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 |
| Secondary identifying numbers | N0084096582 |
- 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
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 |
|---|---|
| abc@email.com |
Study information
| Study design | Randomised double-blind study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Scientific title | The effect of pharmacological agents on uterine junctional zone contractions during mock embryo transfer: a randomised double-blind study |
| Study objectives | To 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) studied | 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 |
| Pharmaceutical study type(s) | |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | |
| Primary outcome measure | 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 study start date | 01/04/2000 |
| Completion date | 10/12/2003 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Female |
| Target number of participants | 80 |
| Key inclusion criteria | Not provided at time of registration |
| Key exclusion criteria | Not provided at time of registration |
| Date of first enrolment | 01/04/2000 |
| Date of final enrolment | 10/12/2003 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
The Princess Royal Hospital
Hull
HU8 9HE
United Kingdom
HU8 9HE
United Kingdom
Sponsor information
Department of Health
Government
Government
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
| Website | http://www.dh.gov.uk/Home/fs/en |
|---|
Funders
Funder type
Research organisation
The North and South Bank Research and Development Consortium (UK)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Editorial Notes
31/03/2020: No publications found, all search options exhausted, study status unverified.
