]>
IRCT2015042912307N4 IRCT 2015-06-15 Tehran University of Medical Sciences To assess the effect of oral melatonin administration on clinical outcomes in women undergoing in-vitro fertilisation (IVF) To assess the effect of oral melatonin administration on clinical outcomes in women undergoing in-vitro fertilisation (IVF) 2015-03-20 anticipated 90 Complete https://irct.ir/trial/12397 interventional Randomization: Not randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Other design features: Design: a single blind non-randomized controlled clinical trial study, and Parallel, Blinding description: The patients, embryologist and outcome assessor were blinded to assignment. The physicians was not blind. 2 infertility. Intervention 1: Intervention group: Oral melatonin tablet is administered to 45 women undergoing IVF as an intervention group. Daily melatonin dosage is 3 mg orally (nature made,USA) taken at 22:00 pm. The written informed consent is taken from all of the patients. ََAdministration of melatonin begins from the 21th day of the previous menstrual cycle until the day of oocyte retrieval. Patients undergo in vitro fertilization with a standardized ovarian-stimulation protocol, GnRH agonist. The daily administration of Buserelin acetate (Suprefact, Germany) 500 μg is started preceding the IVF cycle from day 21. Ovarian stimulation is started on the 3rd day of the current menstrual cycle by injection of rFSH Follitropin alfa (Gonal F, Italy) at a daily dose of 150 to 225 IU in each group. Administration of Buserelin is continued until hCG is injected. When at least 3 follicles with a mean diameter of 17 mm are developed (evaluated by transvaginal sonography), hCG (Choriomon, Switzerland) 5000 IU/2/IM is injected. About 34–36 after hCG injection, oocyte retrieval is performed. Intervention 2: control group: Oral melatonin tablet is not administered to 45 women undergoing IVF as a control group. We do not use a placebo in the control group due to logistic restraints. The same of intervention group, Patients undergo in vitro fertilization with a standardized ovarian-stimulation protocol, GnRH agonist. The daily administration of Buserelin acetate 500 (Suprefact, Germany) μg is started preceding the IVF cycle from day 21. Ovarian stimulation is started on the 3rd day of the current menstrual cycle by injection of rFSH Follitropin alfa (Gonal F, Italy) at a daily dose of 150 to 225 IU in each group. Administration of Buserelin is continued until hCG is injected. When at least 3 follicles with a mean diameter of 17 mm are developed (evaluated by transvaginal sonography), hCG (Choriomon, Switzerland) 5000 IU/2/IM is injected. About 34–36 after hCG injection, oocyte retrieval is performed. Yes - There is a plan to make this available What will be shared: Age/ the cause of infertility/ the count and stage of oocytes When: from 06/2019 to 6 mouth later To whom: scientific person in university Conditions: I don't have any idea Where to obtain: Fshoseini@sina.tums.ac.ir How to obtain: after e-mailing Comments:
public Fatemeh Sadat Hoseini
Tehran Women General Hospital, Shomali Negatollahi St., Karim Khan Blvd., Tehran
Tehran Iran (Islamic Republic of) 3439123900 +98 21 8890 7062 fshoseini@sina.tums.ac.ir Tehran University of Medical Sciences scientific Azra Azmoodeh
Tehran yas Hospital, Shomali Negatollahi St., Karim Khan Blvd., Tehran
Tehran Iran (Islamic Republic of) 3439123900 +98 21 8890 7062 Azraazmoodeh@yahoo.com Tehran University of Medical Sciences Iran (Islamic Republic of) Age 18-40 yrs.; normal level of serum steroidal hormones; agonist long protocol of controlled ovarian stimulation; male factor; tubal factor; and unexplained infertility. 18 years 40 years Female Myoma; a congenital uterine anomaly; use of estrogens; progesterone; androgens; or chronic use of any medication; including nonsteroidal anti-inflammatory agents or anticonvulsants, smoking; severe endometriosis. N97 female infertility Treatment - Drugs Treatment - Drugs Intervention group: Oral melatonin tablet is administered to 45 women undergoing IVF as an intervention group. Daily melatonin dosage is 3 mg orally (nature made,USA) taken at 22:00 pm. The written informed consent is taken from all of the patients. ََAdministration of melatonin begins from the 21th day of the previous menstrual cycle until the day of oocyte retrieval. Patients undergo in vitro fertilization with a standardized ovarian-stimulation protocol, GnRH agonist. The daily administration of Buserelin acetate (Suprefact, Germany) 500 μg is started preceding the IVF cycle from day 21. Ovarian stimulation is started on the 3rd day of the current menstrual cycle by injection of rFSH Follitropin alfa (Gonal F, Italy) at a daily dose of 150 to 225 IU in each group. Administration of Buserelin is continued until hCG is injected. When at least 3 follicles with a mean diameter of 17 mm are developed (evaluated by transvaginal sonography), hCG (Choriomon, Switzerland) 5000 IU/2/IM is injected. About 34–36 after hCG injection, oocyte retrieval is performed. control group: Oral melatonin tablet is not administered to 45 women undergoing IVF as a control group. We do not use a placebo in the control group due to logistic restraints. The same of intervention group, Patients undergo in vitro fertilization with a standardized ovarian-stimulation protocol, GnRH agonist. The daily administration of Buserelin acetate 500 (Suprefact, Germany) μg is started preceding the IVF cycle from day 21. Ovarian stimulation is started on the 3rd day of the current menstrual cycle by injection of rFSH Follitropin alfa (Gonal F, Italy) at a daily dose of 150 to 225 IU in each group. Administration of Buserelin is continued until hCG is injected. When at least 3 follicles with a mean diameter of 17 mm are developed (evaluated by transvaginal sonography), hCG (Choriomon, Switzerland) 5000 IU/2/IM is injected. About 34–36 after hCG injection, oocyte retrieval is performed The mean number of the oocytes. Timepoint: oocyte pick up day. Method of measurement: Microscopic assay. The mean metaphase II (MII) oocyte counts. Timepoint: oocyte pick up day. Method of measurement: Microscopic assay. The degenerate oocyte counts. Timepoint: oocyte pick up day. Method of measurement: Microscopic assay. The fertilization rate. Timepoint: 24 hours after ICSI. Method of measurement: Microscopic assay. The embryo quality. Timepoint: 24 hours after ICSI. Method of measurement: Microscopic assay. MRNA level of MT-ATP6 gene incumulus cells. Timepoint: after sampling. Method of measurement: q-PCR. The biochemical pregnancy rate. Timepoint: 2 weeks after embryo transfer. Method of measurement: ٍُSerum B.hCG titter. Tehran University of Medical Sciences Approved 2014-01-12 Ethics committee of Tehran University of Medical Sciences Poorsina St., Keshavarz Blvd. Tehran Tehran Tehran Iran (Islamic Republic of)