Comparison effect of endometrial abrasion on the success of intrauterine sperm injection in both follicular and luteal phases in infertile women with unexplained infertility
Comparison effect of endometrial abrasion on the success of intrauterine sperm injection in two phases of follicular and luteal in infertile women with unexplained infertility
Design
This is a double blind, phase 3 randomized control clinical trial study that done on 75 women with infertility for unexplained reasons. Patients are distributed in three groups of 25 people using Random Allocation Software.
Settings and conduct
This double blind clinical trial study will be done in 2020-2021 in Shahid Beheshti Hospital in Isfahan. The study is double blind and patients were unaware of the endometrial abrasion phase. Also, the person evaluating the fertility outcome is unaware of the endometrial abrasion step.
Participants/Inclusion and exclusion criteria
Inclusion criteria: age range of participants 38-21 years old; body mass index 29.9-18.5 kg / m2; normal hormonal tests (FSH less than 10 mIU / ml on days 2-3); normal thyroid status; bilateral tubal opening Follows in HSG or laparoscopy.
Exclusion criteria: presence of adnexal mass in transvaginal ultrasound; normal fluid analysis of semen with a volume of 2–5 ml with a concentration of more than 20 million / ml; total motility greater than 50% and normal form more than 30%; spousal infections severe infertility; stage 3 and 4 endometriosis; infertility caused by defects in the fallopian tubes; levels of thyroid-stimulating hormone greater than 10 mL / ml; abnormal levels of thyroid hormone or prolactin; uterine fibroids or severe systemic or infectious disease.
Intervention groups
The intervention in this study on patients is endometrial abrasion, which is performed either in the follicular phase or in the luteal phase. Endometrial abrasion control is not performed. All patients are treated with intrauterine sperm injection.
Main outcome variables
Fertility success
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20130311012782N48
Registration date:2020-06-15, 1399/03/26
Registration timing:prospective
Last update:2020-06-15, 1399/03/26
Update count:0
Registration date
2020-06-15, 1399/03/26
Registrant information
Name
Ali Mehrabi kushki
Name of organization / entity
Isfahan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 31 3629 1510
Email address
mehrabi@mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-08-22, 1399/06/01
Expected recruitment end date
2021-09-21, 1400/06/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison effect of endometrial abrasion on the success of intrauterine sperm injection in both follicular and luteal phases in infertile women with unexplained infertility
Public title
The effect of endometrial abrasion in both follicular and luteal stages on fertility success by intrauterine sperm injection
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Range age between 21-38 years old
Body Mass Index between 18.5-29.9 kg/m2
Levels of thyroid stimulating hormone less than 10 meq/ml in 2 to 3 days
Normal thyroid condition
Bilateral opening of fallopian tubes in HSG or laparoscopy
Exclusion criteria:
Existence of adnexal mass in transvaginal ultrasound
Normal analysis of Semen liquid with a volume of 2-5 ml with a concentration of more than 20 million / ml
Total sperm motility more than 50%
Natural sperm form more than 30%
husband with severe infertility
Stages 3 and 4 endometriosis
Infertility due to defects in the fallopian tubes
Abnormal thyroid hormone or prolactin levels
Uterine fibroids or severe systemic or infectious disease
Age
From 21 years old to 38 years old
Gender
Female
Phase
3
Groups that have been masked
Participant
Outcome assessor
Sample size
Target sample size:
75
Randomization (investigator's opinion)
Randomized
Randomization description
Patients with entry criteria are divided into three groups using Random Allocation Software. In this way, first the total sample size is entered into the software and then the number of groups is determined. Software output includes a list that randomly distributed sample size (75 people) in three groups A, B, and C. Patients are distributed in three groups according to the list, according to the time of referral, so that the sample size reaches the required number.
Blinding (investigator's opinion)
Double blinded
Blinding description
This study is double blind clinical trial study. Patients and outcome assessors are unaware of the type of intervention received. Endometrial abrasion was performed by the researcher without informing the patient in the follicular or luteal phase, but the outcome of the pregnancy was checked by a gynecologist who was not awareness about this.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Isfahan University of Medical Sciences