Condition category
Pregnancy and Childbirth
Date applied
12/09/2003
Date assigned
12/09/2003
Last edited
27/08/2010
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 Hany Lashen

ORCID ID

Contact details

University of Sheffield
OGN & Midwifery
4/9
Jessop Wing
Sheffield
S10 2SF
United Kingdom
+44 0114 226 8397
hany.lashen@sth.nhs.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N0059115928

Study information

Scientific title

Acronym

Study hypothesis

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

Not provided at time of registration

Study design

Prospective single centre randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Condition

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

Phase

Not Specified

Drug names

Primary outcome measures

Pregnancy rates.

Secondary outcome measures

Not provided at time of registration

Overall trial start date

01/10/2002

Overall trial end date

01/10/2003

Reason abandoned

Eligibility

Participant inclusion criteria

IVF patients

Participant type

Patient

Age group

Adult

Gender

Female

Target number of participants

150

Participant 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

Recruitment start date

01/10/2002

Recruitment end date

01/10/2003

Locations

Countries of recruitment

United Kingdom

Trial participating centre

University of Sheffield
Sheffield
S10 2SF
United Kingdom

Sponsor information

Organisation

Department of Health (UK)

Sponsor details

Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom

Sponsor type

Government

Website

http://www.doh.gov.uk

Funders

Funder type

Hospital/treatment centre

Funder name

Sheffield Teaching Hospitals (Central Campus)

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

2005 results in http://www.ncbi.nlm.nih.gov/pubmed/16213855

Publication citations

  1. Results

    McIlveen M, Lok FD, Pritchard J, Lashen H, Modern embryo transfer catheters and pregnancy outcome: a prospective randomized trial., Fertil. Steril., 2005, 84, 4, 996-1000, doi: 10.1016/j.fertnstert.2005.06.018.

Additional files

Editorial Notes