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IRCT201106116689N2 IRCT 2012-11-05 Vice Chancellor for Research, Tehran University of Medical Sciences Treatment of endometrioma in infertile women Comparison of ovarian response to ovulation induction after laparoscopic cystectomy or medical management among infertile women with endometrioma undergoing assisted reproductive technology 2012-01-04 anticipated 80 Complete https://irct.ir/trial/7099 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Other design features: All volenteers with inclusion criteria are asked to participate in the current study if agreed, a informed consent form is signed. she is randomly assigned to one of two groups based in Bertoli distribution. If she has an objection, we will switch her to another group. N/A Condition 1: Infertility. Condition 2: Endometriomas. Intervention 1: First group receives 3 consecutive single IM doses of Dipherelin 3.75mg (Beaufouipfen, France) in 3 consecutive months.Ten days after the third IM dose of Dipherelin ovarian stimulation is conducted by using Gonal F (Serono, Switzerland, 300-450IU daily), for one week. Then Gonal F is replaced by HMG (Ferring, Germany, 300-450IU daily) until the observation of 18mm follicles in trans vaginal ultrasound. For visualizing follicular development, trans vaginal ultrasound (Sonoline G20; Siemens Medical Solutions, California, USA) is performed every 4 days. After the observation of at least two 18mm follicles, HCG (Ferring Co, Germany, 10000IU, IM) is injected and after 36 hours oocyte retrieve is performed under general anesthesia. Three days after fertilization technique performed through intra cytoplasmic sperm injection (ICSI), trans cervical embryo transfer will be carried out. Detection of pregnancy is through serum BhCG analysis, 3 days after embryonic transfer and the clinical pregnancy is detected by the aid of trans vaginal ultrasound, two weeks later when the pregnancy sac is detected. Main outcome is the number of oocytes retrieved. The number of oocytes retrieved, dominant follicles, embryos; quality of embryos;the rate of fertilization, laboratory and clinical pregnancy are compared between two groups. Intervention 2: Second group receives 3 consecutive single IM doses of Dipherelin 3.75mg (Beaufouipfen, France) in 3 consecutive months after laparoscopic ovarian cystectomy. Ten days after the third IM dose of Dipherelin ovarian stimulation is conducted by using Gonal F (Serono, Switzerland, 300-450IU daily), for one week. Then Gonal F is replaced by HMG (Ferring, Germany, 300-450IU daily) until the observation of 18mm follicles in trans vaginal ultrasound. For visualizing follicular development, trans vaginal ultrasound (Sonoline G20, Siemens Medical Solutions, California, USA) is performed every 4 days. After observing at least two 18mm follicles, HCG (Ferring Co, Germany, 10000IU, IM) is injected and after 36 hours oocyte retrieve is performed under general anesthesia. Three days after fertilization technique performed through intra cytoplasmic sperm injection (ICSI), trans cervical embryo transfer is carried out. Detection of pregnancy is through serum BhCG analysis, 3 days after embryonic transfer and the clinical pregnancy is detected by the aid of trans vaginal ultrasound, two weeks later when the pregnancy sac is detected. Main outcome is the number of oocytes retrieved. The number of oocytes retrieved, dominant follicles, embryos; quality of embryos;the rate of fertilization, laboratory and clinical pregnancy are compared between two groups.
