Endometrial scratch trial
| ISRCTN | ISRCTN23800982 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN23800982 |
| Secondary identifying numbers | 30491 |
- Submission date
- 31/05/2016
- Registration date
- 31/05/2016
- Last edited
- 08/02/2022
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Pregnancy and Childbirth
Plain English Summary
Background and study aims
In order for a woman to become pregnant, the fertilized egg must attach (implant) itself to the lining of the womb. In vitro fertilization (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 fertilized by the sperm outside of the body to create an embryo and then returned to the woman’s womb to develop. Although IVF has become more and more successful in recent years, there is still a relatively high failure rate. Taking a small amount of tissue from the lining of the womb (endometrium) can sometimes improve the chance of achieving a pregnancy in women who have previously had several unsuccessful attempts at In Vitro Fertilisation (IVF). This procedure has been named “endometrial scratch” (ES). It is not known exactly why performing an Endometrial Scratch may be beneficial, but it is thought that the process of “scratching” the lining of the womb may release certain chemicals that are important in helping the fertilised egg (embryo) stick to the lining of the womb (implantation). The use of Endometrial Scratch has not yet been fully tried in women who are about to have IVF for the first time. If found to be beneficial then it could be used to improve the chance of achieving a pregnancy for a large group of women without the need for repeated IVF attempts. The aim of this study is to investigate the effectiveness of performing an Endometrial Scratch in younger women (37 years of age or younger) about to start their first IVF treatment cycle.
Who can participate?
Healthy women aged between 18 and 37 who are having their first cycle of IVF.
What does the study involve?
Participants are randomly allocated to one of two groups. Participants in the first group undergo their IVF treatment in the usual way. Participants in the second group also undergo standard IVF, but attend an additional outpatient appointment in which the endometrial scratch is performed (around one week before their IVF treatment starts). Women are advised to take some simple painkillers beforehand (such as paracetamol) as these should lessen the chance of any discomfort as the procedure can sometimes cause period like cramps. The procedure involves placing a small tube (about the size of a small drinking straw) through the neck of the womb and then the lining of the uterus (the endometrium) is gently ‘scratched’. Participants in both groups are followed up for around 10.5 months to see whether or not they get pregnant and have a healthy baby.
What are the possible benefits and risks of participating?
There are no known direct benefits of participating, although the endometrial scratch procedure could help increase the amount of live births. Performing the Endometrial Scratch has no clear risks although, in theory, inserting any instrument into the womb could carry a risk of infection. However all women having IVF are routinely screened for important vaginal infections before starting their IVF treatment.
Where is the study run from?
University of Sheffield Clinical Trials Research Unit (UK)
When is the study starting and how long is it expected to run for?
July 2016 to December 2018
Who is funding the study?
National Institute for Health Research (UK)
Who is the main contact?
Mr Robin Chatters
r.chatters@sheffield.ac.uk
Contact information
Public
Clinical Trials Research Unit
ScHARR
University of Sheffield
Regent Court, 30 Regent Street
Sheffield
S1 4DA
United Kingdom
Study information
| Study design | Randomised; Interventional; Design type: Treatment, Surgery |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | A multicentre randomised controlled trial of induced endometrial scratch in women undergoing first time in vitro fertilisation (IVF) |
| Study hypothesis | The aim of this study is to examine the effect of an Endometrial Scratch (ES) performed in the midluteal phase prior to a first time IVF/ICSI cycle, on the chances of achieving a clinical pregnancy and live birth. |
| Ethics approval(s) | South Central Berkshire Research Ethics Committee, 23/03/2016, ref: 16/SC/0151 |
| Condition | Specialty: Reproductive health and childbirth, Primary sub-specialty: Reproductive and sexual medicine; UKCRC code/ Disease: Reproduction/ Other obstetric conditions, not elsewhere classified |
