Condition category
Pregnancy and Childbirth
Date applied
26/04/2012
Date assigned
07/06/2012
Last edited
30/11/2015
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

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

Trial website

Contact information

Type

Scientific

Primary contact

Dr Garima Srivastava

ORCID ID

Contact details

Fertility Unit
Homerton University Hospital
London
E9 6SR
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

A randomised controlled study of pre IVF pipelle biopsy of the endometrium in women with previous unsuccessful IVF treatment

Acronym

Study hypothesis

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

NRES Committee London - Harrow, 16th March 2012

Study design

Single centre randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

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

Phase

Not Applicable

Drug names

Primary outcome measures

Clinical pregnancy rate

Secondary outcome measures

Implantation rate (number of embryos transferred divided by number of pregnancies)

Overall trial start date

25/04/2012

Overall trial end date

25/10/2012

Reason abandoned

Eligibility

Participant 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

Participant type

Patient

Age group

Adult

Gender

Female

Target number of participants

128

Participant exclusion criteria

1. Age less than 23 and more than 37 years
2. Previous poor quality embryos

Recruitment start date

25/04/2012

Recruitment end date

25/10/2012

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Fertility Unit
London
E9 6SR
United Kingdom

Sponsor information

Organisation

Homerton University Hospital

Sponsor details

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

Sponsor type

Hospital/treatment centre

Website

Funders

Funder type

Hospital/treatment centre

Funder name

Homerton University Hospital NHS Trust (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes

30/11/2015: No publications found in PubMed.