connect with a study center

  • Peking University 3rd Hopistal

    Beijing, 100191
    China

    Site Not Available

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.