Reproductive Health and Childbirth
Eggclee - Closedown/Analysis
A trial of egg recovery rates for IVF using a collection chamber that provides environmental control
- Study stage: Closedown/Analysis
- Sponsor: The Newcastle upon Tyne Hospitals NHS Foundation Trust
- Funder: NIHR i4i
- Therapeutic area: Reproductive Health and Childbirth (IVF)
- Type of study: Clinical Investigation (non CE Marked device)
Aim: To obtain safety data about Eggcell in clinical practice. To confirm that eggs can be recovered in Eggcell and that these eggs can fertilise and the embryos can develop to blastocysts. We will confirm the user acceptance of, and proficiency with revised pump technology before commencing the randomised trial to compare the egg recovery rate of Eggcell with existing technology.
Primary outcome:
Comparison of egg recovery rate between the new device (Eggcell) and standard technology.
- Population: Adult
- Phase: I
- Design: RCT
- Setting: Tertiary care
- Planned Sample Size: 749
Empower - Closed
EMesis in Pregnancy - Ondansetron With mEtoclopRamide
- Study stage: Closed
- Sponsor: The Newcastle upon Tyne Hospitals NHS Foundation Trust
- Funder: NIHR HTA
- Therapeutic area: Reproductive Health and Childbirth
- Type of study: CTIMP
Aim: To determine whether, in addition to IV rehydration, ondansetron vs placebo ondansetron and metoclopramide vs placebo metoclopramide reduce the rate of treatment failure up to 10 days after initiation.
Primary outcome:
The number of participants requiring high dose ondansetron or corticosteroids between 12 hours and 10 days post first dose of IMP treatment
- Population: Adult
- Phase: III
- Design: RCT(with internal pilot) Qualitative and Health Economics
- Setting: Secondary Care
- Planned Sample Size: 59
FACT - Closed
Effect of folic acid supplementation in pregnancy preeclampsia
- Study stage: Closed
- UK Sponsor: The Newcastle upon Tyne Hospitals NHS Foundation Trust
- Funder: Canadian Institute of Health Research (CIHR)
- Therapeutic area: Reproductive Health and Childbirth (IVF)
- Type of study: CTIMP
Aim: The overall aim of this randomized controlled trial is to evaluate a new preeclampsia (PE) prevention strategy of high dose folic acid supplementation from early (80/7 to 166/7weeks of gestation) pregnancy until delivery.
Primary Outcome:
Preeclampsia (PE) is the primary outcome measure.
PE is defined as blood pressure ≥d90 mmHg on two occasions ≥4 hours apart and proteinuria developed in women greater than 20 weeks of gestation.
- Population: Adult
- Phase: III
- Design: RCT
- Setting: Secondary Care
- Planned Sample Size: 3064