| Intervention | Women will be randomised to either the intervention or control arm using an online system at a ratio of 1:1 using stratified block randomisation with variable blinded block sizes. Intervention participants will receive the endometrial scratch intervention (i.e. endometrial trauma) in the midluteal phase of their menstrual cycle, during the menstrual cycle preceding that in which they are due to have their IVF/ICSI treatment. Both arms will receive usual IVF/ICSI therapy. Women randomised to the control arm will not receive any intervention above normal care. |
| Intervention type | Other |
| Primary outcome measure | Live birth rate (LBR) after completed 24 weeks gestation is determined by telephone contact with the participant 10.5 months post egg collection. |
| Secondary outcome measures | 1. Acceptability of the Endometrial Scratch procedure is determined by telephone contact with the participant directly after, 24 hours and 7 days post procedure 2. Implantation rate based on a positive serum Beta hCG approximately day 14 post egg collection 3. Clinical pregnancy rate is measured at/after 8 weeks gestation 4. Miscarriage rate is measured 3 and 6 month post egg collection 5. Ectopic pregnancy rate is measured at/after 8 weeks gestation 6. Multiple birth rate is measured 10.5 months post egg collection 7. Preterm delivery rate is measured 6 and 10.5 months post egg collection 8. Still birth rate is measured 6 and 10.5 months post egg collection 9. Adverse events are measured post intervention, 2 weeks, 3- 6- and 10.5 months post egg collection 10. Resource use is measured at baseline, 3 and 10.5 months post egg collection 11. Patient costs are measured 3 months post egg collection |
| Overall study start date | 01/12/2016 |
| Overall study end date | 30/09/2020 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Female |
| Target number of participants | Planned Sample Size: 1044; UK Sample Size: 1044 |
| Total final enrolment | 1048 |
| Participant inclusion criteria | 1. Women aged ≥ 18 and ≤ 37 years of age at time of oocyte removal 2. Women expected to receive IVF with or without ICSI treatment using the antagonist or long protocol only 3. First time IVF with or without ICSI treatment 4. Ovulatory menstrual cycle. (Regular menstrual cycles with ovulatory levels of midluteal serum progesterone as defined by local laboratory protocols) 5. Normal uterine cavity assessed by transvaginal sonography at screening and no endometrial abnormalities such as , polyps, suspected intrauterine adhesions, uterine septa, submucosal fibroids or intramural fibroids exceeding 4 cm in diameter as assessed by the investigator that would require treatment to facilitate pregnancy 6. Local procedures have been followed to exclude relevant vaginal/uterine infections prior to starting treatment 7. Expected good ovarian reserve as assessed clinically and or laboratory (normal early follicular FSH (<10) & normal AMH) and no history of previous radiotherapy or chemotherapy 8. Expected good responders in whom blastocyst transfer is expected (as assessed by clinical judgement) 9. Understands/willing to comply with the protocol 10. Willing to use a condom if randomised to Endometrial Scratch (ES) in the cycle where the ES procedure is performed |
| Participant exclusion criteria | 1. Single embryo transfer is not anticipated 2. Previous trauma/surgery to the endometrium e.g. resection of submucous fibroid, intrauterine adhesions 3. BMI≥ 35 kg/m2 4. Known Grade 4 (severe) endometriosis 5. Women who have received cycle programming through the use of progestogens or the contraceptive pill in the lead up to their IVF treatment and for whom a wash out period of one month will not be possible 6. Currently participating in any other fertility study or a study involving medical/surgical intervention or previously randomised into this trial |
| Recruitment start date | 01/07/2016 |
| Recruitment end date | 31/12/2018 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
ScHARR
Regent Court
30 Regent Street
Sheffield
S1 4DA
United Kingdom
Sponsor information
Hospital/treatment centre
Northern General Hospital
Herries Road
Sheffield
S5 7AU
England
United Kingdom
"ROR" |
https://ror.org/018hjpz25 |
|---|
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 | 30/09/2021 |
|---|---|
| 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 | Not provided at time of registration |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol article | protocol | 20/05/2018 | 17/05/2019 | Yes | No |
| Results article | 18/06/2021 | 01/06/2021 | Yes | No | |
| Results article | Qualitative results | 16/09/2021 | 21/09/2021 | Yes | No |
| Results article | 01/01/2022 | 08/02/2022 | Yes | No | |
| HRA research summary | 28/06/2023 | No | No |
Editorial Notes
08/02/2022: Publication reference added.
21/09/2021: Publication reference added.
01/06/2021: The following changes were made to the trial record:
1. Publication reference added.
2. The total final enrolment was added.
17/05/2019: Publication reference added.
01/11/2017: Internal review.
