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IRCT201105096420N1 IRCT 2011-06-06 Yazd Research and Clinical Center for Infertility Comparison of two treatment protocol in assisted reproductive techniques (ART) poor responders Comparison between ultrashort gonadotropin-releasing hormone agonist and flare microdose protocol in ART poor responders 2007-06-21 anticipated 120 Complete https://irct.ir/trial/6860 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment. 2-3 Infertility. Intervention 1: In group I, 0.05mg subcutaneous Buserelin (suprefact, serono) was injected two times per day from the day 1 of cycle and HMG (Menogon, Ferring) 300 IU per day intramuscular from day 3 of cycle. Follicular monitoring was started from day 9 of cycle by serial vaginal ultrasonography and then gonadotropin doses adjustment was done as required. hCG (pregnyl; NV organon, oss, Netherlands) 10000 IU was injectod Intramuscular when at least 2 follicles ≥ 18mm were noted on ultrasonography. Oocyte retrieval was scheduled 36 hours after hCG injection and conventional IVF or intracytoplasmic sperm injection (ICSI) was performed. Embryo transfer was done 48-72 hours after oocyte retrieval. The luteal phase support was initiated from the day of oocyte retrieval with 100 mg Progesterone in oil (Progesterone, Abureihan co., Tehran, Iran) per day. Intervention 2: In group II, ovulation induction was performed with Buserelin (suprefact, serono) 0.5mg SC per day started on day 1 of cycle and continued for 3 consecutive days . HMG (menogon, ferring) 300 IU per day was started on day 3 of cycle. GnRH antagonist (cetrorelix, serono laboratories, Aubonne, Switzerland) 0.25mg sc per day was started when the follicle’s size reach to 14mm. Follicular monitoring started from day 9 of cycle and hCG (pregnyle, NV orgaron, oss, Nether lands) 10000 IU was injected if at least 2 follicles ≥ 17-18mm were noted on ultrasonography and Oocyte retrieval was scheduled 36 hours after hCG injection. Other steps was done like group I. In both groups, Serum B-hCG was measured after 14 days of embryo transfer. If B-hCG was Possitive, the clinical pregnancy was confirmed by observation of the fetal heart activity using a transvaginal ultrasonography 4-5 weeks after oocyte retrieval. And thenو the two groups were compared in number of follicles, serum estradiol levels, endometrial thickness, Number and quality of oocytes, number and quality embryo, implantation rate and clinical and chemistry pregnancy rate.
public Dr. Maryam Eftekhar
yazd Research and Clinical Center for Infertility, Bouali Ave, Safayeh
Yazd Iran (Islamic Republic of) 8916877391 +98 35 1824 7348 eftekhar@ssu.ac.ir , pkhani55@gmail.com Research and Clinical Center for Infertility scientific Dr. Maryam Eftekhar
Research and Clinical Center for Infertility, Bouali Ave, Safayeh
Yazd Iran (Islamic Republic of) 8916877391 +98 35 1824 8348 eftekhar@ssu.ac.ir , pkhani55@gmail.com Research and Clinical Center for Infertility, Shahid Sadoughi University of Medical Sciences Iran (Islamic Republic of) Inclusion criteria: A history of one or more failed in IVF cycles which three or fewer oocytes were been retrieved or their serum steradiol’s level in day of HCG injection was <500 pg/ml or FSH in day 3 of cycle was >10 or age>40 years. Exclusion criteria: Body mass index higher than 30 and endocrine or metabolic disorder, endometriosis and severe male factor (azospermia ). 18 years 45 years Female N97 Female infertility Treatment - Drugs Treatment - Drugs In group I, 0.05mg subcutaneous Buserelin (suprefact, serono) was injected two times per day from the day 1 of cycle and HMG (Menogon, Ferring) 300 IU per day intramuscular from day 3 of cycle. Follicular monitoring was started from day 9 of cycle by serial vaginal ultrasonography and then gonadotropin doses adjustment was done as required. hCG (pregnyl; NV organon, oss, Netherlands) 10000 IU was injectod Intramuscular when at least 2 follicles ≥ 18mm were noted on ultrasonography. Oocyte retrieval was scheduled 36 hours after hCG injection and conventional IVF or intracytoplasmic sperm injection (ICSI) was performed. Embryo transfer was done 48-72 hours after oocyte retrieval. The luteal phase support was initiated from the day of oocyte retrieval with 100 mg Progesterone in oil (Progesterone, Abureihan co., Tehran, Iran) per day. In group II, ovulation induction was performed with Buserelin (suprefact, serono) 0.5mg SC per day started on day 1 of cycle and continued for 3 consecutive days . HMG (menogon, ferring) 300 IU per day was started on day 3 of cycle. GnRH antagonist (cetrorelix, serono laboratories, Aubonne, Switzerland) 0.25mg sc per day was started when the follicle’s size reach to 14mm. Follicular monitoring started from day 9 of cycle and hCG (pregnyle, NV orgaron, oss, Nether lands) 10000 IU was injected if at least 2 follicles ≥ 17-18mm were noted on ultrasonography and Oocyte retrieval was scheduled 36 hours after hCG injection. Other steps was done like group I. In both groups, Serum B-hCG was measured after 14 days of embryo transfer. If B-hCG was Possitive, the clinical pregnancy was confirmed by observation of the fetal heart activity using a transvaginal ultrasonography 4-5 weeks after oocyte retrieval. And thenو the two groups were compared in number of follicles, serum estradiol levels, endometrial thickness, Number and quality of oocytes, number and quality embryo, implantation rate and clinical and chemistry pregnancy rate. Pregnancy. Timepoint: 2 weeks. Method of measurement: BhcG Test. Number of follicles. Timepoint: 15 days. Method of measurement: Numbering. Quality of oocytes. Timepoint: 15 days. Method of measurement: Observation by microscope according to Good –postmature-degenerated. The number of used gonadotropin ampoules. Timepoint: 15 days. Method of measurement: Numbering. Quality of emberyo. Timepoint: 15 days. Method of measurement: According to the symmetrics and exact of Blastomer pieces. Number of oocytes. Timepoint: 15 days. Method of measurement: Numbering. Chemical pregnancy. Timepoint: after 14 days of embryo transfer. Method of measurement: Measurement of serum B-hCG. Clinical pregnancy. Timepoint: 2-3 weeks after positive B-hCG. Method of measurement: observation of the fetal heart activity using a transvaginal ultrasonography. Yazd Research and Clinical Center for Infertility Approved 2009-01-05 Yazd Research and Clinical Center for Infertility Bouali Avenue, Safayeh Yazd Iran (Islamic Republic of)