Condition category
Pregnancy and Childbirth
Date applied
30/09/2004
Date assigned
30/09/2004
Last edited
05/12/2014
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 Frank Biervliet

ORCID ID

Contact details

Academic Department of Obstetrics & Gynaecology
Hull & East Yorkshire (NHS) Trust
The Princess Royal Hospital
Salthouse Road
Hull
HU8 9HE
United Kingdom
+44 (0)1482 701151
abc@email.com

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N0084096582

Study information

Scientific title

The effect of pharmacological agents on uterine junctional zone contractions during mock embryo transfer: a randomised double-blind study

Acronym

Study hypothesis

To assess if junctional zone contractions can be reduced by pharmacological agents.

Ethics approval

Not provided at time of registration

Study design

Randomised double-blind study

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Condition

Pregnancy and Childbirth: Embryo transfer

Intervention

The patient's baseline junctional zone contractions will be established following a 5 minute scan. Video tapes taken of both the pre and post mock embryo transfer will be assessed by two researchers who will be unaware of treatment.
20 patients allocated to the nitric oxide group, 20 to the non-steroidal anti-inflammatory group, 20 control and 20 to the COX-2 inhibitor group.

Intervention type

Drug

Phase

Not Applicable

Drug names

Primary outcome measures

1. Number of contractions per unit time
2. Speed of contractions in cm/min
3. Type of contractions
4. Speed of Echovist
5. Distance traveled by Echovist

Secondary outcome measures

Not provided at time of registration

Overall trial start date

01/04/2000

Overall trial end date

10/12/2003

Reason abandoned

Eligibility

Participant inclusion criteria

Not provided at time of registration

Participant type

Patient

Age group

Adult

Gender

Female

Target number of participants

80

Participant exclusion criteria

Not provided at time of registration

Recruitment start date

01/04/2000

Recruitment end date

10/12/2003

Locations

Countries of recruitment

United Kingdom

Trial participating centre

The Princess Royal Hospital
Hull
HU8 9HE
United Kingdom

Sponsor information

Organisation

Department of Health

Sponsor details

Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom

Sponsor type

Government

Website

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

Funders

Funder type

Research organisation

Funder name

The North and South Bank Research and Development Consortium (UK)

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

Publication citations

Additional files

Editorial Notes