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ISRCTN
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ISRCTN71286562
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ClinicalTrials.gov identifier
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Public title
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Randomised controlled trial of prophylactic antibiotics at the time of oocyte retrieval and their impact on incidence of bacterial contamination of the catheter used for embryo transfer, embryo implantation and pregnancy rates.
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Scientific title
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Acronym
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N/A
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Serial number at source
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N0013146096
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Study hypothesis
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Impact of prophylactic antibiotics at the time of oocyte retrieval on incidence of bacterial contamination of the catheter used for embryo transfer, embryo implantation and pregnancy rates.
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Lay summary
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Ethics approval
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Added 25/06/10:
Received from South East London REC 1 (formerly Guy's Research Ethics Committee)
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Study design
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Randomised controlled trial
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Countries of recruitment
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United Kingdom
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Disease/condition/study domain
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Embryo implantation
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Participants - inclusion criteria
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Patients undergoing embryo transfer without any indication of pelvic infection.
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Participants - exclusion criteria
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1. Patients allergic to penicillin
2. Patients previously in trial
3. Patients who required antibiotics at the time of egg collection
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Anticipated start date
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01/03/2004
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Anticipated end date
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01/05/2004
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Status of trial
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Completed |
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Patient information material
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Target number of participants
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350
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Interventions
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Randomised controlled trial of patients into antibiotics or no treatment.
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Primary outcome measure(s)
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Incidence of bacterial contamination of mock catheter and embryo transfer catheter, embryo implantation and pregnancy rates.
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Secondary outcome measure(s)
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Not provided at time of registration
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Sources of funding
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Guy's and St. Thomas' NHS Foundation Trust (UK) - NHS R&D Support Funding
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Trial website
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Publications
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2006 results in http://www.ncbi.nlm.nih.gov/pubmed/16832124
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Contact name
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Dr
Yakoub A
Khalaf
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Address
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Guy's & St Thomas' NHS Foundation Trust
Assisted Conception Unit
4th Floor, Thomas' Guy House
Guy's Hospital, St Thomas' Street
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City/town
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London
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Zip/Postcode
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SE1 9RT
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Country
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United Kingdom
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Tel
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+44 (0)20 7188 0502
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Email
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yakoub.khalaf@kcl.ac.uk
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Sponsor
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Record Provided by the NHSTCT Register - 2005 Update - Department of Health (UK)
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Address
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The Department of Health
Richmond House
79 Whitehall
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City/town
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London
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Zip/Postcode
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SW1A 2NL
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Country
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United Kingdom
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Tel
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+44 (0)20 7307 2622
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Fax
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+44 (0)20 7307 2623
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Email
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dhmail@doh.gsi.org.uk
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Sponsor website:
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http://www.dh.gov.uk/Home/fs/en
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Date applied
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30/09/2005
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Last edited
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01/07/2010
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Date ISRCTN assigned
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30/09/2005
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