Condition category
Urological and Genital Diseases
Date applied
16/01/2013
Date assigned
19/02/2013
Last edited
19/02/2013
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Although the results of in vitro fertilization-embryo transfer (IVF-ET) have been steadily increasing over recent years, it still means that approximately 6 out of 10 of women are unable to successfully conceive with each treatment cycle. It also follows that approximately 2 out of 10 women will fail to conceive after two or three IVF attempts. Recurrent implantation failure (RIF) is a most distress situation. Several studies (the number of cases included was quite small) reported that endometrial scratch is of benefit to improve the pregnancy outcome of women with RIF. A recent analysis of data has shown that large studies are required before endometrial scratch or injury can be warranted in routine clinical practice. Hence, we wish to conduct such a study to evaluate if endometrial scratch does have impact on the IVF treatment outcome in women with two or more embryo transfer failures.

Who can participate?
Patients with repeated implantation failure (two or more) undergoing in vitro fertilization embryo transfer (IVF-ET) or frozen embryo transfer (FET), patients aged no more than 40 years old with basal follicle-stimulating hormone (FSH)<10IU/L and without history of uterine cavity operation in two months.

What does the study involve?
Patients fulfilling the inclusion criteria will be randomly allocated to two groups
Group 1, endometrial scratch was offered on day of observation of Luteinizing hormone (LH) + 7 immediately prior to commencement of IVF treatment
Group 2, no endometrial scratch was performed.

What are the possible benefits and risks of participating?
Endometrial scratch might improve the potential of embryo implantation. The side effect is associated with injury to the endometrium, such as bleeding, pain and infection, however, there are no reports related to the risks mentioned above.

Where is the study run from?
Reproductive medical center of Sir Run Run Shaw hospital, medical school, Zhejiang university, China.

When is the study starting and how long is it expected to run for?
The study was started on January 1, 2013 and will run for 2 years or until 800 patients were included.

Who is funding the study?
National Natural Science Foundation of China.

Who is the main contact?
Prof Songying Zhang
zhangsongying @126.com
zhangsongying@zju.edu.cn

Trial website

Contact information

Type

Scientific

Primary contact

Prof Zhang Songying

ORCID ID

Contact details

Assisted Reproduction Unit
Department of Obstetrics and Gynecology
Sir Run Run Shaw Hospital
College of Medicine
Zhejiang University
3# Qing Chun East Road
Hangzhou
310016
China

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Effect of endometrial scratch on repeat implantation failure following in vitro fertilization embryo transfer or frozen embryo transfer: a randomized controlled study

Acronym

Study hypothesis

Patients with repeated implantation failure (RIF) have a higher implantation rate and pregnancy rate following in vitro fertilization embryo transfer (IVF-ET) or frozen embryo transfer (FET) after undergoing endometrial scratch compared with patients without endometrial scratch.

Ethics approval

Assisted Reproduction Unit, Department of Obstetrics and Gynecology, Sir Run Run Shaw Hospital, College of Medicine, Zhejiang University,Hangzhou, China, 15 January 2013

Study design

Prospective randomized controlled study

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

Infertility

Intervention

Endometrium scratching in seventh day after observation of Luteinizing hormone (LH) surge prior to an IVF or frozen embryo transfer (FET) cycle in study group. No extra administration prior to an IVF or FET cycle in control group.

Control group: patients with RIF without endometrial scratch before IVF-ET or FET.

Study group: patients with RIF undergoing endometrial scratch before IVF-ET or FET.

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

1. Implantation rate
2. Clinical pregnancy rate defined as the presence of a fetal sac by ultrasound scanning

Secondary outcome measures

1. Endometrial thickness
2. Endometrial type

Overall trial start date

16/01/2013

Overall trial end date

31/12/2014

Reason abandoned

Eligibility

Participant inclusion criteria

1. Patients with repeated implantation failure (two or more) undergoing in vitro fertilization embryo transfer (IVF-ET) or frozen embryo transfer (FET)
2. Patients aged no more than 40 years old
3. Patients with basal follicle-stimulating hormone (FSH)<10IU/L
4. Patients without history of uterine cavity operation in two months

Participant type

Patient

Age group

Adult

Gender

Female

Target number of participants

800

Participant exclusion criteria

1. Patients with hydrosalpinx
2. Patients with polycystic ovary syndrome (PCOS)
3. Patients with history of endometrium adhesion
4. Patients with uterine malformation; uterine fibroid
5. Patients with acute genital tract inflammation
6. Patients with history of using hormone such as oral contraceptive in one month

Recruitment start date

16/01/2013

Recruitment end date

31/12/2014

Locations

Countries of recruitment

China

Trial participating centre

Assisted Reproduction Unit
Hangzhou
310016
China

Sponsor information

Organisation

Zhejiang University (China)

Sponsor details

c/o Songying Zhang
Assisted Reproduction Unit
Department of Obstetrics and Gynecology
Sir Run Run Shaw Hospital
College of Medicine
3# Qing Chun East Road
Hangzhou
310016
China

Sponsor type

Hospital/treatment centre

Website

Funders

Funder type

Hospital/treatment centre

Funder name

Zhejiang University (China) - Assisted Reproduction Unit, Department of Obstetrics and Gynecology, Sir Run Run Shaw Hospital

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