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

ISRCTN	ISRCTN63112626
DOI	https://doi.org/10.1186/ISRCTN63112626
Protocol serial number	N/A
Sponsor	Peking University Third Hospital (China)
Funder	Peking University Third Hospital, Beijing (China)

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Prof Caihong Ma
Scientific

Reproductive Medical Center
Peking University Third Hospital
Beijing
100191
China

Primary study design	Interventional
Study design	Prospective randomised controlled study
Secondary study design	Randomised controlled trial
Study type	Participant information sheet
Scientific title	Effect of endometrial injury on repeat implantation failure following in vitro fertilization embryo transfer or frozen embryo transfer: a randomized controlled study
Study objectives	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(s)	Peking University Third Hospital Ethics Committee, Beijing, China, 01 November 2011 ref: Shengzhi010
Health condition(s) or problem(s) studied	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
Primary outcome measure(s)	1. Implantation rate 2. Clinical pregnancy rate defined as the presence of a fetal sac by ultrasound scanning
Key secondary outcome measure(s)	1. Endometrial thickness 2. Endometrial type 3. Blood flow under endometrium
Completion date	31/12/2012

Participant type(s)	Patient
Age group	Adult
Sex	Female
Target sample size at registration	400
Key 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
Key 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
Date of first enrolment	05/11/2011
Date of final enrolment	31/12/2012

Reproductive Medical Center

Beijing
100191
China

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes