Pre In vitro fertilisation (IVF) pipelle biopsy following a previous unsuccessful IVF cycle

ISRCTN	ISRCTN09447850
DOI	https://doi.org/10.1186/ISRCTN09447850
Secondary identifying numbers	N/A

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

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

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

Dr Garima Srivastava
Scientific

Fertility Unit
Homerton University Hospital
London
E9 6SR
United Kingdom

Study information

Study design	Single centre randomised controlled trial
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 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	Clinical pregnancy rate
Secondary outcome measures	Implantation rate (number of embryos transferred divided by number of pregnancies)
Overall study start date	25/04/2012
Completion date	25/10/2012

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	Female
Target number of participants	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

England
United Kingdom

Study participating centre

Fertility Unit

London
E9 6SR
United Kingdom

Sponsor information

Homerton University Hospital
Hospital/treatment centre

c/o Mr Roger Griffith
Research and Development Department
London
E9 6SR
England
United Kingdom

"ROR"	https://ror.org/00x444s43

Funders

Funder type

Hospital/treatment centre

Homerton University Hospital NHS Trust (UK)

No information available

Results and Publications

Intention to publish date
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

Editorial Notes

13/02/2018: No publications found in PubMed, verifying study status with principal investigator.
30/11/2015: No publications found in PubMed.