Pre In vitro fertilisation (IVF) pipelle biopsy following a previous unsuccessful IVF cycle
| ISRCTN | ISRCTN09447850 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN09447850 |
| Protocol serial number | N/A |
| Sponsor | Homerton University Hospital |
| Funder | Homerton University Hospital NHS Trust (UK) |
- Submission date
- 26/04/2012
- Registration date
- 07/06/2012
- Last edited
- 13/02/2018
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Pregnancy and Childbirth
Plain English summary of protocol
Background and study aims
Management of implantation failure (i.e. attaching of the embryo to the lining of the womb) despite transfer of good quality embryos remains challenging in IVF clinics. Recent studies suggests that the outcome of the in vitro fertilisation (IVF) treatment can be improved if a gentle scratching is done to the lining of the womb before the treatment cycle.
We propose a gentle scratching to the lining of the womb in the cycle before the IVF cycle by a simple outpatient procedure to see if it improves the pregnancy rates.
Who can participate?
Women between 23-37 years of age undergoing an IVF cycle with a history of one or more previous unsuccessful IVF cycles despite having good quality embryos transfered.
What does the study involve?
Local scratching of the endometrium (lining of the womb) of 64 patients in the cycle before the IVF treatment cycle, who were selected by computer generated randomised numbers from a total of 128 patients. The gentle scratching (biopsy) is to be performed on Day 21 of the cycle preceding IVF, after informed consent. The other 64 patients with no intervention will serve as controls. The biopsy is done using a pipelle sampler which is a flexible transparent polypropylene sheath. The procedure requires no local anesthesia or cervical dilatation.
What is the possible benefits and risks of participating?
There are no added disadvantages and risks over and above the routine IVF treatment. The pipelle biopsy sampler is an extremely safe outpatient procedure, however, some women experience light period pain during the sampling and maybe some discharge after the procedure.
We cannot promise the study will help you but the information we get from this study will help improve the treatment of people with IVF failure despite the transfer of good quality embryos.
Where is the study run from?
Homerten Fertility Centre, Homerton University Hospital, London, UK
When is the study starting?
May 2012. The study is expected to run for six months.
Who is funding the study?
Homerton Fertility Centre.
Who is the main contact?
Dr G Srivastava
garima.srivastava@homerton.nhs.uk
Contact information
Scientific
Fertility Unit
Homerton University Hospital
London
E9 6SR
United Kingdom
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Single centre randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| Study type | Participant information sheet |
| Scientific title | A randomised controlled study of pre IVF pipelle biopsy of the endometrium in women with previous unsuccessful IVF treatment |
| Study objectives | Does the gentle scratching to the lining of the womb in the cycle preceding IVF result in a higher clinical pregnancy rate (a fetal heart beat seen on ultrasound examination) in the subsequent IVF treatment cycle? |
| Ethics approval(s) | NRES Committee London - Harrow, 16/03/2012 |
| Health condition(s) or problem(s) studied | Subfertility |
| Intervention | Intervention group: Local scratching of the endometrium (lining of the womb) of 64 patients in the cycle before the IVF treatment cycle. The biopsy is to be performed on Day 21 of the cycle preceding IVF, after informed consent. It is done by a pipelle sampler which is a flexible transparent polypropylene sheath. The procedure requires no local anesthesia or cervical dilatation. Control group - No intervention |
| Intervention type | Other |
| Primary outcome measure(s) |
Clinical pregnancy rate |
| Key secondary outcome measure(s) |
Implantation rate (number of embryos transferred divided by number of pregnancies) |
| Completion date | 25/10/2012 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Female |
| Target sample size at registration | 128 |
| Key inclusion criteria | 1. Between 23- 37 years of age 2. At least one previous unsuccessful IVF cycle 3. At least one good quality embryo transferred in the previous unsuccessful cycle |
| Key exclusion criteria | 1. Age less than 23 and more than 37 years 2. Previous poor quality embryos |
| Date of first enrolment | 25/04/2012 |
| Date of final enrolment | 25/10/2012 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
E9 6SR
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
Editorial Notes
13/02/2018: No publications found in PubMed, verifying study status with principal investigator.
30/11/2015: No publications found in PubMed.
