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IRCT201108024339N4 IRCT 2011-08-15 Yazd University of Medical Sciences The efficacy of alcohol injection in endometrioma The comparison of the efficacy of ethanol injection with no ethanol injection on pregnancy outcome in IVF cycles among patients with recurrent endometrioma 2011-03-01 anticipated 40 Complete https://irct.ir/trial/4618 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Women with recurrent endometrioma who met the inclusion criteria were were informed about the research design and signed a written consent form for randomly assignment into either case or control groups. Randomization was simple, individual using a random number table. All women were consecutively divided into two groups based on the randomized list. 2-3 endometriosis. Intervention 1: Intervention group: 20 patients with recurrent endometrioma go through sclerotherapy under vaginal sonography guidance . The needle is introduced into endometrioma and aspiration is done under sonographic guidance. The endometrioma is irrigated with sterile normal saline till the fluid is clear in color. The endometrioma is filled with 98% ethanol for 10 minute and at the end ethanol is aspirated. Then the patients were followed up after one week, one, two, and three months. At this time If the patients have no any endometrioma they are treated with IVF long protocol. Intervention 2: Control group: 20 patients with recurrent endometrioma go through IVF long protocol who do not treated by ethanol sclerotherapy. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3943218/ Background: Endometriosis is a common hormone-dependent gynecologic disease with a high recurrence. Laparotomy or laparoscopy is the standard surgery for the large endometrioma. Also, sclerotherapy is basically used to treat different diseases one of which is endometrioma. Objective: The study was designed to assess the value of transvaginal ultrasound-guided ethanol sclerotherapy in patients with a recurrent endometrioma. Materials and Methods:In a randomized clinical trial, an interventional group of 20 patients underwent transvaginal ethanol sclerotherapy for recurrent ovarian endometrioma. The patients were followed up first after one and two weeks and then after one, two, and three months. If the patients had no endometrioma, they were treated with in vitro fertilization (IVF) (standard long protocol). A control group of 20 patients with endometrioma were enrolled for an IVF protocol. They had no treatment by ethanol sclerotherapy. IVF parameters, pregnancy rates, and implantation rates were compared in both groups. Results: The demographic data showed no difference between the two groups. The initial mean endometria size was 41.45±15.9 cm, the recurrence rate after 6 months was 4 (20%), FSH before and after sclerotherapy was 6.97±2.25 IU/L and 6.78±1.88 IU/L (p=0.343). The clinical pregnancy rate was 6 (33.3%) vs. 3 (15%), (p=0.616). The fertilization rate emerged 63.06% in study group vs. 60.38%, (p=0.57). The implantation rate turned out 12.9% in study group vs. 7.5%, (p=0.52). None of these results were significant. However, the data pointed to a better trend toward the ethanol sclerotherapy group. Conclusion:Ethanol sclerotherapy could be an effective strategy for the treatment of recurrent endometrioma especially before IVF. 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 Due to the privacy of patients
public Abbas Aflatoonian
Yazd research and clinical center for infertility, Booali Street, Safaieh, Yazd
Yazd Iran (Islamic Republic of) 8916877391 +98 35 1824 7085 abbas_aflatoonian@yahoo.com Yazd University of Medical Sciences scientific Prof.Abbas Aflatoonian
Yazd research and clinical center for infertility, Booali Street, Safaieh, Yazd
Yazd Iran (Islamic Republic of) 8916877391 +98 35 1824 7085 aflatoonian@yazdivf.org Yazd University of Medical Sciences Iran (Islamic Republic of) Being at the age of 20 to 39 years Past history of operation on endometrioma with recurrent unilateral endometrioma Recurrent endometrioma more than 30 mm FSH<10 20 years 39 years Female liver or kidney or heart diseases sever male factor infertility N80.1 اندومتریوز تخمدان Treatment - Drugs Treatment - Drugs Intervention group: 20 patients with recurrent endometrioma go through sclerotherapy under vaginal sonography guidance . The needle is introduced into endometrioma and aspiration is done under sonographic guidance. The endometrioma is irrigated with sterile normal saline till the fluid is clear in color. The endometrioma is filled with 98% ethanol for 10 minute and at the end ethanol is aspirated. Then the patients were followed up after one week, one, two, and three months. At this time If the patients have no any endometrioma they are treated with IVF long protocol. Control group: 20 patients with recurrent endometrioma go through IVF long protocol who do not treated by ethanol sclerotherapy. The size of endometrioma. Timepoint: One week ; one, two, three and six months after surgery. Method of measurement: sonography. Chemical pregnancy. Timepoint: 14 days after embryo transfer. Method of measurement: serum BHCG. Fertilization rates. Timepoint: Three days after fertilization. Method of measurement: The total number of embryos created is divided by the number of second metaphase oocytes multiplied by 100. Implantation rates. Timepoint: Five weeks after transfer. Method of measurement: The number of gestational sacs divided by the number of transferred embryos multiplied by 100. Clinical pregnancy rate. Timepoint: 7 weeks after embryo transfer. Method of measurement: Fetal heart rate in ultra sonography. Yazd University of Medical Sciences Approved 2011-06-20 Yazd research and clinical center for infertility Yazd research and clinical center for infertility, Booali Street, Safaieh, Yazd Yazd Yazd Iran (Islamic Republic of)