Condition category
Pregnancy and Childbirth
Date applied
11/01/2012
Date assigned
12/04/2012
Last edited
12/04/2012
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Prof Caihong Ma

ORCID ID

Contact details

Reproductive Medical Center
Peking University Third Hospital
Beijing
100191
China

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Effect of endometrial injury 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 injury compared with patients without endometrial injury.

Ethics approval

Peking University Third Hospital Ethics Committee, Beijing, China, 01 November 2011 ref: Shengzhi010

Study design

Prospective randomised controlled study

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Screening

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 fifth day after ovulation prior to an IVF or 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 injury before IVF-ET or FET.
Study group: patients with RIF undergoing endometrial injury before IVF-ET or FET.

Intervention type

Other

Phase

Not Specified

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
3. Blood flow under endometrium

Overall trial start date

05/11/2011

Overall trial end date

31/12/2012

Reason abandoned

Eligibility

Participant inclusion criteria

1. Patients with repeated implantation failure (three or more) undergoing in vitro fertilization embryo transfer (IVF-ET) or frozen embryo transfer (FET)
2. Patients with normal preoperative routine checks
3. Patients aged 40 years old or younger with basal follicle-stimulating hormone (FSH)<10IU/L and numbers of follicles>5 in hibateral ovaries
4. Patients without history of uterine cavity operation in two months

Participant type

Patient

Age group

Adult

Gender

Female

Target number of participants

400

Participant exclusion criteria

1. Patients with hydrosalpinx
2. Patients with history of endometrium adhesion
3. Patients with uterine malformation
4. Patients with acute genital tract inflammation
5. Patients with history of using hormone such as oral contraceptive in three months

Recruitment start date

05/11/2011

Recruitment end date

31/12/2012

Locations

Countries of recruitment

China

Trial participating centre

Reproductive Medical Center
Beijing
100191
China

Sponsor information

Organisation

Peking University Third Hospital (China)

Sponsor details

48
Huayuan Bei Road
Haidian District
Beijing
100191
China

Sponsor type

Hospital/treatment centre

Website

http://www.at0086.com/PUTH/

Funders

Funder type

Hospital/treatment centre

Funder name

Peking University Third Hospital, Beijing (China)

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