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A Multicentre, Randomised, Double-blind, Placebo-controlled Proof of Concept Study to Compare the Efficacy and Safety of r-hLIF (Emfilermin) for Improving Embryo Implantation Following in Vitro Fertilization (IVF) and Embryo Transfer (ET) in Women With Recurrent Implantation Failure

NCT00504608 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 150

Last updated 2017-01-04

No results posted yet for this study

Summary

The primary objective of the study was to provide further clinical and statistical evidence of the efficacy of r-hLIF, in comparison with placebo, administered during the luteal phase after IVF and ET for improving embryo implantation in infertile women with a history of at least 2 implantation failures following transfer of fresh embryos. The secondary objective of the study was to assess the safety profile of r-hLIF in the proposed indication.

Conditions

  • Infertility Implantation Failure

Interventions

DRUG

Emfilermin, recombinant human leukemia inhibitory factor (r-hLIF)

Sponsors & Collaborators

  • Merck KGaA, Darmstadt, Germany

    lead INDUSTRY

Principal Investigators

  • Paul Barrière, M.D. · Bourn Hall Clinic, Bourn Hall, High Street, Bourn, Cambridge CB3 7TR

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
21 Years
Max Age
37 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2003-04-30
Primary Completion
2004-04-30
Completion
2004-04-30

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00504608 on ClinicalTrials.gov