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IRCT20181030041503N1 IRCT 2019-02-16 Mashhad University of Medical Sciences Clinical pregnancy rate in transfer of fresh embryo , 5 days vs 3 days Clinical trial comparing pregnancy rate in transfer of blastocyst vs cleavage stage in assisted reproductive technology 2018-07-23 anticipated 220 Complete https://irct.ir/trial/35152 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: The random list is using the PASS software.The type of randomization is simple . The analyst and doctor will be unaware of the intervention and control groups, Blinding description: The researcher does not know how to randomize .The Embryologist chooses patients according to random numbers in each group.Patient and evaluator of the results are not known from the assigned group. N/A Transfer of fresh embryo in assisted reproductive technology. Intervention 1: Intervention group:Three ovarian stimulation protocols( long protocol , microdoze and antagonist protocol ) were used to prepare patients for ivf depending on their age and diagnosis. Final oocyte maturation was induced by administration of 10 000 IU hCG when at least three follicles with a diameter of 17 mm were observed during pelvic ultrasound. Oocyte retrieval was performed by vaginal ultrasound-guided puncture 36 h after hCG administration. . Oocytes incubated in IVF medium at 37 °C with 6 %CO2 and 5 % O2 in air with saturated humidity. Finally Oocytes were fertilized by either insemination (IVF) or ICSI. Embryos were cultured in sequential media . The women will be randomly divided into two groups A fresh transfer was performed either on Day 3 or on day 5 after pick up.The luteal phase was supported by utrogestan Vaginal 600 mg daily. Intervention 2: Control group: Three ovarian stimulation protocols( long protocol , microdoze and antagonist protocol ) were used to prepare patients for ivf depending on their age and diagnosis. Final oocyte maturation was induced by administration of 10 000 IU hCG when at least three follicles with a diameter of 17 mm were observed during pelvic ultrasound. Oocyte retrieval was performed by vaginal ultrasound-guided puncture 36 h after hCG administration. Oocytes incubated in IVF medium at 37 °C with 6%CO2 and 5 % O2 in air with saturated humidity. Then surrounding cumulus oophorus and corona radiata cells removed for intracytoplasmic sperm injection (ICSI). Finally Oocytes were fertilized by either insemination (IVF) or ICSI. embryos were cultured in sequential media . The women will be randomly divided into two groups .A fresh transfer was performed either on Day 3 or on day 5 after pick up.The luteal phase was supported by utrogestan vaginal( utrogestan,Besins,Brussels,Belgium ) 600 mg daily. 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 I am reviewing the subject
public Malihe Mahmoudinia
Milad Fertility Clinic, East Razi Street, Dah e Day Square,
Mashhad Iran (Islamic Republic of) 9178631973 +98 51 3853 4021 MahmoudiniaM@mums.ac.ir Mashhad University of Medical Sciences scientific Nayyereh khadem
Emam Reza Hospital, Ebne Sina Street
Mashhad Iran (Islamic Republic of) 9178631973 +98 51 3801 2607 khademn@mums.ac.ir Mashhad University of Medical Sciences Iran (Islamic Republic of) Uterine with normal cavity Normal res ponder to ovarian stimulation There are at least 5 fresh embryo Sufficient thickness of endometrium in day 12 cycles 20 years 40 years Female lack of embryo with good quality Endocrine disorder(Hypothyroidism ,diabetes) Poor respond er(less and equal 3 oocyte) Excessive responder to ovarian stimulation (more than 20oocyte) Freeze all of all embryos Refusal to cooperation in the study previous surgery of uterine Recurrent abortion Sever male factor N98.3 Complications of attempted introduction of embryo in embryo transfer Treatment - Other Treatment - Other Intervention group:Three ovarian stimulation protocols( long protocol , microdoze and antagonist protocol ) were used to prepare patients for ivf depending on their age and diagnosis. Final oocyte maturation was induced by administration of 10 000 IU hCG when at least three follicles with a diameter of 17 mm were observed during pelvic ultrasound. Oocyte retrieval was performed by vaginal ultrasound-guided puncture 36 h after hCG administration. . Oocytes incubated in IVF medium at 37 °C with 6 %CO2 and 5 % O2 in air with saturated humidity. Finally Oocytes were fertilized by either insemination (IVF) or ICSI. Embryos were cultured in sequential media . The women will be randomly divided into two groups A fresh transfer was performed either on Day 3 or on day 5 after pick up.The luteal phase was supported by utrogestan Vaginal 600 mg daily. Control group: Three ovarian stimulation protocols( long protocol , microdoze and antagonist protocol ) were used to prepare patients for ivf depending on their age and diagnosis. Final oocyte maturation was induced by administration of 10 000 IU hCG when at least three follicles with a diameter of 17 mm were observed during pelvic ultrasound. Oocyte retrieval was performed by vaginal ultrasound-guided puncture 36 h after hCG administration. Oocytes incubated in IVF medium at 37 °C with 6%CO2 and 5 % O2 in air with saturated humidity. Then surrounding cumulus oophorus and corona radiata cells removed for intracytoplasmic sperm injection (ICSI). Finally Oocytes were fertilized by either insemination (IVF) or ICSI. embryos were cultured in sequential media . The women will be randomly divided into two groups .A fresh transfer was performed either on Day 3 or on day 5 after pick up.The luteal phase was supported by utrogestan vaginal( utrogestan,Besins,Brussels,Belgium ) 600 mg daily. Clinical pregnancy rate. Timepoint: 6 weeks after embryo transfer. Method of measurement: sonography. Chemical pregnancy rate. Timepoint: 2weeks after embryo transfer. Method of measurement: βHCG test. Ongoing pregnancy. Timepoint: Continued pregnancy up to 12 weeks. Method of measurement: Trans vaginal Sonography. Mashhad University of Medical Sciences Approved 2018-07-25 Mashhad university of Medical sciences Ethics committee Mashhad University of Medical Sciences, Mashhad University of Medical Sciences,University Avenue, Mashhad Mashhad Razavi Khorasan Iran (Islamic Republic of)