A prospective randomised trial comparing two embryo transfer catheters
| ISRCTN | ISRCTN98245481 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN98245481 |
| Protocol serial number | N0059115928 |
| Sponsor | Department of Health (UK) |
| Funder | Sheffield Teaching Hospitals (Central Campus) |
- Submission date
- 12/09/2003
- Registration date
- 12/09/2003
- Last edited
- 27/08/2010
- 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 Hany Lashen
Scientific
Scientific
University of Sheffield
OGN & Midwifery
4/9
Jessop Wing
Sheffield
S10 2SF
United Kingdom
| Phone | +44 0114 226 8397 |
|---|---|
| hany.lashen@sth.nhs.uk |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Prospective single centre randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| Scientific title | |
| Study objectives | To compare the ease of use and pregnancy rates of In-Vitro Fertilisation (IVF) cycles by using Wallace and Cook's embryo transfer catheters for embryo transfer. |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | In vitro fertilisation (IVF) |
| Intervention | Added 27/08/10: Women undergoing a fresh ET were randomized at the time of ET to either the Cook K-Jet or Wallace embryo transfer catheter. The randomization was stratified according to age and the number of previous ETs. |
| Intervention type | Other |
| Primary outcome measure(s) |
Pregnancy rates. |
| Key secondary outcome measure(s) |
Not provided at time of registration |
| Completion date | 01/10/2003 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Female |
| Target sample size at registration | 150 |
| Key inclusion criteria | IVF patients |
| Key exclusion criteria | Added 27/08/10: 1. Age more than 40 years 2. High basal Follicle Stimulating Hormone (FSH) 3. A previous difficult ET or more than six previous ETs |
| Date of first enrolment | 01/10/2002 |
| Date of final enrolment | 01/10/2003 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
University of Sheffield
Sheffield
S10 2SF
United Kingdom
S10 2SF
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 | 01/10/2005 | Yes | No |
