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IRCT2016071628950N1 IRCT 2016-10-20 Vice chancellor for research, Shahid Sadoughi University of Medical Sciences Effect of treatment protocol on pregnancy outcome in infertile poor ovarian responder women undergoing in vitro fertilization/ intra cytoplasmic sperm injection (IVF/ ICSI) Clinical trail of comparison of pregnancy outcome in delay gonadotropin releasing hormone(GnRH) antagonist versus microdose flare GnRH agonist protocol in infertile poor ovarian responder women undergoing in vitro fertilization/ intra cytoplasmic sperm injection (IVF/ ICSI) cycles 2016-09-22 anticipated 100 Complete https://irct.ir/trial/23376 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Other design features: Randomized allocation with computerized program we divide the patients randomly in intervention and control groups with table of random numbers. 3 Female infertility. Intervention 1: In interventional group delay Gn RH antagonist protocol for controlled ovarian hyper stimulation is used. All patients are received estrogen tablet 2 milligram daily starting in mid luteal previous cycle (21 cycle) for 10 days. Cetrotide (Cetrorelix, Switzerland) 0.25 sub cutaneous daily is administered after cessation of estradiol. Cetrotide is continued for 7 days and ovarian stimulation is started after 7 days of GnRH antagonist pretreatment with 300 unit gonadotropin(Gonal f, Sorono, Switzerland).The women are controlled with serial sonography after five day ovarian stimulation. When a lead follicle reaches 12 millimeter, Cetrotide is initiated again and is continued until the human chorionic gonadotropin ( HCG, Pregnyle,Netherlands ) trigger. Final oocyte maturation is triggered in both groups with 10,000 unit HCG when the largest two follicles attain a mean diameter of 17 millimeter. Oocyte retrieval is performed under transvaginal ultrasound guidance 36 hours after hCG administration. Intervention 2: In control group, microdose flare Gn RH agonist protocol for controlled ovarian hyperstimulation is used.On the second day of menstrual cycle Buserlin acetate (Cinnafact, Cinnagen) 50 micro gram twice daily sub cutaneous is initiated which continued until trigger day. After 2 days, stimulation with a gonadotropin (Gonal f, Sorono,Switzerland) 300 unit daily is begun. The women are controlled with serial sonography since 9th day of cycle.The dose and follow up are individualized according to the ovarian response. Final oocyte maturation is triggered with 10,000 unit human chorionic gonadotropin (HCG,Pregnyle, Netherlands) when the largest two follicles attain a mean diameter of 17 millimeter. Oocyte retrieval is performed under transvaginal ultrasound guidance 36 hours after hCG administration.
public DR Nosrat Neghab
Bouali Avenue, Safayeh, Yazd, Iran
Yazd Iran (Islamic Republic of) 8916877391 +98 35 3824 7085 nosrat20@yahoo.com; nosratneghab@ssu.ac.ir Yazd Research and Clinical Center for Infertility Shahid Sadoughi University of Medical Sciences scientific DR Robab Davar
Bouali Avenue, Safayeh, Yazd, Iran
Yazd Iran (Islamic Republic of) 8916877391 +98 35 3824 7085 davar@ssu.ac.ir Yazd Research and Clinical Center for Infertility Shahid Sadoughi University of Medical Sciences Iran (Islamic Republic of) Inclusion criteria: infertile women between 18 to 42 years old with ≤8 antral follicle count in bilateral ovaries; and or patients with basal follicle stimulating hormone (FSH) ≥ 9 milli unit per milliliter; and or patients with a history of cancelled invitro fertilization(IVF) cycle ≤3 dominant follicles; and or ≤500 pico mole per liter estradiol (E2) levels at human chorionic gonadotropin( hCG) administration day. Exclusion criteria: patients under 18 years old or over 42 years old; patients with sever male factor 18 years 42 years Female N97.9 Female infertility ,unspecified Treatment - Drugs Treatment - Drugs In interventional group delay Gn RH antagonist protocol for controlled ovarian hyper stimulation is used. All patients are received estrogen tablet 2 milligram daily starting in mid luteal previous cycle (21 cycle) for 10 days. Cetrotide (Cetrorelix, Switzerland) 0.25 sub cutaneous daily is administered after cessation of estradiol. Cetrotide is continued for 7 days and ovarian stimulation is started after 7 days of GnRH antagonist pretreatment with 300 unit gonadotropin(Gonal f, Sorono, Switzerland).The women are controlled with serial sonography after five day ovarian stimulation. When a lead follicle reaches 12 millimeter, Cetrotide is initiated again and is continued until the human chorionic gonadotropin ( HCG, Pregnyle,Netherlands ) trigger. Final oocyte maturation is triggered in both groups with 10,000 unit HCG when the largest two follicles attain a mean diameter of 17 millimeter. Oocyte retrieval is performed under transvaginal ultrasound guidance 36 hours after hCG administration In control group, microdose flare Gn RH agonist protocol for controlled ovarian hyperstimulation is used.On the second day of menstrual cycle Buserlin acetate (Cinnafact, Cinnagen) 50 micro gram twice daily sub cutaneous is initiated which continued until trigger day. After 2 days, stimulation with a gonadotropin (Gonal f, Sorono,Switzerland) 300 unit daily is begun. The women are controlled with serial sonography since 9th day of cycle.The dose and follow up are individualized according to the ovarian response. Final oocyte maturation is triggered with 10,000 unit human chorionic gonadotropin (HCG,Pregnyle, Netherlands) when the largest two follicles attain a mean diameter of 17 millimeter. Oocyte retrieval is performed under transvaginal ultrasound guidance 36 hours after hCG administration. Clinical pregnancy. Timepoint: 28 days after transfer. Method of measurement: Vaginal sonography. Number of mature oocytes. Timepoint: Oocyte pucture day. Method of measurement: Number of M2 oocytes. Vice chancellor for research, Shahid Sadoughi University of Medical Sciences Approved 2016-06-12 Ethics committee of Shahid Sadoughi University of Medical Sciences Bouali Avenue, Safayeh, Yazd, Iran Yazd Iran (Islamic Republic of)