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
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 measure
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 (if study stopped)
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
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
Basic results (scientific)
Publication list