Condition category
Pregnancy and Childbirth
Date applied
30/09/2005
Date assigned
30/09/2005
Last edited
01/07/2010
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Yakoub A Khalaf

ORCID ID

Contact details

Guy's & St Thomas' NHS Foundation Trust
Assisted Conception Unit
4th Floor
Thomas' Guy House
Guy's Hospital
St Thomas' Street
London
SE1 9RT
United Kingdom
+44 (0)20 7188 0502
yakoub.khalaf@kcl.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N0013146096

Study information

Scientific title

Acronym

Study hypothesis

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.

Ethics approval

Added 25/06/10:
Received from South East London REC 1 (formerly Guy's Research Ethics Committee)

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Prevention

Patient information sheet

Condition

Embryo implantation

Intervention

Randomised controlled trial of patients into antibiotics or no treatment.

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

Incidence of bacterial contamination of mock catheter and embryo transfer catheter, embryo implantation and pregnancy rates.

Secondary outcome measures

Not provided at time of registration

Overall trial start date

01/03/2004

Overall trial end date

01/05/2004

Reason abandoned

Eligibility

Participant inclusion criteria

Patients undergoing embryo transfer without any indication of pelvic infection.

Participant type

Patient

Age group

Adult

Gender

Female

Target number of participants

350

Participant exclusion criteria

1. Patients allergic to penicillin
2. Patients previously in trial
3. Patients who required antibiotics at the time of egg collection

Recruitment start date

01/03/2004

Recruitment end date

01/05/2004

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Guy's & St Thomas' NHS Foundation Trust
London
SE1 9RT
United Kingdom

Sponsor information

Organisation

Department of Health

Sponsor details

Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
+44 (0)20 7307 2622
dhmail@doh.gsi.org.uk

Sponsor type

Government

Website

http://www.dh.gov.uk/Home/fs/en

Funders

Funder type

Government

Funder name

Guy's and St. Thomas' NHS Foundation Trust (UK) - NHS R&D Support Funding

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

2006 results in http://www.ncbi.nlm.nih.gov/pubmed/16832124

Publication citations

  1. Results

    Brook N, Khalaf Y, Coomarasamy A, Edgeworth J, Braude P, A randomized controlled trial of prophylactic antibiotics (co-amoxiclav) prior to embryo transfer., Hum. Reprod., 2006, 21, 11, 2911-2915, doi: 10.1093/humrep/del263.

Additional files

Editorial Notes