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IRCT20200421047152N2 IRCT 2023-01-30 Iran University of Medical Sciences Effect of endometrial Scratching on pregnancy outcome after intrauterine insemination Effect of endometrial Scratching on pregnancy outcome after intrauterine insemination (IUI) in patients with previous IUI failure, a randomized clinical trial 2023-01-20 anticipated 192 Complete https://irct.ir/trial/67801 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Stratified randomization will be done according to age (above and below 35 years) and using permuted blocks with a size of 4. The random list is generated by the website www.sealedenvelope.com software and will be given to an independent third party for concealment and will be revealed to the researcher respectively, Blinding description: Patients will be aware of being in a study with two groups, with and without endometrial scraping, but will not know whether endometrial scraping is being performed for them. To reach this goal patients in the control group will undergo a vaginal examination with a speculum and a cervical scraper will enter into the posterior fornix without scratching. Patients in the control group will not be informed about the intervention type. 3 Infertility needs intrauterine insemination (IUI). Intervention 1: Endometrial scratching intervention group: Endometrial scratching is done in the intrauterine sperm injection (IUI) cycle on day 5 or 6 from the beginning of the menstrual cycle. To perform endometrial scratching, the patient is placed in a lithotomy position. Then, the speculum is slowly placed in the vagina to expose the cervix, and with the use of a flexible catheter, the endometrium is scratched in a circular position after performing aspiration. The circular movement of the catheter starts and ends in 12 o'clock position, and then the catheter is removed. If the catheter does not pass through the tenaculum, the anterior edge of the cervix is used to grasp the. According to the level of Anti-Müllerian Hormone (AMH) and Ovarian Reserve Count (AFC), letrozole, Cinnal F, or Menstrual Gonadotropin (HMG) is used to stimulate the ovaries, depending on the initial response to stimulation. After starting the drugs, the follicle size is monitored. When the size of the follicles is greater than or equal to 18, two ampoules of human chorionic gonadotropin (HCG) are prescribed to release the egg, and the patient undergoes IUI after 36 hours. Intervention 2: Control group: Patients in this group will undergo a vaginal examination with a speculum and a cervical scraper will enter into the posterior fornix without scratching. According to the level of Anti-Müllerian Hormone (AMH) and Ovarian Reserve Count (AFC), letrozole, Cinnal F, or Menstrual Gonadotropin (HMG) is used to stimulate the ovaries, depending on the initial response to stimulation. After starting the drugs, the follicle size is monitored. When the size of the follicles is greater than or equal to 18, two ampoules of human chorionic gonadotropin (HCG) are prescribed to release the egg, and the patient undergoes IUI after 36 hours. No - There is not a plan to make this available Justification or reason for not sharing IPD is There is no further information.
public Behnaz Mohabatian
Bagh-ferdous station, Molavi street
Tehran Iran (Islamic Republic of) 1168743514 +98 21 86709 dr.mohabatian@gmail.com Iran University of Medical Sciences scientific Mahnaz Ashrafi
Bagh-ferdous station, Molavi street
Tehran Iran (Islamic Republic of) 1168743514 +98 21 86709 ashrafi.m@iums.ac.ir Iran University of Medical Sciences Iran (Islamic Republic of) Age 20-42 year Unexplained infertility or mild male factor infertility Failure of at least two previous intrauterine insemination (IUI) cycles 20 years 42 years Female Presence of endometriosis in stage 3 and 4 diagnosed by ultrasound Sever male factor infertility Underlying metabolic disease (hyperprolactinemia, thyroid disorder or any known metabolic disease) Ovarian follicle-stimulating hormone (FSH) level > 12 Body mass measurement > 30 Z31.1 Artificial insemination Treatment - Surgery Treatment - Surgery Endometrial scratching intervention group: Endometrial scratching is done in the intrauterine sperm injection (IUI) cycle on day 5 or 6 from the beginning of the menstrual cycle. To perform endometrial scratching, the patient is placed in a lithotomy position. Then, the speculum is slowly placed in the vagina to expose the cervix, and with the use of a flexible catheter, the endometrium is scratched in a circular position after performing aspiration. The circular movement of the catheter starts and ends in 12 o'clock position, and then the catheter is removed. If the catheter does not pass through the tenaculum, the anterior edge of the cervix is used to grasp the. According to the level of Anti-Müllerian Hormone (AMH) and Ovarian Reserve Count (AFC), letrozole, Cinnal F, or Menstrual Gonadotropin (HMG) is used to stimulate the ovaries, depending on the initial response to stimulation. After starting the drugs, the follicle size is monitored. When the size of the follicles is greater than or equal to 18, two ampoules of human chorionic gonadotropin (HCG) are prescribed to release the egg, and the patient undergoes IUI after 36 hours. Control group: Patients in this group will undergo a vaginal examination with a speculum and a cervical scraper will enter into the posterior fornix without scratching. According to the level of Anti-Müllerian Hormone (AMH) and Ovarian Reserve Count (AFC), letrozole, Cinnal F, or Menstrual Gonadotropin (HMG) is used to stimulate the ovaries, depending on the initial response to stimulation. After starting the drugs, the follicle size is monitored. When the size of the follicles is greater than or equal to 18, two ampoules of human chorionic gonadotropin (HCG) are prescribed to release the egg, and the patient undergoes IUI after 36 hours. Clinical pregnancy rate. Timepoint: 5-6 weeks after IUI. Method of measurement: Transvaginal sonography. Live birth rate. Timepoint: 28 weeks of pregnancy. Method of measurement: Phone based interview. Chemical pregnancy rate. Timepoint: 14 days after IUI. Method of measurement: Measurement of beta human chorionic gonadotropin serum level (Beta HCG). Iran University of Medical Sciences Approved 2023-01-11 IUMS Biomedical Research Ethics Committee Next to Milad Tower ,Hemat Highway Tehran Tehran Iran (Islamic Republic of)