A trial of egg recovery rates for IVF using a collection chamber that provides environmental control: Eggcell Trial
| ISRCTN | ISRCTN15509950 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN15509950 |
| Secondary identifying numbers | 32163, Eudamed Number: CIV-GB-17-10-021745 |
- Submission date
- 15/12/2016
- Registration date
- 27/02/2017
- Last edited
- 15/12/2022
- Recruitment status
- Suspended
- Overall study status
- Suspended
- Condition category
- Pregnancy and Childbirth
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?
Newcastle Fertility Centre (UK)
When is the study starting and how long is it expected to run for?
February 2019 to November 2020 (updated 16/10/2020, previously: December 2020)
Who is funding the study?
National Institute for Health Research (UK)
Who is the main contact?
Dr Karen Nicholson
Karen.Nicholson2@newcastle.ac.uk
Contact information
Public
Newcastle Clinical Trials Unit
1-4 Claremont Terrace
Newcastle University
Newcastle upon Tyne
NE2 4AE
United Kingdom
| Phone | +44 191 208 2521 |
|---|---|
| Karen.Nicholson2@newcastle.ac.uk |
Public
Newcastle Clinical Trials Unit
1–4 Claremont Terrace
Newcastle University
Newcastle upon Tyne
NE2 4AE
United Kingdom
| Phone | +44 (0) 191 2083819 |
|---|---|
| Chrissie.Butcher@ncl.ac.uk |
Scientific
Biomedicine West Wing
International Centre for Life
Times Square
Newcastle upon Tyne
NE1 4EP
United Kingdom
| alison.murdoch@newcastle.ac.uk |
Study information
| Study design | Randomised; Interventional; Design type: Process of Care, Device |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised parallel trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | ISRCTN15509950_PIS_05Jan17_V2.docx |
| Scientific title | A trial of egg recovery rates for IVF using a collection chamber that provides environmental control: Eggcell Trial |
| Study acronym | Eggcell |
| Study hypothesis | 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. |
| Ethics approval(s) | Approved 31/10/2016, North East - Newcastle & North Tyneside 2 Research Ethics Committee, ref: 16.NE.0330 |
| Condition | 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 |
| Intervention | 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. |
| Intervention type | Other |
| Primary outcome measure | 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 study start date | 29/04/2016 |
| Overall study end date | 30/11/2020 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Female |
| Target number of participants | Planned Sample Size: 749; UK Sample Size: 749 |
| 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) |
| 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 | 01/02/2019 |
| Recruitment end date | 19/10/2020 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
International Centre for Life
Times Square
Newcastle upon Tyne
NE1 4EP
United Kingdom
Sponsor information
Hospital/treatment centre
Regulatory Compliance Manager
Newcastle Joint Research Office
The Newcastle upon Tyne Hospitals NHS Foundation Trust
Level 1, Regent Point
Regent Farm Road
Gosforth
Newcastle-upon-Tyne
NE3 3HD
England
United Kingdom
| Phone | +44 191 2825789 |
|---|---|
| Aaron.Jackson@nuth.nhs.uk | |
| Website | https://newcastlejro.com/ |
"ROR" |
https://ror.org/05p40t847 |
Funders
Funder type
Government
Government organisation / National government
- Alternative name(s)
- National Institute for Health Research, NIHR Research, NIHRresearch, NIHR - National Institute for Health Research, NIHR (The National Institute for Health and Care Research), NIHR
- Location
- United Kingdom
Results and Publications
| Intention to publish date | 31/12/2020 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not expected to be made available |
| 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. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | version V2 | 05/01/2017 | 27/02/2017 | No | Yes |
| Participant information sheet | version V3.0 | 28/10/2018 | 02/03/2020 | No | Yes |
| Other publications | Eggcell laboratory validation prior to use with human participants | 15/12/2022 | 15/12/2022 | Yes | No |
Additional files
- ISRCTN15509950_PIS_05Jan17_V2.docx
- Uploaded 27/02/2017
- ISRCTN15509950_PIS_V3.0_28Oct2018.pdf
- Uploaded 02/03/2020
Editorial Notes
15/12/2022: The publication does not report the trial as originally planned because delays in regulation and COVID resulted in the loss of some funding. The full trial is therefore paused pending further funding but the results of the safety data have been published.
15/12/2022: Publication reference added.
12/07/2022: Internal review.
01/07/2021: The trial contact has been updated.
15/06/2021: Due to current public health guidance, this study has been paused.
16/10/2020: The following changes were made to the trial record:
1. The recruitment end date was changed from 31/10/2020 to 19/10/2020.
2. The overall end date was changed from 31/12/2020 to 30/11/2020.
3. The plain English summary was updated to reflect these changes.
11/08/2020: The following changes were made to the trial record:
1. Recruitment to this study is no longer paused.
2. The recruitment end date was changed from 30/04/2020 to 31/10/2020.
3. The overall trial end date was changed from 31/07/2020 to 31/12/2020.
4. The intention to publish date was changed from 31/07/2020 to 31/12/2020.
20/04/2020: Due to current public health guidance, recruitment for this study has been paused as of 19/03/2020.
02/03/2020: The trial received MHRA no objection notice as of 22/10/2018. The following changes have been made:
1. The recruitment start date has been changed from 01/07/2017 to 01/02/2019.
2. The recruitment end date has been changed from 01/02/2018 to 30/04/2020.
3. The overall trial end date has been changed from 31/12/2018 to 31/07/2020.
4. The intention to publish date has been changed from 31/12/2018 to 31/07/2020.
5. The target number of participants has been changed from "Planned Sample Size: 724; UK Sample Size: 724" to "Planned Sample Size: 749; UK Sample Size: 749".
6. The total target enrolment has been changed from 724 to 749.
7. The trial participating centre has been changed from "Freeman Hospital" to "Newcastle Fertility Centre".
8. The participant information sheet has been added.
9. The sponsor details have been updated.
10. A public contact has been added.
11. A scientific contact has been added.
12. The plain English summary has been updated to reflect the changes above.
13/04/2018: This trial has been put on hold following a notice of objection from the MHRA. The Chief Investigator is currently appealing the MHRA assessors decision. The trial did not begin recruitment as planned and is still yet to open.
10/05/2017: The recruitment start date has been updated from 01/05/2017 to 01/07/2017
