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IRCT2014111213421N2 IRCT 2015-01-10 Urmia University of Medical Sciences Prednisolone on pregnancy outcomes prednizolone and microinjection Effects of Prednisolone on pregnancy outcomes among infertile patients undergoing ‎‎Intra Cytoplasmic Sperm Injection (ICSI)‎ 2010-03-21 anticipated 248 Complete https://irct.ir/trial/13277 interventional Randomization: Not randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Other design features: -. N/A infertility. Intervention 1: Control group: Patients who candidate for microinjection (ICSI), underwent for induction of ovulation, underwent by long protocol in the beginning of cycle. Determination of uterus depth was done for all patients. For all of patients were given 100 mg/12 hrs Doxycycline for 10 days and 1 mg daily Folic acid from the previous cycle, Contraceptive pills daily started on the second day of their menses and continued for 21 day. 50 line of insulin syringe Superfact (Buserelin) was injected sc. 6 days before menstruation. After end of 21 contraception pill consumption, on the second day of menstral cycle the injected dose of Superfact GnRH Antagonist (Buserelin) was reduced to half. First, we started gonadotropin (Gonal.F) S.C from second days, after 1 week , Gonal.F and menogone to given suitable follicles. Dose of gonadotropin was determined base on age, FSH level , amount of antral folicule and history of IVF. The size of the follicles and endometrial thickness was monitored by transvaginal sonography. Once at least 3 follicles reached the size of 18 mm, 10000 units hCG (FERRING-Germany) was injected to the patient. Ovum pick up was done 34 hours after the injection by transvaginal sonography under spinal or light general anesthesia were extracted. After 72 hours ,embryos were transferred in distance 1cm up to foundus of uterus. Same sequential media (GII series, VitrolifeTM ; Colorado, USA) was used for all embryo culturing. Embryo scoring was done according to zonal thickness, cytoplasm fragmentation, blastomeres number, and morphology. The clinician also made sure that the endometrium has three lines and its thickness is 8-10 mm. for luteal phase support 100 mg progesterone IM daily were given from ovum pick up day , detecting receiving positive β HCG results and detecting of fetal heart by sonography , respectively to 11 weeks of pregnancy. Intervention 2: Intervention Group also followed the same procedure as control groups and the same medications were used. In addition, 20 mg daily prednisolone was given to all Intervention Group, One day before the emberyo transfer, 20 mg daily prednisolone were used for one week. Prednisolone’s dose reduced to 10 mg daily for the second week and 5 mg daily in the last 2 days and then was stopped. One tablet Ranitidine also was used to prevent any possible stomach and intestinal discomfort in the morning.
public Fariba Nanbakhsh
Urmia ,Kashani Street , Health Center No 6,Room NO 42
Urmia Iran (Islamic Republic of) 0443445138 +98 44 3344 5138 - Reproductive Health Research Center scientific Fariba Nanbakhsh
Urmia,Kashani Street,Motahri Hospital
Urmia Iran (Islamic Republic of) 04433445138 +98 44 3344 5138 f.nanbakhsh@umsu.ac.ir Reproductive Health Research Center Iran (Islamic Republic of) i nclusion criteria: having infertility;FSH serum levels lower than 10 ,age of lower than 42 years exclusion criteria: having asthma; systemic disorders; gastrointestinal disorders no limit no limit Female N97.9 Female infertility, unspecified Treatment - Drugs Treatment - Drugs Control group: Patients who candidate for microinjection (ICSI), underwent for induction of ovulation, underwent by long protocol in the beginning of cycle. Determination of uterus depth was done for all patients. For all of patients were given 100 mg/12 hrs Doxycycline for 10 days and 1 mg daily Folic acid from the previous cycle, Contraceptive pills daily started on the second day of their menses and continued for 21 day. 50 line of insulin syringe Superfact (Buserelin) was injected sc. 6 days before menstruation. After end of 21 contraception pill consumption, on the second day of menstral cycle the injected dose of Superfact GnRH Antagonist (Buserelin) was reduced to half. First, we started gonadotropin (Gonal.F) S.C from second days, after 1 week , Gonal.F and menogone to given suitable follicles. Dose of gonadotropin was determined base on age, FSH level , amount of antral folicule and history of IVF. The size of the follicles and endometrial thickness was monitored by transvaginal sonography. Once at least 3 follicles reached the size of 18 mm, 10000 units hCG (FERRING-Germany) was injected to the patient. Ovum pick up was done 34 hours after the injection by transvaginal sonography under spinal or light general anesthesia were extracted. After 72 hours ,embryos were transferred in distance 1cm up to foundus of uterus. Same sequential media (GII series, VitrolifeTM ; Colorado, USA) was used for all embryo culturing. Embryo scoring was done according to zonal thickness, cytoplasm fragmentation, blastomeres number, and morphology. The clinician also made sure that the endometrium has three lines and its thickness is 8-10 mm. for luteal phase support 100 mg progesterone IM daily were given from ovum pick up day , detecting receiving positive β HCG results and detecting of fetal heart by sonography , respectively to 11 weeks of pregnancy. Intervention Group also followed the same procedure as control groups and the same medications were used. In addition, 20 mg daily prednisolone was given to all Intervention Group, One day before the emberyo transfer, 20 mg daily prednisolone were used for one week. Prednisolone’s dose reduced to 10 mg daily for the second week and 5 mg daily in the last 2 days and then was stopped. One tablet Ranitidine also was used to prevent any possible stomach and intestinal discomfort in the morning. Abortion. Timepoint: until 20 weeks. Method of measurement: observation. Intra uterus pregnancy. Timepoint: 12,20 weeks. Method of measurement: sonography. Chemical pregnancy. Timepoint: 6 weeks. Method of measurement: BHCG mesuring. None. Timepoint: none. Method of measurement: none. Urmia University of Medical Sciences Approved 2010-09-23 Urmia University of Medical Sciences Urmia, Urmia University of Medical Sciences Urmia Iran (Islamic Republic of)