This study is a randomized, single-blind clinical trial conducted in parallel and single-center. The aim of this study is to evaluate the effect of mechanical injury on pregnancy rate. Patients aged between 15 to 40 years old are enrolled in the study based on inclusion criteria. Inclusion criteria are 1 or 2 previous failure in IVF and normal uterine cavity and, all women with known intrauterine factors and active vaginal and cervical infection are excluded from study.
Our sample size is 70 who are randomly allocated into two groups. In intervention group, patients are treated with Local endometrial injury (LEI) with standard Pipelle biopsy before IVF procedure in luteal phase of menstrual cycle. Then patients are treated with increasing dose of 2, 3 and 4 mg progesterone valerate suppository for 14 days. After transvaginal sonography, if endometrial thickness is more than 7 mm, progesterone cyclogest is administered and 5 days later embryo transfer is done. In control group IVF procedure is performed without LEI. The researcher is blinded to the treatment of two groups before IVF. After IVF, the rate of clinical and chemical pregnancy is analyzed between two groups.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201604261556N89
Registration date:2016-12-28, 1395/10/08
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2016-12-28, 1395/10/08
Registrant information
Name
Shahin Akhondzadeh
Name of organization / entity
Roozbeh Psychiatric Hospital, Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 5541 2222
Email address
s.akhond@sina.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellor for Research, Tehran University of Medical Science
Expected recruitment start date
2016-12-24, 1395/10/04
Expected recruitment end date
2017-03-20, 1395/12/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of local endometrial injury in women with one and two failure history in IVF cycle on success rate of embryo implantation and pregnancy
Public title
Effect of local endometrial injury in women with unsuccessful IVF improve on pregnancy rate
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Age<40 years old; normal uterine cavity in hysteroscopy and Hysterosalpingography in last year; BMI<30; one or two IVF failure; not taking OCP or GnRH for FET in past cycle; patient had indication for EI
Exclusion criteria: known intrauterine factors in sonography or imaging as fibroma ; endometrial hyperplasia ; cancer; active vaginal and cervical infection; presence of hydrosalpinx or systemic disorders
Age
From 15 years old to 40 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
70
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Randomization is based on randomized blocks.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Tehran University of Medical Science
Street address
Qods Street, Keshavarz Bulevard
City
Tehran
Postal code
Approval date
2015-10-29, 1394/08/07
Ethics committee reference number
IR.TUMS.REC.1394.1289
Health conditions studied
1
Description of health condition studied
infertility
ICD-10 code
Z31.2
ICD-10 code description
Admission for harvesting or implantation of ova
Primary outcomes
1
Description
pregnancy
Timepoint
2 weeks after IVF
Method of measurement
beta HCG test
2
Description
implantation
Timepoint
5 weeks after IVF
Method of measurement
sonography
Secondary outcomes
empty
Intervention groups
1
Description
In intervention group, patients are treated with Local endometrial injury (LEI) with standard Pipelle biopsy before IVF procedure in luteal phase of menstrual cycle.Then patients are treated with increasing dose of 2, 3 and 4 mg progesterone valerate suppository for 14 days. After trans vaginal sonography, if endometrial thickness is more than 7 mm, progesterone cyclogest is administered and 5 days later embryo transfer is done.
Category
Treatment - Other
2
Description
Control group: IVF procedure is performed without LEI.