E-Freeze: Freezing of embryos in assisted conception
| ISRCTN | ISRCTN61225414 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN61225414 |
| Secondary identifying numbers | N/A |
- Submission date
- 24/12/2015
- Registration date
- 29/12/2015
- Last edited
- 29/07/2024
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Pregnancy and Childbirth
Plain English Summary
Current plain English summary as of 07/05/2019:
Background and study aims
In order for a woman to become pregnant, the fertilised egg must attach (implant) itself to the lining of the womb. In vitro fertilisation (IVF) is a technique used to help people with fertility problems to have a baby. During IVF, couples donate their own sperm and eggs (or use sperm and eggs from a donor). The egg is fertilised by the sperm outside of the body to create an embryo and then returned to the woman’s womb to develop, approximately three days later (fresh embryo transfer). Although IVF has become more and more successful in recent years, there is still a relatively high failure rate. In many cases, some of the embryos are frozen so that they can be thawed out and used in IVF at a later date (frozen embryo transfer). The aim of this study is to find out the effectiveness and cost-effectiveness of using frozen embryo transfer three months after egg donation, compared to fresh embryo transfer, and whether the technique used has an effect of the health of the baby at birth.
Who can participate?
Couples undergoing their first, second or third round of IVF fertility treatment at fertility centres in the UK.
What does the study involve?
Couples are randomly allocated to one of two groups. At the start of the study, all participants donate sperm and eggs so that embryos can be created. For participants in the first group, three days after egg donation, the fertilised embryos are placed in the female participants’ womb. For participants in the second group, the fertilised embryos are frozen, for later use. These embryos are then thawed three months after the egg donation and implanted into the female participants’ womb. Women in both groups are monitored to find out how many become pregnant. For those who do, the health of the baby is assessed by the medical team at the time of birth.
What are the possible benefits and risks of participating?
There are no immediate direct benefits of taking part in the study, but participating will help to inform future fertility treatment in the UK. There are no additional risks to the standard risks involved with IVF.
Where is the study run from?
Twelve fertility units in the Scotland and England (UK).
When is the study starting and how long is it expected to run for?
March 2015 to January 2021 (updated 08/07/2020, previously: June 2020)
Who is funding the study?
National Institute for Health Research (UK)
Who is the main contact?
1. Ms Christina Cole (public), christina.cole@npeu.ox.ac.uk
(updated 08/07/2020, previously: Ms Fiona Goodgame (public), fiona.goodgame@npeu.ox.ac.uk)
2. Dr Abha Maheshwari (scientific), a.maheshwari@abdn.ac.uk
Previous plain English summary:
Background and study aims
In order for a woman to become pregnant, the fertilised egg must attach (implant) itself to the lining of the womb. In vitro fertilisation (IVF) is a technique used to help people with fertility problems to have a baby. During IVF, couples donate their own sperm and eggs (or use sperm and eggs from a donor). The egg is fertilised by the sperm outside of the body to create an embryo and then returned to the woman’s womb to develop, approximately three days later (fresh embryo transfer). Although IVF has become more and more successful in recent years, there is still a relatively high failure rate. In many cases, some of the embryos are frozen so that they can be thawed out and used in IVF at a later date (frozen embryo transfer). The aim of this study is to find out the effectiveness and cost-effectiveness of using frozen embryo transfer three months after egg donation, compared to fresh embryo transfer, and whether the technique used has an effect of the health of the baby at birth.
Who can participate?
Couples undergoing their first, second or third round of IVF fertility treatment at fertility centres in the UK.
What does the study involve?
Couples are randomly allocated to one of two groups. At the start of the study, all participants donate sperm and eggs so that embryos can be created. For participants in the first group, three days after egg donation, the fertilised embryos are placed in the female participants’ womb. For participants in the second group, the fertilised embryos are frozen, for later use. These embryos are then thawed three months after the egg donation and implanted into the female participants’ womb. Women in both groups are monitored to find out how many become pregnant. For those who do, the health of the baby is assessed by the medical team at the time of birth.
What are the possible benefits and risks of participating?
There are no immediate direct benefits of taking part in the study, but participating will help to inform future fertility treatment in the UK. There are no additional risks to the standard risks involved with IVF.
