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.
| ISRCTN | ISRCTN71286562 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN71286562 |
| Protocol serial number | N0013146096 |
| Sponsor | Department of Health |
| Funder | Guy's and St. Thomas' NHS Foundation Trust (UK) - NHS R&D Support Funding |
- Submission date
- 30/09/2005
- Registration date
- 30/09/2005
- Last edited
- 01/07/2010
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Pregnancy and Childbirth
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Yakoub A Khalaf
Scientific
Scientific
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
| Phone | +44 (0)20 7188 0502 |
|---|---|
| yakoub.khalaf@kcl.ac.uk |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| Scientific title | |
| Study objectives | 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(s) | Added 25/06/10: Received from South East London REC 1 (formerly Guy's Research Ethics Committee) |
| Health condition(s) or problem(s) studied | Embryo implantation |
| Intervention | Randomised controlled trial of patients into antibiotics or no treatment. |
| Intervention type | Other |
| Primary outcome measure(s) |
Incidence of bacterial contamination of mock catheter and embryo transfer catheter, embryo implantation and pregnancy rates. |
| Key secondary outcome measure(s) |
Not provided at time of registration |
| Completion date | 01/05/2004 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Female |
| Target sample size at registration | 350 |
| Key inclusion criteria | Patients undergoing embryo transfer without any indication of pelvic infection. |
| Key exclusion criteria | 1. Patients allergic to penicillin 2. Patients previously in trial 3. Patients who required antibiotics at the time of egg collection |
| Date of first enrolment | 01/03/2004 |
| Date of final enrolment | 01/05/2004 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
Guy's & St Thomas' NHS Foundation Trust
London
SE1 9RT
United Kingdom
SE1 9RT
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/11/2006 | Yes | No |
