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
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
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