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IRCT20201003048912N1 IRCT 2020-12-21 Avicenna Reseacrh Institute The effect of growth hormone on increasing pregnancy success rate in women with unexplained recurrent implantation failure: A multicenter clinical randomized study. The effect of growth hormone on increasing pregnancy success rate in women with unexplained recurrent implantation failure: A multicenter clinical randomized study. 2020-06-21 anticipated 356 Complete https://irct.ir/trial/51664 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Other, Purpose: Treatment, Other design features: The effect of growth hormone on increasing pregnancy success rate in women with unexplained recurrent implantation failure ( undergoing frozen embryo transfer): A multicenter clinical randomized study, Randomization description: Block randomization with blocks with size 4 in www.sealedenvelope.com web site. 3 Condition 1: Patients with recurrent implantation failure. Condition 2: Patients with recurrent implantation failure. Intervention 1: Intervention group: this study attempts to explore and assess 178 infertile further three recurrent implantation failures. This group will receive the growth hormone produced by CinnaGen Company for the frozen embryo transfer (FET). From the third day of menstruation, after suppression of endogenous ovarian secretion by prescribing GnRH agonist in the 21day of the previous cycle ,oral estradiol valerate (6 mg/day) and subcutaneous injection of 8 units of the growth hormone will be prescribed. ( in patients with a regular menstruation no GnRH agonist suppression is done ). The injection of the growth hormone will be continued until the day on which progesterone is injected.(having a good trilaminar ,at least 7-8 mm endometrial thickness ). Five days prior to blastocyst embryo transfer, intramuscular injection of progesterone and the oral estradiol valerate (6 mg/day) will be prescribed. In the morning of the day of embryo transfer, the subendometrial flow , endometrial thickness and volume , endometrium pulsatility index, resistance index of left and right uterine arteris are measured by 2 D and 3D ultrasonography and power Doppler sonography and the embryo is transferred then.For luteal phase support , oral estradiol valerate pulse vaginal progesterone, Cyclogest ,( 400 mg BD) or combination of vaginal progesterone, Cyclogest ,( 400 mg BD) with intramuscular progestrone( 50 mg, every 3 day) is prescribed. 2 weeks after embryo transfer, the blood BHCG test is requested. Intervention 2: Control group: this study attempts to explore and assess 178 infertile further three recurrent implantation failures. From the third day of menstruation, after suppression of endogenous ovarian secretion by prescribing GnRH agonist in the 21day of the previous cycle ,oral estradiol valerate (6 mg/day) will be prescribed. ( in patients with a regular menstruation no GnRH agonist suppression is done ). Using estradiol valerate will be continued until the day on which progesterone is injected. .(having a good trilaminar , at least 7-8 mm endometrial thickness ). Five days prior to blastocyst embryo transfer, intramuscular injection of progesterone and the oral estradiol valerate (6 mg/day) will be prescribed. In the morning of the day of embryo transfer, the subendometrial flow , endometrial thickness and volume , endometrium pulsatility index, resistance index of left and right uterine arteris are measured by 2 D and 3D ultrasonography and power Doppler sonography and the embryo is transferred then. For luteal phase support , oral estradiol valerate pulse vaginal progesterone, Cyclogest ,( 400 mg BD) or combination of vaginal progesterone, Cyclogest ,( 400 mg BD) with intramuscular progestrone( 50 mg, every 3 day) is prescribed. 2 weeks after embryo transfer, the blood BHCG test is requested.are measured and the embryo is transferred then. 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 Ethical concerns
public Dr. Mina Ataei
Yakhchal Junction, Shariati st.
Tehran Iran (Islamic Republic of) 1936773493 +98 21 2243 2020 Ataee.mina@yahoo.com Avicenna Infertility Center scientific ِDr Soheila Ansaripour
Yakhchal junction, Shariati st.
