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Sponsored by: |
EMD Serono |
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Information provided by: | EMD Serono |
ClinicalTrials.gov Identifier: | NCT00504530 |
This study was designed to obtain pilot clinical evidence of the efficacy, safety and acceptability of r-hLIF administered during the luteal phase after IVF/intra-cytoplasmic sperm injection (ICSI) and ET for improving embryo implantation in infertile women with a history of at least three implantation failures following ART. Based on LIF expression patterns and experimental data from animal research a role of LIF in embryo implantation is anticipated.
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 Randomised, Double-Blind, Placebo Controlled, Proof of Concept Study to Assess the Efficacy, Safety and Acceptability of r-hLIF for Improving Embryo Implantation Following in Vitro Fertilisation (IVF) and Embryo Transfer (ET) in Women With Recurrent Implantation Failure. |
Enrollment: | 50 |
Study Start Date: | September 2001 |
Study Completion Date: | April 2002 |
Ages Eligible for Study: | 21 Years to 36 Years |
Genders Eligible for Study: | Female |
Inclusion Criteria:
Exclusion Criteria:
Responsible Party: | ( Merck Serono International SA, an affiliate of Merck KGaA Darmstadt, Germany ) |
Study ID Numbers: | 23079 |
Study First Received: | July 18, 2007 |
Last Updated: | January 4, 2008 |
ClinicalTrials.gov Identifier: | NCT00504530 |
Health Authority: | United Kingdom: National Health Service |
Genital Diseases, Female Infertility Genital Diseases, Male Recurrence |