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IRCT20180409039247N8 IRCT 2023-08-17 Tehran University of Medical Sciences comparing IVF results in two GnRH antagonist protocols and Stop protocol (GnRH agonist/antagonist) in patients with polycystic ovary syndrome Clinical trial comparing IVF results in two GnRH antagonist protocols and Stop protocol (GnRH agonist/antagonist) in patients with polycystic ovary syndrome 2023-08-23 anticipated 60 Complete https://irct.ir/trial/71726 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Participants will be randomly assigned to one of two groups. A computerized randomization list, generated by an independent statistician blinded to the trial, will use 1:1 allocation. The block random allocation method was designed by an epidemiologist using WWW.Sealedenvelop.com. The blocks will be 2 alleles of size 6. AAABBB-AABBAB-ABBBAA-AABABB-….., in this sequence A and B that only the main researcher knows its meaning. N/A infertility. Intervention 1: Intervention group: In the GnRH group, Stop starts in the mid-luteal phase (previous cycle) and with the onset of menstruation on the 2nd-3rd day of the gonadotropin cycle, the dose of 150-225 units subcutaneously, depending on the patient's condition. The patient takes gonads for at least 5 days, and from the 6th day of taking gonadotropin, vaginal ultrasound and follicography are performed every 2 or 3 days. When the leading follicle reaches the size of 13-14 mm, the antagonist is started, and when at least 2-3 follicles above 18 are observed, the final trigger is done with GNRH agonist, and 34-40 hours later, the puncture is done. Intervention 2: Control group: In this group, gonadotropins are started on day 2-3 of the menstrual cycle with a dose of 150-225 units subcutaneously, depending on the patient's condition. The patient takes gonads for at least 5 days, and from the 6th day of taking gonadotropin, vaginal ultrasound and follicography are performed every 2 or 3 days. When the leading follicle reaches the size of 13-14 mm, the antagonist is started, and when at least 2-3 follicles above 18 are observed, the final trigger is performed with GNRH agonist, and 34-40 hours later, the puncture is performed. 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 There is no further information
public Marjan Ghaemi
Emam khomeini hospital
Tehran Iran (Islamic Republic of) 14146 +98 21 8800 4858 marjan_ghaemi@yahoo.com Tehran University of Medical Sciences scientific Marjan Ghaemi
Emam khomeini hospital
Tehran Iran (Islamic Republic of) 14146 +98 21 8800 4858 marjan_ghaemi@yahoo.com Tehran University of Medical Sciences Iran (Islamic Republic of) PCO patients according to Rotterdam criteria Age 20 to 35 years Infertility > 1 year Sperm analysis is normal or has the minimum necessary criteria for ICSI AMH above 5 20 years 35 years Female History of autoimmune diseases, coagulation disorders, uterine anomalies, chromosomal and genetic disorders, chronic renal and metabolic diseases, hypo and hyperthyroidism, history of malignancy, endometriosis, history of repeated miscarriage and repeated implantation failure Pharmaceutical reaction to ovulation stimulation drugs Lack of follicle growth suitable for puncture The patient's lack of consent to complete the treatment course Severe Oligoastenoteratospermia N97 Female infertility Treatment - Drugs Treatment - Drugs Intervention group: In the GnRH group, Stop starts in the mid-luteal phase (previous cycle) and with the onset of menstruation on the 2nd-3rd day of the gonadotropin cycle, the dose of 150-225 units subcutaneously, depending on the patient's condition. The patient takes gonads for at least 5 days, and from the 6th day of taking gonadotropin, vaginal ultrasound and follicography are performed every 2 or 3 days. When the leading follicle reaches the size of 13-14 mm, the antagonist is started, and when at least 2-3 follicles above 18 are observed, the final trigger is done with GNRH agonist, and 34-40 hours later, the puncture is done. Control group: In this group, gonadotropins are started on day 2-3 of the menstrual cycle with a dose of 150-225 units subcutaneously, depending on the patient's condition. The patient takes gonads for at least 5 days, and from the 6th day of taking gonadotropin, vaginal ultrasound and follicography are performed every 2 or 3 days. When the leading follicle reaches the size of 13-14 mm, the antagonist is started, and when at least 2-3 follicles above 18 are observed, the final trigger is performed with GNRH agonist, and 34-40 hours later, the puncture is performed. The number of follicles above 16 mm, the degree of follicle synchrony, the number and quality of obtained oocytes (metaphase 1, 2 and GV). Timepoint: The examination will be cross-sectional on the day of oocyte puncture. Method of measurement: Questionnaire for demographic information and patient records, ultrasound to check follicles and embryology laboratory information to check the number and quality of oocytes and embryos. Number and quality of embryos. Timepoint: On the day of ovarian puncture. Method of measurement: It is determined by the embryologist three days after the puncture. Tehran University of Medical Sciences Approved 2023-07-19 Tehran university of Medical sciences East Bagherkhan Street Tehran Tehran Iran (Islamic Republic of)