Plain English Summary
Background and study aims
About 1 in 7 couples have difficulty conceiving and infertility is recognised to be one of the most life-changing events in healthy young adults. In most cases, IVF is the only option that will improve their chance of a family. Routine IVF treatment involves collecting eggs by inserting a needle through the vagina into the follicles in the ovary. Each follicle contains an egg. The eggs are then taken to the laboratory to be mixed with sperm to create an embryo. The embryo is then transferred to the womb about 3-5 days later. During this procedure eggs and embryos are outside the protective environment of the body and are susceptible to environmental stress. There is a lot of evidence to show that the stage of development of eggs at this time is extremely sensitive to temperature and pH (acidity) changes and that controlled temperature and pH are necessary for successful fertilization. “Eggcell” is a medical device which has been developed to allow collection of eggs into an enclosed, warm environment. This protects the eggs from the environmental variations that occur in the standard test tube procedures. Eggcell use may improve the chance of eggs developing normally. The aim of this study is to compare egg recovery rates using Eggcell compared to standard techniques.
Who can participate?
Women aged 23-39 who are undergoing routine IVF treatment.
What does the study involve?
Participants are randomly allocated to one of two groups. Those in the first group have their eggs collected using the standard test tube method. Those in the second group have their eggs collected using the Eggcell method. The clinical procedure for the patient is unchanged. The egg collection procedure will be explained to the patient (orally and in writing) prior to starting treatment according to routine clinical practice in both groups. Information is collected from the patients’ medical notes about medical and fertility history and to record the outcome of the fertility treatment. There are no follow up visits or assessments required and information about how many participants in each group become pregnant and have a baby is assessed by reviewing medical records.
What are the possible benefits and risks of participating?
There are no direct benefits or risks involved with participating in this study.
Where is the study run from?
Freeman Hospital (UK)
When is the study starting and how long is it expected to run for?
April 2016 to December 2018
Who is funding the study?
National Institute for Health Research (UK)
Who is the main contact?
Ms Sarah Dunn
Ms Sarah Dunn
Newcastle Clinical Trials Unit
1-4 Claremont Terrace
Newcastle upon Tyne
+44 191 208 2521
A trial of egg recovery rates for IVF using a collection chamber that provides environmental control: Eggcell Trial
The aim of this study is to compare the recovery rate of eggs aspirated from the ovary using Eggcell (a medical device that enables collection of the fluid into an enclosed, warm environment) with the current test tube method.
North East - Newcastle & North Tyneside 2 Research Ethics Committee, 31/10/2016, ref: 16.NE.0330
Randomised; Interventional; Design type: Process of Care, Device
Primary study design
Secondary study design
Randomised parallel trial
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Specialty: Reproductive health and childbirth, Primary sub-specialty: Reproductive and Sexual Medicine; UKCRC code/ Disease: Reproductive Health and Childbirth/ Other obstetric conditions, not elsewhere classified
Participants will be randomised in the ratio 1:1 to receive either Eggcell or standard treatment using permuted random blocks of variable length. Randomisation will be stratified by site. An individual not otherwise involved with the study will produce the final randomisation schedule for use by this system.
Control group: Participants undergo egg collection using standard techniques. This involves a standard practice of ultrasound guided transvaginal egg collection carried out across the UK.
Intervention group: Participants undergo egg collection using the Eggcell procedure. The clinical procedure for the patient is unchanged for the routine planned procedure. The egg collection procedure will have been explained to the patient (orally and in writing) prior to starting treatment according to routine clinical practice. She will have signed the required treatment and HFEA consent forms.
Preparation for the clinical procedure will be carried out according to the clinic policy for ultrasound guided transvaginal egg collection. When the patient is positioned for egg collection, the “Flush’ foot pedal is depressed to pass warm fluid through the collection needle. This will ensure that the needle is warm before the procedure starts.
After insertion of the needle into the ovarian follicle, the ‘Collection’ foot pedal is depressed to aspirate the follicular fluid. When the follicle is fully collapsed according to the ultrasound appearance, the next follicle is treated. The egg collection procedure is completed according to routine practice.
There will be no follow up visits or assessments required from the patient that are related to participation in the Trial. For the collection of follow up data required for the Trial, this will be obtained by a review of their clinical records.
Primary outcome measures
Egg recovery rate per patient defined as the number of eggs recovered divided by the number of follicles aspirated is assessed on the egg collection day.
Secondary outcome measures
1. Fertilisation rate defined as the total number of fertilised eggs with 2PN seen on day 1divided by the total number of MII eggs retrieved on the egg collection day (day 1)
2. The number of TOP grade embryos on days 3 (cleavage stage) and 5 (blastocyst). Embryo development will be graded according to the United Kingdom National External Quality Assessment Service (UK NEQAS) grading system - Embryo Morphology Scheme .
3. Early treatment outcome defined as the presence of an intrauterine sac containing at least one foetal pulse per egg collection on day 14/+21 days
4. Implantation rate defined as the total number of foetal pulsations divided by the total number of embryos transferred on day 14/+21 days
5. Live birth rate defined as the total number of babies born divided by the total number of egg collections at 9 months/+3 months
6. Delivery rate per embryo defined as the total number live birth events divided by the total number of embryos transferred at 9 months/+3 months
7. Clinician’s experience of each procedure recorded using a questionnaire designed for the purpose of this study on the egg collection day
8. Embryologist’s experience of each procedure recorded using a questionnaire designed for the purpose of this study on the egg collection day
Overall trial start date
Overall trial end date
Participant inclusion criteria
1. Women having routine IVF treatment can be considered who have grown ≥10 and ≤20 follicles of size >/= 16mm in diameter as seen on the scan prior to hCG injection.
2. Provision of informed consent
3. Aged 23-39 (inclusive)
Target number of participants
Planned Sample Size: 724; UK Sample Size: 724
Participant exclusion criteria
1. Women who have grown less than 10 or more than 20 follicles of size 16mm in diameter
2. Unable to give informed consent
3. Insufficient English to allow completion of informed consent and study questionnaire
4. Women with a previous poor recovery rate (<50%)
5. Previous participation in this study
6. Women who have indicated that they do not wish to be involved in research
Recruitment start date
Recruitment end date
Countries of recruitment
Trial participating centre
Freeman Road High Heaton
Newcastle upon Tyne
Newcastle upon Tyne Hospitals NHS Foundation Trust
+44 191 2825789
National Institute for Health Research
Funding Body Type
Funding Body Subtype
Results and Publications
Publication and dissemination plan
1. Progress and final outcomes will be disseminated at relevant conferences by platform and poster presentations
2. The findings will be submitted for publication in peer reviewed journals. Results will also be reported to the Sponsor and Funder, and will be available on their websites. Manuscripts, abstracts and other modes of presentation will be reviewed by the Trial Steering Committee and Funder prior to submission. Individual patients will not be identifiable in any study report.
3. Planned feedback to centres via newsletters, trial close down meetings and publications. Feedback in the form of a lay summary will be provided to participants via a participant-specific newsletter at the end of trial (if they indicated they wished to receive it) and by wider publicity generated.
IPD Sharing plan:
The datasets generated during and/or analysed during the current study is not expected to be made available due to the strict confidentiality regulations of the HFEA and that specific combinations of clinical data could identify individuals.
Intention to publish date
Participant level data
Not expected to be available
Results - basic reporting
- ISRCTN15509950_PIS_05Jan17_V2.docx Uploaded 27/02/2017