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IRCT20180425039418N9 IRCT 2019-11-09 Vice-chancellor for research, Zahedan University of Medical Sciences The effect of intrauterine injection of plasma concentrated platelet on pregnancy rate Evaluation of intrauterine Platelet Rich Plasma injection on pregnancy rate in women with implantation failure In Vitro Fertilization fertilization cycle 2019-03-21 anticipated 90 Complete https://irct.ir/trial/43213 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Convenient sampling method will be used and blocked randomization (using a random number table) will be used for patient allocation to group. N/A implantation failure. Intervention 1: Intervention group: All patients will receive 6 mg/d Estradiol valerate from the second day of the menstrual cycle until the endometrial thickness reaches 8 mm. When the endometrial thickness reached 8 mm, 400 mg progesterone vaginal suppository BD will be initiated. Three days later, 2-3 high quality (grade A or B) 8-cell embryos (day 3) will be transferred. In the case group, intrauterine infusion of concentrated platelet will be performed 48 hours before embryo transfer. Concentrated platelet-derived from autologous blood will be centrifuged in two steps. Estradiol valerate and progesterone suppository will be continued after embryo transfer for two weeks. In the case of any kind of pregnancy and positive B-hCG, hormone replacement therapy will be continued until 12 weeks of pregnancy. All embryos will be transferred by infertility fellowship under the sonography guide. Two embryos will be transferred for patients under 35 and three embryos for patients above 35. On the day of consecrated platelet infusion, 17.5 ml of venous blood will be taken in a syringe containing 2.5 ml of citric acid (anti-coagulation solution) which will be immediately centrifuged at 1200 rpm for 12 minutes to separate blood cells. Then, plasma is centrifuged at 3300 rpm for 7 minutes to achieve concentrated platelet which contains 4-5 times more platelet compared with venous blood. 0.5 ml of the concentrated platelet will be infused to the interior of the uterus wall using an IUI catheter (Takvin, made in Iran). The period before infusion will be considered as the control for each case. Chemical and clinical pregnancy are respectively defined as a positive serum level of B-hCG two weeks after embryo transfer, and fetal heartbeat in transvaginal sonography five weeks after embryo transfer. Intervention 2: Control group: All patients will receive 6 mg/d Estradiol valerate from the second day of the menstrual cycle until the endometrial thickness reaches 8 mm. When the endometrial thickness reached 8 mm, 400 mg progesterone vaginal suppository BD will be initiated. Three days later, 2-3 high quality (grade A or B) 8-cell embryos (day 3) will be transferred. Estradiol valerate and progesterone suppository will be continued after embryo transfer for two weeks. In the case of any kind of pregnancy and positive B-hCG, hormone replacement therapy will be continued until 12 weeks of pregnancy. All embryos will be transferred by infertility fellowship under the sonography guide. Two embryos will be transferred for patients under 35 and three embryos for patients above 35. Chemical and clinical pregnancy are respectively defined as a positive serum level of B-hCG two weeks after embryo transfer, and fetal heartbeat in trans-vaginal sonography five weeks after embryo transfer. 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 No more information
public Sara Ershadi
Dr.Hesabi Square , campus of medical sciences
Zahedan Iran (Islamic Republic of) 98167-43175 +98 54 3329 5620 sara_e1990@yahoo.com Zahedan University of Medical Sciences scientific Dr Marzieh Ghasemi
Dr. Hesabi square campus of medical sciences
Zahedan Iran (Islamic Republic of) 98167-43175 +98 543329571522 public@zaums.ac.ir Zahedan University of Medical Sciences Iran (Islamic Republic of) Not the Underlying Disease being at the Age of 20 to 40 2 or 3 times implantation failure history 20 years 40 years Female Specific drug use Low quality embryos Endometrial growth not more than 8 mm N97.9 Female infertility, unspecified Treatment - Other Treatment - Other Intervention group: All patients will receive 6 mg/d Estradiol valerate from the second day of the menstrual cycle until the endometrial thickness reaches 8 mm. When the endometrial thickness reached 8 mm, 400 mg progesterone vaginal suppository BD will be initiated. Three days later, 2-3 high quality (grade A or B) 8-cell embryos (day 3) will be transferred. In the case group, intrauterine infusion of concentrated platelet will be performed 48 hours before embryo transfer. Concentrated platelet-derived from autologous blood will be centrifuged in two steps. Estradiol valerate and progesterone suppository will be continued after embryo transfer for two weeks. In the case of any kind of pregnancy and positive B-hCG, hormone replacement therapy will be continued until 12 weeks of pregnancy. All embryos will be transferred by infertility fellowship under the sonography guide. Two embryos will be transferred for patients under 35 and three embryos for patients above 35. On the day of consecrated platelet infusion, 17.5 ml of venous blood will be taken in a syringe containing 2.5 ml of citric acid (anti-coagulation solution) which will be immediately centrifuged at 1200 rpm for 12 minutes to separate blood cells. Then, plasma is centrifuged at 3300 rpm for 7 minutes to achieve concentrated platelet which contains 4-5 times more platelet compared with venous blood. 0.5 ml of the concentrated platelet will be infused to the interior of the uterus wall using an IUI catheter (Takvin, made in Iran). The period before infusion will be considered as the control for each case. Chemical and clinical pregnancy are respectively defined as a positive serum level of B-hCG two weeks after embryo transfer, and fetal heartbeat in transvaginal sonography five weeks after embryo transfer. Control group: All patients will receive 6 mg/d Estradiol valerate from the second day of the menstrual cycle until the endometrial thickness reaches 8 mm. When the endometrial thickness reached 8 mm, 400 mg progesterone vaginal suppository BD will be initiated. Three days later, 2-3 high quality (grade A or B) 8-cell embryos (day 3) will be transferred. Estradiol valerate and progesterone suppository will be continued after embryo transfer for two weeks. In the case of any kind of pregnancy and positive B-hCG, hormone replacement therapy will be continued until 12 weeks of pregnancy. All embryos will be transferred by infertility fellowship under the sonography guide. Two embryos will be transferred for patients under 35 and three embryos for patients above 35. Chemical and clinical pregnancy are respectively defined as a positive serum level of B-hCG two weeks after embryo transfer, and fetal heartbeat in trans-vaginal sonography five weeks after embryo transfer. The number of pregnancies. Timepoint: Chemical and clinical pregnancy are respectively defined as positive serum level of B-hCG two weeks after embryo transfer, and fetal heart beat in trans-vaginal sonography five weeks after embryo transfer. Method of measurement: The structured checklist. Vice-chancellor for research, Zahedan University of Medical Sciences Approved 2019-03-10 Ethics committee of Zahedan University of Medical Sciences Dr.Hesabi Square, Campus of Medical Scineces Zahedan Sistan-va-Balouchestan Iran (Islamic Republic of)