Tehran Iran (Islamic Republic of) 1936773493 +98 21 2243 2020 soh.ansaripour@gmail.com Avicenna fertility Center Iran (Islamic Republic of) Iran (Islamic Republic of) Iran (Islamic Republic of) Iran (Islamic Republic of) Iran (Islamic Republic of) Iran (Islamic Republic of) Iran (Islamic Republic of) have a history of more than two previous unexplained IVF failures (3≤)(despite transfer of minimum one good grade A blastocyst embryo) , no previous hormone growth cycle, no other interventions in this cycle(hystroscopy and Imunomodolator drugs ), no donation cycle, no hormone contraindications, not having hydrosalpinx, , having at least one good grade A blastocyst freezed embryo for transfer , FSH≤10, AMH≥1.8 22 years 39 years Female Age≥ 40 years, BMI≥30, endometriosis, severe oligospermia, (Sperm count <5 ×106 /mL ,Normal morphology <2% in the sperm analysis test ) DFI ≤30% , patients with hydrosalpinx, kidney and liver diseases, diabetes,hypertention and thyroid( anti-Tpo>500) and autoimmune diseases and local allergic reactions and benign increase in intracranial pressure, submucosal myoma, metabolic syndrome, sex selection , karyotype disorder, uterian anomalis, Synechsia, Hx of thin enodmetrium(endometrial line<7mm) , no patient consent N98.2 N97.2 Complications of attempted introduction of fertilized ovum following in vitro fertilization Female infertility of uterine origin Treatment - Drugs Treatment - Other Intervention group: this study attempts to explore and assess 178 infertile further three recurrent implantation failures. This group will receive the growth hormone produced by CinnaGen Company for the frozen embryo transfer (FET). From the third day of menstruation, after suppression of endogenous ovarian secretion by prescribing GnRH agonist in the 21day of the previous cycle ,oral estradiol valerate (6 mg/day) and subcutaneous injection of 8 units of the growth hormone will be prescribed. ( in patients with a regular menstruation no GnRH agonist suppression is done ). The injection of the growth hormone will be continued until the day on which progesterone is injected.(having a good trilaminar ,at least 7-8 mm endometrial thickness ). Five days prior to blastocyst embryo transfer, intramuscular injection of progesterone and the oral estradiol valerate (6 mg/day) will be prescribed. In the morning of the day of embryo transfer, the subendometrial flow , endometrial thickness and volume , endometrium pulsatility index, resistance index of left and right uterine arteris are measured by 2 D and 3D ultrasonography and power Doppler sonography and the embryo is transferred then.For luteal phase support , oral estradiol valerate pulse vaginal progesterone, Cyclogest ,( 400 mg BD) or combination of vaginal progesterone, Cyclogest ,( 400 mg BD) with intramuscular progestrone( 50 mg, every 3 day) is prescribed. 2 weeks after embryo transfer, the blood BHCG test is requested. Control group: this study attempts to explore and assess 178 infertile further three recurrent implantation failures. From the third day of menstruation, after suppression of endogenous ovarian secretion by prescribing GnRH agonist in the 21day of the previous cycle ,oral estradiol valerate (6 mg/day) will be prescribed. ( in patients with a regular menstruation no GnRH agonist suppression is done ). Using estradiol valerate will be continued until the day on which progesterone is injected. .(having a good trilaminar , at least 7-8 mm endometrial thickness ). Five days prior to blastocyst embryo transfer, intramuscular injection of progesterone and the oral estradiol valerate (6 mg/day) will be prescribed. In the morning of the day of embryo transfer, the subendometrial flow , endometrial thickness and volume , endometrium pulsatility index, resistance index of left and right uterine arteris are measured by 2 D and 3D ultrasonography and power Doppler sonography and the embryo is transferred then. For luteal phase support , oral estradiol valerate pulse vaginal progesterone, Cyclogest ,( 400 mg BD) or combination of vaginal progesterone, Cyclogest ,( 400 mg BD) with intramuscular progestrone( 50 mg, every 3 day) is prescribed. 2 weeks after embryo transfer, the blood BHCG test is requested.are measured and the embryo is transferred then. Pregnancy rate. Timepoint: 5-6 weeks after taking the drug. Method of measurement: The number of patients with positive gestational sac divided by the number of patients who had embryo transfer. Endometrial receptivity. Timepoint: 2 weeks after taking the drug. Method of measurement: measurement of sub endometrial flow by power Doppler sono and endometrial volume and thickness by 3D and 2D ultrasonograghy. Chemical pregnancy rate : the rate of positive pregnancy test 2 weeks after embryo transfer. Timepoint: 2 weeks after embryo transfer. Method of measurement: evaluation of positive pregnancy test after transfer of blastocyst (s) embryo(s). Implantation rate. Timepoint: measurement of number gestational sac divided by number of blastocyst embryo transfer. Method of measurement: evaluation of positive and number of intrauterine gestational sac after transfer of blastocyst (s) embryo(s) by ultrasonograghy. Live birth rate : number of delivery of viable fetuses(more than 28 weeks) divided by number of embryo transferred. Timepoint: Gestational age more than 28 weeks of pregnancy. Method of measurement: Delivery of viable fetuses after 28 after pregnancy. CinnaGen company ACECR CinnaGen company Approved 2020-09-09 Ethic committe of Avicenna research institue Yakhchal junction, Shariati st. Tehran Tehran Iran (Islamic Republic of)