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IRCT201106026689N1 IRCT 2014-05-16 Vice Chancellor for Research, Tehran University of Medical Sciences Choice of Treatments for Ovulation Induction Among Poor Responders Comparison of ovarian response to ovulation induction after "Minidose long agonist" and "GnRH-agonist/GnRH-antagonist" protocols among poor responder infertile women who undergoing assisted reproductive technology 2012-01-21 anticipated 100 Complete https://irct.ir/trial/7098 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Other design features: All volunteers with inclusion criteria are asked to participate in the current study if agreed; an informed consent form is signed. She is randomly assigned to one of two groups based in Bernoulli distribution. Initially, patients and physicians were blinded to the treatment group. 3 Female infertility. Intervention 1: First group, Minidose Agonist, receives GnRH Agonist (Bucerelin, Aventis, Germany) 50 μg subcutaneously from midluteal cycle (21th day). Ovarian stimulation is conducted by using Gonal F (Serono, Switzerland) 375-600IU daily, for one week. Then Gonal F is replaced by HMG (Ferring, Germany, 300-600IU daily) until the observation of 18mm follicles in transvaginal ultrasound. For visualizing follicular development, trans vaginal ultrasound (Sonoline G20; Siemens Medical Solutions, California, USA) is performed every 3 days. After the observation of at least two 18mm follicles, HCG (Ferring Co, Germany, 10000IU and IM) is injected and after 36 hours oocyte retrieve is performed under general anesthesia. Three days after fertilization technique, performed through intracytoplasmic sperm injection (ICSI), trans cervical embryo transfer will be carried out. Detection of pregnancy is through serum BhCG analysis, 16 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 dominant follicles, embryos; quality of embryos; the rate of fertilization, chemical and clinical pregnancy are compared between two groups. Intervention 2: Second group receives Decapeptyle 0.1mg (Ferring, Germany) in 3 consecutive days from the first day of menses. In the third day of menses ovarian stimulation is conducted by using Gonal F (Serono, Switzerland) and HMG (Ferring, Germany) 375-600IU daily. When the 14mm follicles is observed in transvaginal ultrasound GnRH antagonist (Cetrorelix, Ferring, Germany) 0.25mg daily is added. For visualizing follicular development, trans vaginal ultrasound (Sonoline G20; Siemens Medical Solutions, California, USA) is performed every 3 days. After the observation of at least two 18mm follicles, HCG (Ferring Co, Germany, 10000IU and 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, 16 days after embryonal 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 dominant follicles, embryos; quality of embryos; the rate of fertilization, chemical and clinical pregnancy, cancellation 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 Marzieh Aghahosseini
Infertility Department, Shariati Hospital, North Karegar Street, Tehran
Tehran Iran (Islamic Republic of) 1411713135 +98 21 8800 8810 aghahosseini@sina.tums.ac.ir Tehran University of Medical Sciences Iran (Islamic Republic of) Inclusion Criteria: Infertile women with at least two episodes of poor responses following maximal stimulation or at least two of the following three conditions: 1- Advanced maternal age (40 years old or greater) 2- A history of IVF failure ( retrieved 3 oocytes or less) 3- An abnormal ovarian reserve test (Antral Follicle Count 5 or lesser in early follicular phase or Antimulerian hormone less than 1mIU/ml) Exclusion Criteria: 1-Male infertility which needs interventions such as TESE (Testicular Sperm Extraction) or PESA (Percutaneous Epididymal Sperm Aspiration) 2- Endometriosis (stage 3 or 4) 3- Uterine myoma with 4cm size or greater 4- maternal age greater than 43 years old 20 years 43 years Female N97 Female infertility associated with anovulation Treatment - Drugs Treatment - Drugs First group, Minidose Agonist, receives GnRH Agonist (Bucerelin, Aventis, Germany) 50 μg subcutaneously from midluteal cycle (21th day). Ovarian stimulation is conducted by using Gonal F (Serono, Switzerland) 375-600IU daily, for one week. Then Gonal F is replaced by HMG (Ferring, Germany, 300-600IU daily) until the observation of 18mm follicles in transvaginal ultrasound. For visualizing follicular development, trans vaginal ultrasound (Sonoline G20; Siemens Medical Solutions, California, USA) is performed every 3 days. After the observation of at least two 18mm follicles, HCG (Ferring Co, Germany, 10000IU and IM) is injected and after 36 hours oocyte retrieve is performed under general anesthesia. Three days after fertilization technique, performed through intracytoplasmic sperm injection (ICSI), trans cervical embryo transfer will be carried out. Detection of pregnancy is through serum BhCG analysis, 16 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 dominant follicles, embryos; quality of embryos; the rate of fertilization, chemical and clinical pregnancy are compared between two groups. Second group receives Decapeptyle 0.1mg (Ferring, Germany) in 3 consecutive days from the first day of menses. In the third day of menses ovarian stimulation is conducted by using Gonal F (Serono, Switzerland) and HMG (Ferring, Germany) 375-600IU daily. When the 14mm follicles is observed in transvaginal ultrasound GnRH antagonist (Cetrorelix, Ferring, Germany) 0.25mg daily is added. For visualizing follicular development, trans vaginal ultrasound (Sonoline G20; Siemens Medical Solutions, California, USA) is performed every 3 days. After the observation of at least two 18mm follicles, HCG (Ferring Co, Germany, 10000IU and 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, 16 days after embryonal 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 dominant follicles, embryos; quality of embryos; the rate of fertilization, chemical and clinical pregnancy, cancellation are compared between two groups. The number of retrieved oocytes. Timepoint: The day of oocyte retrieval. Method of measurement: Invert Microscope, Diaphot 300, Nikon, Japan. Chemical Pregnancy. Timepoint: 19 days after oocyte retrieval. Method of measurement: βhCG titration. The number of dominant follicles. Timepoint: 48 hours prior to oocyte retrieval. Method of measurement: Transvaginal ultrasonography. The number and quality of embryos. Timepoint: 48 hours after oocyte retrieval. Method of measurement: Invert Microscope, Diaphot 300, Nikon, Japan. Clinical pregnancy rate. Timepoint: 33 days after oocyte retrieval. Method of measurement: observed gestational sac in transvaginal sonography. Fertilization Rate. Timepoint: The day after oocyte retrieval. Method of measurement: (Total number of embryos/ Total number of injected oocytes)* 100. Cancellation rate of cycle. Timepoint: Any time. Method of measurement: the number of cycles not resulted in oocyte retrieval. Vice Chancellor for Research, Tehran University of Medical Sciences Approved 2010-08-20 Ethics Committee of Tehran University of Medical Sciences Ethics Committee, Tehran University of Medical Sciences, Poorsina Street, Tehran Tehran Iran (Islamic Republic of)