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IRCT2014101919578N1 IRCT 2015-02-06 Tehran University of Medical Sciences To Assess Effects Of Letrozole In Infertility Treatment To Evaluate Effects of Adding Letrozole To GnRh Antagonist In Pregnancy Outcome of Poor Ovarian Responders Candidate For InVitro Fertillization or IntraCytoplasmic Sperm Injection And Comparing It With Pregnancy Outcome of Poor Ovarian Responders Treated By GnRh Antsgonist Alone 2013-06-18 anticipated 70 Complete https://irct.ir/trial/17493 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Other, Purpose: Treatment. N/A poor ovarian response. Intervention 1: In control group ovarian stimulation will be done by using 225 IU Follicle_Stimulating Hormone(Gonal-F,MERC, italy) and 150 IU human Menopausal Gonadotropine(Pergonal, Serono, Swithszerland) started at third day of mensturation. Serial transvaginal sonography and serum estradiol measuement are done to assess ovarian response and adjust gonadotropin dose per patient. Certolix(Certotide, Serono, swithszerland) 0.25 miligrams daily subcutaneously will be added when at least there is a 14 mm follicle. When at least two 17 mm follicles are developed 10000 IU human Chrionic Gonadotropin(Pregnyl, Organon, Netherland) is injected trasmuscularly. Oovocytes are punctured 35 to 36 hours later and then fertilization will ocurred via invitro Fertillization or IntraCytoplasmic Sperm Injection and then embrios of best quality will be transferred into uterine on third day of their developement. Finally pregnancy outcome will be compared between two groups. Intervention 2: In intervention group ovarian stimulation will be done by using 225 IU Follicle_Stimulating Hormone(Gonal-F, MERC, italy) and 150 IU human Menopausal Gonadotropine(Pergonal, Serono, Swithszerland) started at third day of mensturation. In this group Letrozole 2.5 mg/d(Letrozole, AbuReyhan, Iran) is added from menstural days 3rd to 7th too. Serial transvaginal sonography and serum estradiol measuement are done to assess ovarian response and adjust gonadotropin dose per patient.certolix(Certotide, Serono, swithszerland) 0.25 miligrams daily subcutaneously will be added when at least there is a 14 mm follicle. When at least two 17 mm follicles are developed 10000 IU human Chrionic Gonadotropin(Pregnyl, Organon, Netherland) is injected trasmuscularly. Oovocytes are punctured 35 to 36 hours later and then fertilization will ocurred via invitro Fertillization or IntraCytoplasmic Sperm Injection and then embrios of best quality will be transferred into uterine on third day of developement. Finally pregnancy outcome will be compared between two groups.
public Seyyede Mojgan Ghalandarpoorattar
Jaame_Zanan Hospital, Northern Ostad Nejatollahi Street, Tehran, Iran.
Tehran Iran (Islamic Republic of) +98 21 8890 0002 medicalstudent81@yahoo.com Jaame_Zanan Hospital scientific Firuzeh Akbariasbagh
Jaame_Zanan Hospital, Northern Ostad Nejatollahi Avenue, Tehran, Iran.
