]>
IRCT20130311012782N48 IRCT 2020-06-15 Esfahan University of Medical Sciences The effect of endometrial abrasion in both follicular and luteal stages on fertility success by intrauterine sperm injection Comparison effect of endometrial abrasion on the success of intrauterine sperm injection in both follicular and luteal phases in infertile women with unexplained infertility 2020-08-22 anticipated 75 Complete https://irct.ir/trial/48506 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, 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 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. 3 Unexplained infertility. Intervention 1: Intervention group 1: Uterine abrasion between days 19 and 24 of the menstrual cycle before intrauterine injection of sperm and in the luteal phase. Intervention 2: Intervention group 2: Uterine endometrial abrasion on day 8 of the menstrual cycle and in the follicular phase before intrauterine injection of sperm. Intervention 3: Control group: no uterine endometrial abrasion in 3 menstrual cycles and only Intrauterian Sperm Injection. No - There is not a plan to make this available Justification or reason for not sharing IPD is The project belongs to a government agency and cannot be shared.
public Mina Ghaed Amini
Shahid Beheshti hospital, Motahari street, Isfahan, Iran
Isfahan Iran (Islamic Republic of) 8434193474 +98 21 3236 7001 ghaedamini@gmail.com Esfahan University of Medical Sciences scientific Elham Naghshineh
Shahid Beheshti hospital, Motahari street, Isfahan, Iran
Isfahan Iran (Islamic Republic of) 8434193474 +98 21 3236 7001 naghshineh@med.mui.ac.ir Esfahan University of Medical Sciences Iran (Islamic Republic of) 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 21 years 38 years Female 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 N97.9 Female infertility, unspecified Treatment - Surgery Treatment - Surgery Treatment - Surgery Intervention group 1: Uterine abrasion between days 19 and 24 of the menstrual cycle before intrauterine injection of sperm and in the luteal phase Intervention group 2: Uterine endometrial abrasion on day 8 of the menstrual cycle and in the follicular phase before intrauterine injection of sperm Control group: no uterine endometrial abrasion in 3 menstrual cycles and only Intrauterian Sperm Injection Fertility success. Timepoint: 6 months after intervention. Method of measurement: Measurement of beta HCg and vaginal ultrasonography. Esfahan University of Medical Sciences Approved 2020-01-03 Ethics committee of Isfahan University of Medical Sciences Shahid Beheshti hospital, Motahari street, Isfahan, Iran Isfahan Isfehan Iran (Islamic Republic of)