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
Secondary identifying numbers	N/A

Submission date: 11/01/2012
Registration date: 12/04/2012
Last edited: 12/04/2012

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Pregnancy and Childbirth

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

Contact information

Prof Caihong Ma
Scientific

Reproductive Medical Center
Peking University Third Hospital
Beijing
100191
China

Study information

Study design	Prospective randomised controlled study
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Hospital
Study type	Screening
Participant information sheet	Not available in web format, please use the contact details below to request a patient 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	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 study start date	05/11/2011
Completion date	31/12/2012

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	Female
Target number of participants	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

Locations

Countries of recruitment

China

Study participating centre

Reproductive Medical Center

Beijing
100191
China

Sponsor information

Peking University Third Hospital (China)
Hospital/treatment centre

48, Huayuan Bei Road
Haidian District
Beijing
100191
China

Website	http://www.at0086.com/PUTH/
"ROR"	https://ror.org/04wwqze12

Funders

Funder type

Hospital/treatment centre

Peking University Third Hospital, Beijing (China)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan