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IRCT20130603013566N12 IRCT 2023-04-11 Vice chancellor for Research,Tabriz University Of Medical Sciences Comparing the results of ovulation stimulationDouble or dual stimulation in poor ovarian responders Comparison of Dual Stimulation In Vitro Fertilization(IVF)-Intra Cytoplasmic Sperm Injection (ICSI) in one cycle with IVF-ICSI in two separate cycles in Poor Responder Patients 2023-04-13 anticipated 40 Complete https://irct.ir/trial/69098 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: The randomization method used in this study is the use of a table of random numbers.Random number table is a set of numbers that is generated without a specific pattern or order and they generated randomly and they are formed in a table.In first the direction of reading the numbers was specified.To read the numbers, random numbers are read from the left side of the table, then even numbers extracted from the table are allocated to intervention group and odd numbers extracted from the table are allocated to intervention control group. N/A Infertility. Intervention 1: Intervention group: The time interval from the previous In Vitro Fertilization(IVF)-Intra Cytoplasmic Sperm Injection (ICSI) will be at least 2-3 months. And during this period, patients will receive auxiliary treatment including one daily zinc tablet, Dehydroepiandrosterone capsule with a dose of 100 mg daily, vitamin D and folic acid.From the 2nd day of the menstrual cycle, after performing an ultrasound and not seeing an ovarian cyst or follicle above 13 mm, letrozole 2.5 mg tablets will be taken twice every night, and from the 3rd or 4th day of the period,Follicle-Stimulating Hormone( FSH) ampoules (signal F_) with a dose 225 daily units will start, from the 6th day of menstruation, 1-2 HMG KARMA ampoules (75 to 150) units will be added to the treatment regimen. 5-6 days after the start of gonadotropins, patients will be visited and transvaginal ultrasound will be done.Based on the size of the follicles in the transvaginal ultrasound, the treatment with gonadotropin will continue and if needed, the dose of gonadotropin will be increased up to a maximum of 300 units of FSH and a maximum of 150 units of Human chorionic gonadotropin (hCG) HMG.When the follicle size reaches 13-14 mm, GnRH antagonist (Stronax - Cinagen 250 micrograms) will be added to the treatment regimen. In the future, patients will be visited every two days. After the follicles reach a size of 17 mm or more, administration (10,000 units of HCG) will be administered and 34 to 36 hours later, oocyte recovery will be done.In the patients of the intervention group (Duostim), three days later, i.e. in the luteal phase, a repeat visit will be performed and a new cycle of IVF-ICSI will start, similar to the cycle of follicular phase treatment. If a hemorrhagic cyst is observed in the ovary, caused by previous ovulation, the patients will be excluded from the study group and new ovulation stimulation will not start. Intervention 2: Control group: The time interval from the previous In Vitro Fertilization(IVF)-Intra Cytoplasmic Sperm Injection (ICSI) will be at least 2-3 months. And during this period, patients will receive auxiliary treatment including one daily zinc tablet, Dehydroepiandrosterone capsule with a dose of 100 mg daily, vitamin D and folic acid.From the 2nd day of the menstrual cycle, after performing an ultrasound and not seeing an ovarian cyst or follicle above 13 mm, letrozole 2.5 mg tablets will be taken twice every night, and from the 3rd or 4th day of the period,Follicle-Stimulating Hormone( FSH) ampoules (signal F_) with a dose 225 daily units will start, from the 6th day of menstruation, 1-2 HMG KARMA ampoules (75 to 150) units will be added to the treatment regimen. 5-6 days after the start of gonadotropins, patients will be visited and transvaginal ultrasound will be done.Based on the size of the follicles in the transvaginal ultrasound, the treatment with gonadotropin will continue and if needed, the dose of gonadotropin will be increased up to a maximum of 300 units of FSH and a maximum of 150 units of Human chorionic gonadotropin (hCG) HMG.When the follicle size reaches 13-14 mm, GnRH antagonist (Stronax - Cinagen 250 micrograms) will be added to the treatment regimen. In the future, patients will be visited every two days. After the follicles reach a size of 17 mm or more, administration (10,000 units of HCG) will be administered and 34 to 36 hours later, oocyte recovery will be done.In the patients of the control group, IVF-ICSI will be started again, according to the usual procedure of the infertility department, at least 1-2 months after the start of the menstrual cycle. 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 After the completion of the project, the decision will be made
public Kobra Hamdi
Tabriz University Of Medical Sciences, Golgasht Street
Tabriz Iran (Islamic Republic of) 5138665793 +98 35519161 lahroudin@gmail.com Tabriz University of Medical Sciences scientific Kobra Hamdi
Tabriz University Of Medical Sciences, Golgasht Street
