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IRCT20140224016705N11 IRCT 2021-11-05 Shahid Beheshti University of Medical Sciences Evaluating the effects of local endometrial injury on success of pregnancy rate in patients candidate for in vitro fertilization. Evaluating the effects of local endometrial injury on success of pregnancy rate in patients candidate for in vitro fertilization (IVF). 2021-07-23 anticipated 324 Complete https://irct.ir/trial/58590 interventional Randomization: N/A, Blinding: Not blinded, Placebo: Not used, Assignment: Single, Purpose: Treatment. N/A Infertility. Intervention 1: Intervention group: Includes infertile women with at least one failed IVF history and re-candidate for IVF referred to the Reproductive Clinic of Mahdieh Hospital in Tehran, whose endometrial thickness is based on inappropriate ultrasound criteria (echogenic or thin view with a thickness of less than 5 mm) and in ultrasound or hysteroscopy of internal pathology They will not have a uterus such as a myoma or fibroid. Patients are routinely involved in the IVF process and ovulation and in vitro fertilization will be performed for each patient. The initial ultrasound will be done before the intervention in the luteal phase (about a week before the next period). Then, on the first to third day of the cycle, small blows were applied to different parts of the uterus using a pipette and small scratches were created. On day 8-10 of the cycle, ultrasound was performed again and the condition of the endometrium was examined. If there is a triple line view or a thickness of more than 7 mm, while starting progesterone as a cyclogest suppository, the patient is introduced for embryo transfer to be done in two or three days. Β-hCG titers were also checked 2 weeks after embryo transfer. Also, 5 weeks after the transfer, the presence of clinical pregnancy (formation of pregnancy sac and fetal heart) will be examined by transvaginal ultrasound. Outcomes studied include the effect of endometrial abrasion on endometrial condition adaptation, β-hCG positivity (greater than 10 mIU / mL) and the presence of clinical pregnancy with ultrasound. Intervention 2: Control group: Each patient is considered as a control group. In this way, each patient is classified as a control group according to the infertility conditions in terms of uterine endometrial diameter before the intervention. Conditions before and after endometrial ablation with papillae in terms of uterine diameter and fertility will be evaluated as case and control groups. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is According to the results, local application is considered regionally
public zahra heidar
Mahdieh hospital,Fadaeean Eslam street,Shoosh square
tehran Iran (Islamic Republic of) 1185817311 +98 21 5506 2628 dr_zheidar@yahoo.com Shahid Beheshti University of Medical Sciences scientific zahra heidar
Mahdieh hospital,Fadaeean Eslam street,Shoosh square
tehran Iran (Islamic Republic of) 1185817311 +98 21 5506 2628 dr_zheidar@yahoo.com Shahid Beheshti University of Medical Sciences Iran (Islamic Republic of) History of infertility with a history of unsuccessful IVF candidate for in vitro fertilization Existence of inappropriate endometrial thickness based on ultrasound Age 40 years or less Do not use OCP or GnRH for FET in the previous cycle Appropriate quality of embryos for transfer 18 years 40 years Female Vaginal or cervical active infection Endometrial Hyperplasia Existence of endometritis Presence of known intrauterine pathologies on ultrasound or hysteroscopy such as fibroids or myomas Asherman syndrome Uterine anomaly N97 Female infertility Treatment - Devices N/A Intervention group: Includes infertile women with at least one failed IVF history and re-candidate for IVF referred to the Reproductive Clinic of Mahdieh Hospital in Tehran, whose endometrial thickness is based on inappropriate ultrasound criteria (echogenic or thin view with a thickness of less than 5 mm) and in ultrasound or hysteroscopy of internal pathology They will not have a uterus such as a myoma or fibroid. Patients are routinely involved in the IVF process and ovulation and in vitro fertilization will be performed for each patient. The initial ultrasound will be done before the intervention in the luteal phase (about a week before the next period). Then, on the first to third day of the cycle, small blows were applied to different parts of the uterus using a pipette and small scratches were created. On day 8-10 of the cycle, ultrasound was performed again and the condition of the endometrium was examined. If there is a triple line view or a thickness of more than 7 mm, while starting progesterone as a cyclogest suppository, the patient is introduced for embryo transfer to be done in two or three days. Β-hCG titers were also checked 2 weeks after embryo transfer. Also, 5 weeks after the transfer, the presence of clinical pregnancy (formation of pregnancy sac and fetal heart) will be examined by transvaginal ultrasound. Outcomes studied include the effect of endometrial abrasion on endometrial condition adaptation, β-hCG positivity (greater than 10 mIU / mL) and the presence of clinical pregnancy with ultrasound. Control group: Each patient is considered as a control group. In this way, each patient is classified as a control group according to the infertility conditions in terms of uterine endometrial diameter before the intervention. Conditions before and after endometrial ablation with papillae in terms of uterine diameter and fertility will be evaluated as case and control groups. Existence of clinical pregnancy (formation of pregnancy sac and fetal heart) in IVF patient under the intervention of endometrial abrasion with papillae. Timepoint: 5 weeks after the transfer, transvaginal ultrasound will examine the presence of clinical pregnancy (formation of pregnancy sac and fetal heart). Method of measurement: transvaginal ultrasound. β-hCG positivity (greater than 10 mIU / mL). Timepoint: Β-hCG titer was checked 2 weeks after embryo transfer. Method of measurement: Using a laboratory-approved β-hCG test. The effect of endometrial abrasion on endometrial condition. Timepoint: On day 8-10 of the cycle, an ultrasound will be performed again and the condition of the endometrium will be examined. Method of measurement: transvaginal ultrasound. Shahid Beheshti University of Medical Sciences Approved 2021-01-31 Ethics committee of Shahid Beheshti University of Medical Sciences Shahid Beheshti university of medical sciences, Arabi Ave, Yamen St, Chamran Highway, Tehran Tehran Tehran Iran (Islamic Republic of)