public Dr Sedighe Hoseinimosa
Infertility Department, Shariati Hospital, North Karegar Street, Tehran
Tehran Iran (Islamic Republic of) 1411713135 +98 21 8800 8810 hoseinimosa@razi.tums.ac.ir Tehran University of Medical Sciences, Shariati Hospital, Department of Infertility scientific Dr Leili Safdarian
Infertility Department, Shariati Hospital, North Karegar Street, Tehran
Tehran Iran (Islamic Republic of) 1411713135 +98 21 8800 8810 safdarian@sina.tums.ac.ir Tehran University of Medical Sciences Iran (Islamic Republic of) Inclusion criteria: Infertile women with endometrioma requiring assisted reproductive technology Exclusion criteria: Age over 40 years; Endometrioma smaller than 2 cm or larger than 6 cm; Male infertility TESE (Testicular Sperm Extraction) or PESA (Percutaneous Epididimal Sperm Aspiration) 20 years 40 years Female N97 N80.1 ناباروري زنانه اندومتريوزيزدرتخمدان Treatment - Drugs Treatment - Surgery First group receives 3 consecutive single IM doses of Dipherelin 3.75mg (Beaufouipfen, France) in 3 consecutive months.Ten days after the third IM dose of Dipherelin ovarian stimulation is conducted by using Gonal F (Serono, Switzerland, 300-450IU daily), for one week. Then Gonal F is replaced by HMG (Ferring, Germany, 300-450IU daily) until the observation of 18mm follicles in trans vaginal ultrasound. For visualizing follicular development, trans vaginal ultrasound (Sonoline G20; Siemens Medical Solutions, California, USA) is performed every 4 days. After the observation of at least two 18mm follicles, HCG (Ferring Co, Germany, 10000IU, IM) is injected and after 36 hours oocyte retrieve is performed under general anesthesia. Three days after fertilization technique performed through intra cytoplasmic sperm injection (ICSI), trans cervical embryo transfer will be carried out. Detection of pregnancy is through serum BhCG analysis, 3 days after embryonic transfer and the clinical pregnancy is detected by the aid of trans vaginal ultrasound, two weeks later when the pregnancy sac is detected. Main outcome is the number of oocytes retrieved. The number of oocytes retrieved, dominant follicles, embryos; quality of embryos;the rate of fertilization, laboratory and clinical pregnancy are compared between two groups. Second group receives 3 consecutive single IM doses of Dipherelin 3.75mg (Beaufouipfen, France) in 3 consecutive months after laparoscopic ovarian cystectomy. Ten days after the third IM dose of Dipherelin ovarian stimulation is conducted by using Gonal F (Serono, Switzerland, 300-450IU daily), for one week. Then Gonal F is replaced by HMG (Ferring, Germany, 300-450IU daily) until the observation of 18mm follicles in trans vaginal ultrasound. For visualizing follicular development, trans vaginal ultrasound (Sonoline G20, Siemens Medical Solutions, California, USA) is performed every 4 days. After observing at least two 18mm follicles, HCG (Ferring Co, Germany, 10000IU, IM) is injected and after 36 hours oocyte retrieve is performed under general anesthesia. Three days after fertilization technique performed through intra cytoplasmic sperm injection (ICSI), trans cervical embryo transfer is carried out. Detection of pregnancy is through serum BhCG analysis, 3 days after embryonic transfer and the clinical pregnancy is detected by the aid of trans vaginal ultrasound, two weeks later when the pregnancy sac is detected. Main outcome is the number of oocytes retrieved. The number of oocytes retrieved, dominant follicles, embryos; quality of embryos;the rate of fertilization, laboratory and clinical pregnancy are compared between two groups. The number of retrieved oocytes. Timepoint: 84 days after the first Dipherelin injection. Method of measurement: Invert Microscope, Diaphot 300, Nikon, Japan. The number of dominant follicles. Timepoint: 82 days after the first Dipherelin injection. Method of measurement: nGS= number of observed gestatinal sac in trans vaginal sonography, nET= number of embryonal transfer, clinical pregnancy rate(%)= nGS/ nET x100. Fertilization rate. Timepoint: 87 days after the first Dipherelin injection. Method of measurement: nE= number of total embryos, nI= number of injected oocytes, fertilization rate(%)= nE/ nI x 100. The number and quality of embryos. Timepoint: 87 days after the first Dipherelin injection. Method of measurement: Invert Microscope, Diaphot 300, Nikon, Japan. Chemical pregnancy. Timepoint: 101 days after the first Dipherelin injection. Method of measurement: βhCG test. Clinical pregnancy rate. Timepoint: 115 days after the first Dipherelin injection. Method of measurement: nGS= number of observed gestatinal sac in trans vaginal sonography, nET= number of embryonal transfer, clinical pregnancy rate(%)= nGS/ nET x100. Vice Chancellor for Research, Tehran University of Medical Sciences Approved 2012-01-02 Ethic Committee of Tehran University of Medical Sciences Ethic Committee, Tehran University of Medical Sciences, Poorsina Street, Tehran Tehran Iran (Islamic Republic of)