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Sponsored by: |
EMD Serono |
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Information provided by: | EMD Serono |
ClinicalTrials.gov Identifier: | NCT00504608 |
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.
Condition | Intervention | Phase |
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Infertility, Implantation Failure. |
Drug: Emfilermin, recombinant human leukemia inhibitory factor (r-hLIF) |
Phase I Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment |
Official Title: | 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 |
Ages Eligible for Study: | 21 Years to 37 Years |
Genders Eligible for Study: | Female |
Inclusion Criteria:
History of:
Exclusion Criteria:
Study ID Numbers: | 24070 |
Study First Received: | July 18, 2007 |
Last Updated: | July 18, 2007 |
ClinicalTrials.gov Identifier: | NCT00504608 |
Health Authority: | Australia: National Health and Medical Research Council; Belgium: Federal Agency for Medicinal Products and Health Products; France: Ministry of Health; Israel: Ministry of Health; Spain: Ministry of Health; Sweden: Medical Products Agency; United Kingdom: National Health Service |
Genital Diseases, Female Infertility Genital Diseases, Male Recurrence |