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

Information source: Merck KGaA
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Infertility

Intervention: Micronised Progesterone (Drug); Progesterone (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Merck KGaA

Official(s) and/or principal investigator(s):
Huafei Li, Study Director, Affiliation: Serono Pharmaceutical Limited

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.

Clinical Details

Official title: An Open, Randomized, Comparative, Phase III Study Using Micronised Progesterone (Crinone 8%) in the Luteal Phase Support of Women Undergoing in Vitro Fertilization and Embryo Transfer (IVF/ET)

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome:

The difference in hCG positive rate in the two arms 14 days after embryo transfer

The difference in pregnancy rates in the two arms 30 and 60 days after embryo transfer

The difference in implantation rate in the two arms 30 days after embryo transfer

Detailed 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.

Eligibility

Minimum age: N/A. Maximum age: N/A. Gender(s): Female.

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

Locations and Contacts

Peking University 3rd Hopistal, Beijing 100191, China
Additional Information

Starting date: May 2004
Last updated: July 30, 2014

Page last updated: August 23, 2015

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