Protocol summary
-
Study aim
-
Effect local scratch endometrium on outcome pregnancy in women with previous failure intrauterine insemination
-
Design
-
interventional study that was conducted on a non_randomized clinical trials in infertility center during 6 months.336patients 173 case,163control
-
Settings and conduct
-
336women with infertile women in are divided into two groups of173and163 patients.the group referring to infertility clinic on odd days,is consulted to participate in design and intervention,and after receiving informed consenton 8-9 days of menstrual cycle,endometrial scratch using Pipelle catheter is performed,but patients referring in even days, will be without any intervention and are divided into control group.On the 14th day after IUI,the biochemical pregnancy rate is measured with positive beta-test.
-
Participants/Inclusion and exclusion criteria
-
Infertility women with one or two history of failure in IUI or IO who are planning to have a pregnancy and are candidates for IUI.Inclusion criteria:Patients are candidates for induction ovulation and intrauterine insemination.Normalized thyroid and prolactin function tests.Age range18 to 40 years.BMI<30kg/m2,and1<AMH<3.5,Having at least one healthy fallopian tube and normal uterine cavity. Normalized semen fluid or mild oligospermia,.Exclusion criteria:No consent to participate in the study.Poor Response patients(AMH<1ng/dl) Disturbance thyroid function and high prolactin.double blocked fallopian tubes or hydrosalpinx,and those with polycystic ovarian disease(PCOD)
-
Intervention groups
-
receiveing or not receiving endometer scratch using paipel divided into two groups of control and scratch
-
Main outcome variables
-
Comparison of success rate of pregnancy in the two groups
General information
-
Reason for update
-
Change in the inclusion and exclusion criteria to increase accuracy in selected sample cases of study and change in the number of sample and change in the time of study due to the large number of samples and prolonged duration of sampling
-
Acronym
-
-
IRCT registration information
-
IRCT registration number:
IRCT20180731040659N1
Registration date:
2018-09-03, 1397/06/12
Registration timing:
prospective
Last update:
2021-03-06, 1399/12/16
Update count:
2
-
Registration date
-
2018-09-03, 1397/06/12
-
Registrant information
-
-
Recruitment status
-
Recruitment complete
-
Funding source
-
-
Expected recruitment start date
-
2019-05-10, 1398/02/20
-
Expected recruitment end date
-
2019-11-28, 1398/09/07
-
Actual recruitment start date
-
empty
-
Actual recruitment end date
-
empty
-
Trial completion date
-
empty
-
Scientific title
-
Effect of local scratch of endometrium on the outcome of pregnancy in women with the previous failure of intrauterine insemination
-
Public title
-
Effect of local scratch of endometrium on the outcome of pregnancy
-
Purpose
-
Treatment
-
Inclusion/Exclusion criteria
-
Inclusion criteria:
Inclusion criteria of the study were:infertility women with one or two history of failure in IUI or IO who are planning to have a pregnancy and are candidates for IUI despite proper ovolation and primary and secondary infirtility with having at least one patent fallopian tube,women eged18_40years BMI<30kg/m2and1<AMH<3.5with normal thyroid and prolactin funtional tests،normal semen analysis,and mild oligospermia
Exclusion criteria:
Exclusion criteria,. No consent to participate in the study, Poor Response patients(AMH<1ng/dl) Disturbance of thyroid function and high prolactin, double blocked fallopian tubes or hydrosalpinx), People with polycystic ovary disease(PCOD)
-
Age
-
From 18 years old to 40 years old
-
Gender
-
Female
-
Phase
-
N/A
-
Groups that have been masked
-
No information
-
Sample size
-
Target sample size:
336
-
Randomization (investigator's opinion)
-
Not randomized
-
Randomization description
-
-
Blinding (investigator's opinion)
-
Not blinded
-
Blinding description
-
-
Placebo
-
Not used
-
Assignment
-
Parallel
-
Other design features
-
Ethics committees
1
-
Ethics committee
-
-
Approval date
-
2018-06-17, 1397/03/27
-
Ethics committee reference number
-
IR.ZAUMS.REC.1397.144
Health conditions studied
1
-
Description of health condition studied
-
Infertility
-
ICD-10 code
-
-
ICD-10 code description
-
Primary outcomes
1
-
Description
-
Pregnancy
-
Timepoint
-
On the 14th day after IUI, the biochemical pregnancy rate is measured
-
Method of measurement
-
Serum pregnancy test
Intervention groups
1
-
Description
-
Intervention group: on based receiving or no receiving endometrial scratch using paipel is divided
-
Category
-
Treatment - Devices
1
-
Sponsor
-
-
Grant name
-
-
Grant code / Reference number
-
-
Is the source of funding the same sponsor organization/entity?
-
Yes
-
Title of funding source
-
Zahedan University of Medical Sciences
-
Proportion provided by this source
-
100
-
Public or private sector
-
Public
-
Domestic or foreign origin
-
Domestic
-
Category of foreign source of funding
-
empty
-
Country of origin
-
-
Type of organization providing the funding
-
Academic
Sharing plan
-
Deidentified Individual Participant Data Set (IPD)
-
Undecided - It is not yet known if there will be a plan to make this available
-
Study Protocol
-
Undecided - It is not yet known if there will be a plan to make this available
-
Statistical Analysis Plan
-
Undecided - It is not yet known if there will be a plan to make this available
-
Informed Consent Form
-
Undecided - It is not yet known if there will be a plan to make this available
-
Clinical Study Report
-
Undecided - It is not yet known if there will be a plan to make this available
-
Analytic Code
-
Undecided - It is not yet known if there will be a plan to make this available
-
Data Dictionary
-
Undecided - It is not yet known if there will be a plan to make this available