Where is the study run from?
Twelve fertility units in the Scotland and England (UK).
When is the study starting and how long is it expected to run for?
March 2015 to June 2020
Who is funding the study?
National Institute for Health Research (UK)
Who is the main contact?
1. Ms Christina Cole (public)
christina.cole@npeu.ox.ac.uk
2. Dr Abha Maheshwari (scientific)
abha.maheshwari@abdn.ac.uk
Contact information
Public
NPEU
Nuffield Department of Population Health
University of Oxford
Old Road Campus
Oxford
OX3 7LF
United Kingdom
| christina.cole@npeu.ox.ac.uk |
Scientific
Aberdeen Maternity Hospital
Foresterhill
Aberdeen
AB25 2ZL
United Kingdom
Study information
| Study design | Pragmatic multi-centre parallel-group randomized controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Other |
| Scientific title | Freezing of embryos in assisted conception: a randomised controlled trial evaluating the clinical and cost-effectiveness of a policy of freezing embryos followed by thawed frozen embryo transfer, compared with a policy of fresh embryo transfer in women undergoing in-vitro fertilization. |
| Study acronym | E-Freeze |
| Study hypothesis | The aim of this study is to determine if a policy of freezing embryos, followed by thawed frozen embryo transfer results in a higher healthy baby rate when compared with the current policy of transferring fresh embryos. |
| Ethics approval(s) | North of Scotland Research Ethics Committee, 12/11/2015, ref: 15/NS/0114 |
| Condition | Infertility |
| Intervention | Couples will be randomly allocated to either the standard care or intervention arm. Standard care arm: Women will undergo fresh embryo transfer on day 3 or 5 (after egg collection). Intervention arm: All good quality embryos will be frozen and couples will undergo frozen thawed embryo transfer within 3 months of the egg collection process. Couples will attend for a clinic visit and additional monitoring visits before frozen embryo transfer is performed. Data be collected using bespoke electronic data collection forms at 6 time points between consent and 6 weeks post delivery. An emotions questionnaire will also be completed both after consent and at embryo transfer to understand how couples are feeling. And an economic questionnaire will be used to understand time and travel expenses accrued during their treatment. |
| Intervention type | Procedure/Surgery |
| Primary outcome measure | Health of the baby is determined by medical staff at the time of birth. |
| Secondary outcome measures | 1. Live birth rate 2. Pregnancy rate (defined as positive pregnancy test - 2 weeks after embryo transfer) 3. Clinical pregnancy rate (a pregnancy diagnosed by ultrasonic visualisation of one or more gestational sacs or definitive clinical signs of pregnancy; ectopic counts as clinical pregnancy; multiple gestational sacs count as one clinical pregnancy) 4. Ongoing pregnancy (pregnancy with presence of foetal heart beat) 5. Ovarian hyperstimulation syndrome (OHSS) 6. Miscarriage rate 7. Gestational diabetes mellitus (GDM) 8. Multiple pregnancy 9. Hypertensive disorders of pregnancy (comprising pregnancy induced hypertension; pre-eclampsia and eclampsia) 10. Antepartum haemorrhage 11. Preterm delivery (defined as delivery at <37 completed weeks) 12. Very preterm delivery (defined as delivery at <32 completed weeks) 13. Low birth weight (defined as weight < 2500 g at birth) 14. Very low birth weight (defined as < 1500 g at birth) 15. Large for gestational age (defined as birth weight >90th centile for gestation, based on standardised charts) 16. Small for gestational age (defined as less than 10th centile for gestational age at delivery) 17. Congenital anomaly (all congenital anomalies identified will be included) 18. Perinatal mortality (late as well as early neonatal deaths, up to 28 days after birth) 19. Evaluation of emotional state 20. Health economic outcome measures: 20.1. Costs to the health service of treatment, pregnancy and delivery care 20.2. Modelled long-term costs of health and social care, and broader societal costs |
| Overall study start date | 01/03/2015 |
| Overall study end date | 31/01/2021 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 1,086 |
| Total final enrolment | 619 |
