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

ISRCTN ISRCTN57835722
DOI https://doi.org/10.1186/ISRCTN57835722
Protocol serial number N0084096582
Sponsor Department of Health
Funder The North and South Bank Research and Development Consortium (UK)
Submission date
30/09/2004
Registration date
30/09/2004
Last edited
31/03/2020
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Pregnancy and Childbirth
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Frank Biervliet
Scientific

Academic Department of Obstetrics & Gynaecology
Hull & East Yorkshire (NHS) Trust
The Princess Royal Hospital
Salthouse Road
Hull
HU8 9HE
United Kingdom

Phone +44 (0)1482 701151
Email abc@email.com

Study information

Primary study designInterventional
Study designRandomised double-blind study
Secondary study designRandomised controlled trial
Scientific titleThe effect of pharmacological agents on uterine junctional zone contractions during mock embryo transfer: a randomised double-blind study
Study objectivesTo assess if junctional zone contractions can be reduced by pharmacological agents.
Ethics approval(s)Not provided at time of registration
Health condition(s) or problem(s) studiedPregnancy and Childbirth: Embryo transfer
InterventionThe 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 typeDrug
PhaseNot Applicable
Drug / device / biological / vaccine name(s)
Primary outcome measure(s)

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

Key secondary outcome measure(s)

Not provided at time of registration

Completion date10/12/2003

Eligibility

Participant type(s)Patient
Age groupAdult
SexFemale
Target sample size at registration80
Key inclusion criteriaNot provided at time of registration
Key exclusion criteriaNot provided at time of registration
Date of first enrolment01/04/2000
Date of final enrolment10/12/2003

Locations

Countries of recruitment

  • United Kingdom
  • England

Study participating centre

The Princess Royal Hospital
Hull
HU8 9HE
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
IPD sharing plan

Editorial Notes

31/03/2020: No publications found, all search options exhausted, study status unverified.