]>
IRCT20110731007165N9 IRCT 2020-02-08 Tehran University of Medical Sciences Early initiation of GnRH Antagonist in Poor responder Patients Comparison of the Effect of the early initiation of GnRH Antagonist in the Early Follicular Phase in Poor Responder Patients 2019-10-06 anticipated 116 Complete https://irct.ir/trial/45024 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: The randomization list will be prepared by the statistician. Treatments will be placed in sealed envelopes and will be kept by the out-of-study nurse. After identification of the eligibility of the patient, the procedure will be explained to her and informed consent will be obtained, Blinding description: Completion of the final information is up to the person who is unaware of the type of treatment and also the specialist will be blind. 3 Poor Ovarian Response. Intervention 1: Intervention group: Early antagonist protocol: Recombinant FSH (150-225 IU) and GnRH Antagonist (Cetrotid 0.25 mg) will be started simultaneously on the second day of the cycle. Final oocyte maturation will be triggered with 5000 units of HCG when at least one 18-mm and two 16-mm follicles were detected on ultrasound. The ovarian puncture will be performed 36 hours after HCG injection. One or two embryos will be transferred three days after the ovarian puncture. The luteal phase support will be performed by the use of 100 mg of Progesterone. Intervention 2: Control group: Conventional antagonist protocol: Recombinant FSH (150-225 IU) will be started on day 2 of the cycle and the Antagonist (Cetrotid 0.25 mg) will be injected when follicle size reaches to 13-14 mmHg. Final oocyte maturation will be triggered with 5000 units of HCG when at least one 18-mm and two 16-mm follicles were detected on ultrasound. The ovarian puncture will be performed 36 hours after HCG injection. One or two embryos will be transferred three days after the ovarian puncture. The luteal phase support will be performed by the use of 100 mg of Progesterone. 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 The research team have not yet decided how the data will be released.
public Dr. Tayebeh Esfidani
No. 162 َAlley (Abdul Majid), Shahid Baghdarnia Street (North Rashid), Shahid Bagheri Highway, Resalat Highway, Tehran, Iran
Tehran Iran (Islamic Republic of) 1653915981 +98 21 7788 3195 esfidani.tayebeh@gmail.com Tehran University of Medical Sciences scientific Dr. Ladan Kashani
No. 162 َAlley (Abdul Majid), Shahid Baghdarnia Street (North Rashid), Shahid Bagheri Highway, Resalat Highway, Tehran, Iran
Tehran Iran (Islamic Republic of) 1653915981 +98 21 7788 3195 Kashani_ladan@tums.ac.ir Tehran University of Medical Sciences Iran (Islamic Republic of) Age between 18 up to 44 years History of poor ovarian response (POR) in previous cycle (oocyte less than 3 in a conventional protocol) Antral follicle count (AFC) less than 5-7 or Anti-Müllerian hormone (AMH) <0.5-1.1 Poor ovarian response after maximal stimulation 18 years 44 years Female Polycystic Ovarian Syndrome Hypothalamic amenorrhea Uterine congenital anomalies and uterine cavity abnormalities (Bicorn uterus, Unicorn uterus, Asherman, Liomyuma, Polyp, etc.) Repeated IVF failure (more than three consecutive failures) N98 Complications associated with artificial fertilization Treatment - Drugs Treatment - Drugs Intervention group: Early antagonist protocol: Recombinant FSH (150-225 IU) and GnRH Antagonist (Cetrotid 0.25 mg) will be started simultaneously on the second day of the cycle. Final oocyte maturation will be triggered with 5000 units of HCG when at least one 18-mm and two 16-mm follicles were detected on ultrasound. The ovarian puncture will be performed 36 hours after HCG injection. One or two embryos will be transferred three days after the ovarian puncture. The luteal phase support will be performed by the use of 100 mg of Progesterone. Control group: Conventional antagonist protocol: Recombinant FSH (150-225 IU) will be started on day 2 of the cycle and the Antagonist (Cetrotid 0.25 mg) will be injected when follicle size reaches to 13-14 mmHg. Final oocyte maturation will be triggered with 5000 units of HCG when at least one 18-mm and two 16-mm follicles were detected on ultrasound. The ovarian puncture will be performed 36 hours after HCG injection. One or two embryos will be transferred three days after the ovarian puncture. The luteal phase support will be performed by the use of 100 mg of Progesterone. Number of Mature Retrieved Oocytes. Timepoint: At the end of the study. Method of measurement: Embryology Report. Embryos. Timepoint: At the end of the study. Method of measurement: Embryology Report. Total Gonadotropins used. Timepoint: At the end of the study. Method of measurement: Checklist. Total Antagonist used. Timepoint: At the end of the study. Method of measurement: Checklist. Total Days of Induction of ovulation. Timepoint: At the end of the study. Method of measurement: Checklist. Total Number of Retrieved Oocytes. Timepoint: At the end of the study. Method of measurement: Embryology Report. Clinical Pregnancy. Timepoint: At the end of the study. Method of measurement: Pregnancy confirmed by both high levels of hCG and presence of gestational sac with positive heart beats in ultrasound. Ongoing pregnancy. Timepoint: At the end of the study. Method of measurement: Pregnancy had continued more than 12 weeks of gestation. Chemical Pregnancy. Timepoint: At the end of the study. Method of measurement: A very early pregnancy loss in the first few weeks. Luteinizing Hormone (LH) Level. Timepoint: In the second day of the cycle and then one time in trigger day. Method of measurement: Blood Test. Progestrone Level. Timepoint: In the second day of the cycle and then one time in trigger day. Method of measurement: Blood Test. Estradiol Level. Timepoint: In the second day of the cycle and then one time in trigger day. Method of measurement: Blood Test. Implantation Rate. Timepoint: At the end of the study. Method of measurement: The percentage of embryos which successfully undergo implantation compared to the number of embryos transferred in a given period. Fertilization rate. Timepoint: At the end of the study. Method of measurement: Percentage of transformation of micro injected oocytes into two pronuclei. Tehran University of Medical Sciences Approved 2019-10-05 Ethics Committee of Tehran University of Medical Sciences Qods St, Keshavarz Blvd, Tehran, Iran Tehran Tehran Iran (Islamic Republic of)