Tehran Iran (Islamic Republic of) +98 21 8890 0002 fasbagh_MD@yahoo.com Jaame_Zanan Hospital Iran (Islamic Republic of) Inclusion Criteria: Infertile female who are reffered to InVitro Fertillization Department of Jaame_Zanan Hospital candidates for InVitro fertillization or IntraCytoplasmic Sperm Injection; females aged over 30 years old; females diagnosed as poor ovarian responders. Females should have at least one of listing criterias to be classified as poor responders: previous cancled cycle due to poor ovarian response in an InVitro fertillization or IntraCytoplasmic Sperm Injection cycle (defined as having 3 or less oovocytes retrieved or serum estradiol less than 500 pg/ml), serum Follicle_Stimulating Hormone over 10 U/ml and age above 40 years old. Exclusion criterias are: Infertile females having all inclusion criterias but do not wish to be included in the project; females who show letrozole hypersensivity reactions or serious intolerable side effects of letrozole; females over 50 years old; having endocrine disorders such as thyroid dysfunction, hyperprolactinemia or diabetes;previous ovarian surgery; having a follicle larger than 10 mm at third day of menstural cycle; history of OHSS in previous ART cycle; uncorrected Mullerian anomaly; active renal or hepatic diseases. 30 years 50 years Female N00_N99 R00_R99 Treatment - Drugs Treatment - Drugs In control group ovarian stimulation will be done by using 225 IU Follicle_Stimulating Hormone(Gonal-F,MERC, italy) and 150 IU human Menopausal Gonadotropine(Pergonal, Serono, Swithszerland) started at third day of mensturation. Serial transvaginal sonography and serum estradiol measuement are done to assess ovarian response and adjust gonadotropin dose per patient. Certolix(Certotide, Serono, swithszerland) 0.25 miligrams daily subcutaneously will be added when at least there is a 14 mm follicle. When at least two 17 mm follicles are developed 10000 IU human Chrionic Gonadotropin(Pregnyl, Organon, Netherland) is injected trasmuscularly. Oovocytes are punctured 35 to 36 hours later and then fertilization will ocurred via invitro Fertillization or IntraCytoplasmic Sperm Injection and then embrios of best quality will be transferred into uterine on third day of their developement. Finally pregnancy outcome will be compared between two groups. In intervention group ovarian stimulation will be done by using 225 IU Follicle_Stimulating Hormone(Gonal-F, MERC, italy) and 150 IU human Menopausal Gonadotropine(Pergonal, Serono, Swithszerland) started at third day of mensturation. In this group Letrozole 2.5 mg/d(Letrozole, AbuReyhan, Iran) is added from menstural days 3rd to 7th too. Serial transvaginal sonography and serum estradiol measuement are done to assess ovarian response and adjust gonadotropin dose per patient.certolix(Certotide, Serono, swithszerland) 0.25 miligrams daily subcutaneously will be added when at least there is a 14 mm follicle. When at least two 17 mm follicles are developed 10000 IU human Chrionic Gonadotropin(Pregnyl, Organon, Netherland) is injected trasmuscularly. Oovocytes are punctured 35 to 36 hours later and then fertilization will ocurred via invitro Fertillization or IntraCytoplasmic Sperm Injection and then embrios of best quality will be transferred into uterine on third day of developement. Finally pregnancy outcome will be compared between two groups. Oocytes retrieved number. Timepoint: at the end of ovarian stimulation cycle. Method of measurement: oovocyte retrieved containing both metaphase1 and 2 counted under microscopic examination by genetician. Embrios transferred. Timepoint: at the end of cycle after 3-day growth of invitro. Method of measurement: counting embrios under microscopic examination by genetician. Endometrial thickness. Timepoint: on the day of hCG administration. Method of measurement: measured by transvaginal sonograghy by gynecologist. Total gonadotropin dose. Timepoint: after oovocyte puncture. Method of measurement: number of 75 IU gonadotropin ampules used till oovocyte puncture. Clinical pregnancy rate per cycle. Timepoint: at the end of project. Method of measurement: SPSS softeware. Clinical pregnancy rate per emberio transfer. Timepoint: at the end of project. Method of measurement: SPSS softeware. Implantation rate per cycle. Timepoint: at the end of project. Method of measurement: SPSS softeware. Implantation rate per emberio transfer. Timepoint: at the end of project. Method of measurement: SPSS softeware. Cancelation rate per cycle. Timepoint: at the end of project. Method of measurement: SPSS softeware. Tehran University of Medical Sciences Approved 2013-06-15 Ethics Committee of Tehran Universiy of Medical Sciences Medical Ethics and History of medicine Research Center building, fourth floor, no.21, 16 Azar street, Keshavarz Boulevar,Tehran, Iran. Tehran Iran (Islamic Republic of)