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IRCT20200328046881N1 IRCT 2020-04-05 Tehran University of Medical Sciences Impact of letrozol on oocyte quality and IVF success Impact of letrozol on improvement oocyte quality and IVF outcome in infertile patients underwent controlled ovarian stimulation 2020-04-04 anticipated 220 Complete https://irct.ir/trial/46787 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Block Randomization In this study all of participation, consist of 220 individuals , dividing to 55 blocks with 4 persons . In each block, equal number of intervention and control groups exist. These 55 blocks , are in 55 different arrangements of intervention and control groups, Blinding description: Participants after signed informed constant , randomly assigned to either study groups and received drug or placebo which is thoroughly identical and same package. patients are blind to which groups that belong to. Researcher is blind by preparing and packing of drugs and placebo and ascertaining control or intervention groups is done by someone outside the study. Study outcomes partly is done by researcher who blind to study groups and other part by embryologist who is blind to study groups. All data will deliver to statistics by researcher who blind to study groups. N/A Condition 1: Infertility. Condition 2: Infertility. Condition 3: Infertility. Condition 4: Infertility. Condition 5: Infertility. Condition 6: Infertility. Intervention 1: Intervention group: Simultaneous with introduce stimulation ovulation drugs , tablet letrozol 2.5 milligram (Iran hormone company )two time a day until trigger day will receive. Intervention 2: Control group: This group simultaneous with introduce ovulation stimulation drugs , received two tablets of letrozol placebo (Iran hormone company ) a day until trigger day. 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 I think that if editor of published article or reviewer of article demand patient data, i permit do it after patient constant
public Mahin Bandarian
Vali - e - Asr hospital, Eastern bagherkhan Ave , Chamran High way, Tohid Square
Tehran Iran (Islamic Republic of) 1419733141 +98 21 6693 9320 mahbandarianmd@ yahoo.com Tehran University of Medical Sciences scientific Mahin Bandarian
Vali -e-Asr hospital, Eastern bagherkhan Ave, Chamran Highway , Tohid Square
Tehran Iran (Islamic Republic of) 1419733141 +98 21 6693 9320 mahbandarianmd@yahoo.com Tehran University of Medical Sciences Iran (Islamic Republic of) Infertile patient that IVF candidate with 40 years old or less use of antagonist protocol for IVF 17 years 40 years Female Patient with cancer Use of IVF protocol except antagonist protocol N97.0 N97.1 N97.2 N97.8 N97.9 Z31.81 Female infertility associated with anovulation Female infertility of tubal origin Female infertility of uterine origin Female infertility of other origin Female infertility, unspecified Encounter for male factor infertility in female patient Treatment - Drugs Placebo Intervention group: Simultaneous with introduce stimulation ovulation drugs , tablet letrozol 2.5 milligram (Iran hormone company )two time a day until trigger day will receive. Control group: This group simultaneous with introduce ovulation stimulation drugs , received two tablets of letrozol placebo (Iran hormone company ) a day until trigger day Number of metaphase 2 oocyte. Timepoint: After ovum pick up. Method of measurement: Number of metaphase 2 by counting metaphase 2 oocyte by embryologist. Oocyte quality. Timepoint: After ovum pick up. Method of measurement: Based on morphology of different parts of metaphase 2 oocyte which determined by embryologist. Oocyte maturation rate. Timepoint: After ovum pickup. Method of measurement: Number of metaphase2 oocytes divided to number of picked up oocytes. Fertilization rate. Timepoint: After injection of sperm to metaphase 2 oocyte. Method of measurement: Number of 2PN divided to number of metaphase 2 oocyte that injected. Clinical pregnancy rate. Timepoint: After embryo transfer. Method of measurement: Number of pregnancy that confirmed with presence of gestational sac in ultrasonography divided to number of fresh or frozen embryo transfer cycles. Tehran University of Medical Sciences Approved 2020-03-14 Ethics Committee in the research of Imam Khomeini Hospital Complex, Tehran University of Medical Sci End of Keshavarz Blvd., Dr. Gharib St., Imam Khomeini Hospital Complex Tehran Tehran Iran (Islamic Republic of)