Tabriz Iran (Islamic Republic of) 5138665793 +98 41 1554 1221 lahroudin@gmail.com Tabriz University of Medical Sciences Iran (Islamic Republic of) The patients with first type of infertility Age 20 to 42 years 20 years 42 years Female Severe oligospermia BMI is 30 or higher Severe endometriosis Concomitant chronic disease Smoking and alcohol consumption N97.0 Female infertility associated with anovulation Treatment - Drugs Treatment - Drugs Intervention group: The time interval from the previous In Vitro Fertilization(IVF)-Intra Cytoplasmic Sperm Injection (ICSI) will be at least 2-3 months. And during this period, patients will receive auxiliary treatment including one daily zinc tablet, Dehydroepiandrosterone capsule with a dose of 100 mg daily, vitamin D and folic acid.From the 2nd day of the menstrual cycle, after performing an ultrasound and not seeing an ovarian cyst or follicle above 13 mm, letrozole 2.5 mg tablets will be taken twice every night, and from the 3rd or 4th day of the period,Follicle-Stimulating Hormone( FSH) ampoules (signal F_) with a dose 225 daily units will start, from the 6th day of menstruation, 1-2 HMG KARMA ampoules (75 to 150) units will be added to the treatment regimen. 5-6 days after the start of gonadotropins, patients will be visited and transvaginal ultrasound will be done.Based on the size of the follicles in the transvaginal ultrasound, the treatment with gonadotropin will continue and if needed, the dose of gonadotropin will be increased up to a maximum of 300 units of FSH and a maximum of 150 units of Human chorionic gonadotropin (hCG) HMG.When the follicle size reaches 13-14 mm, GnRH antagonist (Stronax - Cinagen 250 micrograms) will be added to the treatment regimen. In the future, patients will be visited every two days. After the follicles reach a size of 17 mm or more, administration (10,000 units of HCG) will be administered and 34 to 36 hours later, oocyte recovery will be done.In the patients of the intervention group (Duostim), three days later, i.e. in the luteal phase, a repeat visit will be performed and a new cycle of IVF-ICSI will start, similar to the cycle of follicular phase treatment. If a hemorrhagic cyst is observed in the ovary, caused by previous ovulation, the patients will be excluded from the study group and new ovulation stimulation will not start. Control group: The time interval from the previous In Vitro Fertilization(IVF)-Intra Cytoplasmic Sperm Injection (ICSI) will be at least 2-3 months. And during this period, patients will receive auxiliary treatment including one daily zinc tablet, Dehydroepiandrosterone capsule with a dose of 100 mg daily, vitamin D and folic acid.From the 2nd day of the menstrual cycle, after performing an ultrasound and not seeing an ovarian cyst or follicle above 13 mm, letrozole 2.5 mg tablets will be taken twice every night, and from the 3rd or 4th day of the period,Follicle-Stimulating Hormone( FSH) ampoules (signal F_) with a dose 225 daily units will start, from the 6th day of menstruation, 1-2 HMG KARMA ampoules (75 to 150) units will be added to the treatment regimen. 5-6 days after the start of gonadotropins, patients will be visited and transvaginal ultrasound will be done.Based on the size of the follicles in the transvaginal ultrasound, the treatment with gonadotropin will continue and if needed, the dose of gonadotropin will be increased up to a maximum of 300 units of FSH and a maximum of 150 units of Human chorionic gonadotropin (hCG) HMG.When the follicle size reaches 13-14 mm, GnRH antagonist (Stronax - Cinagen 250 micrograms) will be added to the treatment regimen. In the future, patients will be visited every two days. After the follicles reach a size of 17 mm or more, administration (10,000 units of HCG) will be administered and 34 to 36 hours later, oocyte recovery will be done.In the patients of the control group, IVF-ICSI will be started again, according to the usual procedure of the infertility department, at least 1-2 months after the start of the menstrual cycle. Number of resulted oocytes. Timepoint: The day of oocytes pick up. Method of measurement: Microscopic evaluation. Quality of resulted oocytes. Timepoint: The day of oocytes pick up. Method of measurement: Microscopic evaluation. Dosage of Follicle-stimulating hormone.(FSH). Timepoint: From day 2 until the time of injection. Method of measurement: Number of follicle stimulating (FSH) hormone ampoules. Dosage of Generic human menopausal gonadotropin (hMG). Timepoint: From day 2 until the time of injection. Method of measurement: Number of Generic human menopausal gonadotropin (hMG). Implantation rate. Timepoint: 4-6 weeks after embryos transfer (ET). Method of measurement: Vaginal sonography. Ongoing pregnancy rate. Timepoint: Pregnancy after 12 weeks of gestation. Method of measurement: Ultrasound. Vice chancellor for Research,Tabriz University Of Medical Sciences Approved 2023-02-20 Ethics Committee Of Tabriz University Of Medical Sciences Third Floor; Central Building of Number2; Golgasht Street Tabriz East Azarbaijan Iran (Islamic Republic of)