Plain English Summary
Background and study aims
It is possible that scratching the inside of the womb lining before in vitro fertilisation (IVF) could increase pregnancy rates. However, recent studies have not provided sufficient information in order to conclude that this is the case. The aim of this study is to find out if scratching of the womb lining increases the likelihood of pregnancy after the IVF or intra-cytoplasmic sperm injection (ICSI) treatment.
Who can participate?
Patients undergoing first cycle IVF / ICSI.
What does the study involve?
The patients are randomly allocated to one of two groups. Those in group 1 (intervention group) have the inside of their womb scratched before being given their fertility treatment. Those in group 2 (control) do not have the inside of their womb scratched before treatment.
What are the possible benefits and risks of participating?
There is the possible benefit of improving the chance of getting pregnant after IVF. There is a minimal risk of pain or vaginal bleeding during or after the procedure.
Where is the study run from?
Minia Infertility Research Unit and Minia IVF Unit, Minia, Egypt
When is study starting and how long is it expected to run for?
June 2012 to September 2013.
Who is funding the study?
Obstetrics and Gynecology department, Faculty of Medicine, Minia University (Egypt)
Who is the main contact?
Dr Ahmad Mahran
ezzeldin_ahmad@yahoo.com
Trial website
Contact information
Type
Scientific
Primary contact
Dr Ahmad Mahran
ORCID ID
Contact details
Department of Obstetrics and Gynecology
Faculty of Medicine
Minia University
Minia
61111
Egypt
00201115551073
ezzeldin_ahmad@yahoo.com
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
153052012
Study information
Scientific title
The effect of endometrial injury on first cycle IVF/ICSI outcome: a randomized controlled trial.
Acronym
Study hypothesis
Endometrial injury performed in the luteal phase of the cycle preceding to IVF/ ICSI improves clinical pregnancy and live birth rates.
Ethics approval
Ethical Committee of the Faculty of Medicine, Minia University, Egypt, 02/05/2012
Study design
Randomized 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 contact details to request a participant information sheet
Condition
Outcome of IVF / ICSI cycles.
Intervention
Endometrial scratch performed in the cycle preceding the IVF/ICSI cycle
Intervention type
Procedure/Surgery
Phase
Drug names
Primary outcome measure
1. Live birth rate; calculated as the ration of number of patients with live births divided by the number of patients who had embryo transfer
2. Implantation rate; calculated as number of gestational sacs evident by ultrasound divided by the number of transferred embryos
Secondary outcome measures
1. Clinical pregnancy rate; calculated as the number of patients with clinical pregnancy divided by the number of patients who had embryo transfer
2. Miscarriage rate per clinical pregnancy; calculated as the number of patients who had miscarriage divided by the number of patients who had clinical pregnancies
3. Multiple gestations rate; calculated as the number of patients who had multiple gestation divided by the number of patients who had clinical pregnancies
4. Pain; reported pain during the intervention
5. Bleeding; reports of abnormal bleeding during or after the intervention
Overall trial start date
01/06/2012
Overall trial end date
01/09/2014
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Age between 20-40 years
2. FSH ≤ 12
3. Normal uterine cavity by hysteroscopy (done routinely for all cases prior to ICSI)
4. ≥ 2 good quality embryos replaced
Participant type
Patient
Age group
Adult
Gender
Female
Target number of participants
400
Participant exclusion criteria
1. Age > 40 years
2. Abnormal uterine cavity due to submucous fibroid, endometrial polyps, Asherman’s syndrome or congenital uterine malformations
3. Patients who have < 2 good quality embryos at time of transfer were excluded from the analysis
Recruitment start date
01/06/2012
Recruitment end date
01/09/2013
Locations
Countries of recruitment
Egypt
Trial participating centre
Minia infertility research unit
Minia
61111
Egypt
Trial participating centre
Minia IVF unit
Minia
61111
Egypt
Funders
Funder type
University/education
Funder name
Department of Obstetrics and Gynecology, Faculty of Medicine, Minia University, Minia, Egypt
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Intention to publish date
Participant level data
Available on request
Basic results (scientific)
Publication list