Condition category
Pregnancy and Childbirth
Date applied
04/06/2015
Date assigned
22/06/2015
Last edited
08/06/2015
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

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 measures

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

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

Sponsor information

Organisation

Department of Obstetrics and Gynecology

Sponsor details

Faculty of Medicine
Minia University
Minia
61111
Egypt

Sponsor type

University/education

Website

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

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes