Effect of endometrial scratch on repeat implantation failure following in vitro fertilization embryo transfer or frozen embryo transfer

ISRCTN ISRCTN24605402
DOI https://doi.org/10.1186/ISRCTN24605402
Secondary identifying numbers N/A
Submission date
16/01/2013
Registration date
19/02/2013
Last edited
19/02/2013
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Urological and Genital Diseases
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year

Plain English summary of protocol

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

Contact information

Prof Zhang Songying
Scientific

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

Study information

Study designProspective randomized controlled study
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typeTreatment
Participant information sheet Not available in web format, please use the contact details below to request a patient information sheet
Scientific titleEffect of endometrial scratch on repeat implantation failure following in vitro fertilization embryo transfer or frozen embryo transfer: a randomized controlled study
Study objectivesPatients 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(s)Assisted Reproduction Unit, Department of Obstetrics and Gynecology, Sir Run Run Shaw Hospital, College of Medicine, Zhejiang University,Hangzhou, China, 15 January 2013
Health condition(s) or problem(s) studiedInfertility
InterventionEndometrium 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 typeOther
Primary outcome measure1. Implantation rate
2. Clinical pregnancy rate defined as the presence of a fetal sac by ultrasound scanning
Secondary outcome measures1. Endometrial thickness
2. Endometrial type
Overall study start date16/01/2013
Completion date31/12/2014

Eligibility

Participant type(s)Patient
Age groupAdult
SexFemale
Target number of participants800
Key inclusion criteria1. 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
Key exclusion criteria1. 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
Date of first enrolment16/01/2013
Date of final enrolment31/12/2014

Locations

Countries of recruitment

  • China

Study participating centre

Assisted Reproduction Unit
Hangzhou
310016
China

Sponsor information

Zhejiang University (China)
Hospital/treatment centre

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

ROR logo "ROR" https://ror.org/00a2xv884

Funders

Funder type

Hospital/treatment centre

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

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan