Endometrial injury prior to first cycle IVF/ICSI

ISRCTN	ISRCTN61316186
DOI	https://doi.org/10.1186/ISRCTN61316186
Secondary identifying numbers	153052012

Submission date: 04/06/2015
Registration date: 22/06/2015
Last edited: 08/06/2015

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
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

Contact information

Dr Ahmad Mahran
Scientific

Department of Obstetrics and Gynecology
Faculty of Medicine
Minia University
Minia
61111
Egypt

Phone	00201115551073
Email	ezzeldin_ahmad@yahoo.com

Study information

Study design	Randomized 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 contact details to request a participant information sheet
Scientific title	The effect of endometrial injury on first cycle IVF/ICSI outcome: a randomized controlled trial.
Study objectives	Endometrial injury performed in the luteal phase of the cycle preceding to IVF/ ICSI improves clinical pregnancy and live birth rates.
Ethics approval(s)	Ethical Committee of the Faculty of Medicine, Minia University, Egypt, 02/05/2012
Health condition(s) or problem(s) studied	Outcome of IVF / ICSI cycles.
Intervention	Endometrial scratch performed in the cycle preceding the IVF/ICSI cycle
Intervention type	Procedure/Surgery
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 study start date	01/06/2012
Completion date	01/09/2014

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	Female
Target number of participants	400
Key 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
Key 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
Date of first enrolment	01/06/2012
Date of final enrolment	01/09/2013

Locations

Countries of recruitment

Egypt

Study participating centres

Minia infertility research unit

Minia
61111
Egypt

Minia IVF unit

Minia
61111
Egypt

Sponsor information

Department of Obstetrics and Gynecology
University/education

Faculty of Medicine
Minia University
Minia
61111
Egypt

"ROR"	https://ror.org/02hcv4z63

Funders

Funder type

University/education

Department of Obstetrics and Gynecology, Faculty of Medicine, Minia University, Minia, Egypt

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	Yes
IPD sharing plan summary	Available on request
Publication and dissemination plan
IPD sharing plan