| Participant inclusion criteria | Current participant inclusion criteria (as of 24/01/2018): 1. The female partner is between 18 and 42 years of age at the start of treatment (i.e. start of ovarian stimulation) 2. Couples who are undergoing their first second or third cycle of IVF/ICSI treatment 3. Both partners are resident in the UK 4. Both partners are able to provide written informed consent Previous participant inclusion criteria 1. The female partner is between 18 and 42 years of age at the start of treatment (i.e. start of ovarian stimulation) 2. Couples who are undergoing their first cycle of IVF/ICSI treatment 3. Both partners are resident in the UK 4. Both partners are able to provide written informed consent |
| Participant exclusion criteria | Couples in whom: 1. Donor gametes are used 2. Pre-implantation genetic diagnosis is performed 3. Elective freezing of all embryos is preferred or clinically indicated (e.g. severe risk of OHSS) |
| Recruitment start date | 01/01/2016 |
| Recruitment end date | 30/04/2019 |
Locations
Countries of recruitment
- England
- Scotland
- United Kingdom
Study participating centres
Foresterhill
Aberdeen
AB25 2ZL
United Kingdom
1st Floor
Oxford Road
Manchester
M13 9WL
United Kingdom
Tree Root Walk
Sheffield
S10 2SF
United Kingdom
London
SE5 9RS
United Kingdom
Coxford Road
Southampton
SO16 5YA
United Kingdom
Liverpool
L8 7SS
United Kingdom
Great Maze Pond
London
SE1 9RT
United Kingdom
Du Cane Road
London
W12 0HS
United Kingdom
Interchange Business Park
Sandiacre
Nottingham
NG10 5QE
United Kingdom
London
E9 6SR
United Kingdom
Oxford Business Park North
Oxford
OX4 2HW
United Kingdom
Birmingham
B15 2TG
United Kingdom
Sponsor information
Hospital/treatment centre
Research & Development
Foresterhill House Annexe
Foresterhill
Aberdeen
AB25 2ZB
Scotland
United Kingdom
| Website | http://www.nhsgrampian.org/nhsgrampian/gra_display_home_2015.jsp?p_applic=CCC&p_service=Content.show&pContentID=9298& |
|---|---|
"ROR" |
https://ror.org/00ma0mg56 |
University/education
Research Governance Office
Foresterhill House Annexe
Foresterhill
Aberdeen
AB25 2ZB
Scotland
United Kingdom
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 | 30/06/2021 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | The research will be submitted for publication in high impact peer-reviewed scientific journals. |
| IPD sharing plan | Applications for data sharing should be made to the NPEU CTU, using ctu@npeu.ox.ac.uk, with an accompanying protocol for the intended use of the data. This will be reviewed by the Trial Steering Committee or Data Controller if the TSC no longer exist. If approved, a Data Sharing Agreement will be compiled laying out the conditions to which the requestor must abide by. A cost may be incurred if the data requires additional work prior to sharing. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol article | 13/06/2019 | 17/06/2019 | Yes | No | |
| Statistical Analysis Plan | 30/06/2020 | 02/07/2020 | No | No | |
| Results article | 06/01/2022 | 10/01/2022 | Yes | No | |
| Funder report results | 01/05/2022 | 24/05/2022 | No | No | |
| HRA research summary | 28/06/2023 | No | No | ||
| Results article | 13/06/2024 | 29/07/2024 | Yes | No |
Editorial Notes
29/07/2024: Publication reference added.
24/05/2022: Publication reference added.
10/01/2022: Publication reference added.
01/09/2021: The study contact has been updated and the plain English summary has been updated accordingly.
08/07/2020: The following changes were made to the trial record:
1. The overall end date was changed from 30/06/2020 to 31/01/2021.
2. The public contact was changed.
3. The plain English summary was updated to reflect these changes.
02/07/2020: Publication reference added.
17/06/2019: Publication reference added.
07/05/2019: The following changes were made:
1. The total final enrolment was added.
2. The public contact was updated.
3. The plain English summary was updated.
24/01/2018: The following changes were made
1. Ethics approval date was added.
2. Recruitment end date was changed from 31/12/2017 to 30/04/2019.
3. Overall trial end date was changed from 28/02/2019 to 30/06/2020.
4. Publication plan, intention to publish date and participant level data were added.
5. Participant inclusion criteria was updated.
