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IRCT20230403057803N1 IRCT 2023-04-24 Shahid Beheshti University of Medical Sciences GNRH agonist vs GNRH antagonist in infertility treatment. Gonadotropin-releasing hormone (GnRH) agonist vs GnRH antagonist in stimulation protocol on ART outcomes in infertile endometriosis patients 2023-05-05 anticipated 120 Complete https://irct.ir/trial/69701 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Block randomization in which patients are randomly divided into two groups of 60 patients using a table of random numbers. An independent researcher makes random allocation cards using computer-generated random numbers. He keeps the original random allocation sequences in an inaccessible third place and works with a copy. Since the executors can get confused with the original coding of A and B later, the allocator should record exactly what these codes mean to avoid further confusion. Next, we print it out and put each of the sheets one by one into each envelope. The allocation sequence was concealed from the researcher (JR) enrolling and assessing participants in sequentially numbered, opaque, sealed, and stapled envelopes. 3 Infertility in endometriosis. Intervention 1: Intervention group: In the antagonist protocol, Cinnal-f® (Follitropin alfa) is injected subcutaneously daily from the second day of the cycle, and then when the follicle size reaches 14 mm and at most on day 6, Cetronax 250 mg is injected subcutaneously (Ronak Pharmaceutical Co). This medicine continues with HCG until the trigger day. Intervention 2: Control group: In the agonist protocol, from the 21st day of the previous cycle, Sinnafact with a dose of 50 mg (CinnaGen Co) is injected subcutaneously daily, and from the second day of the cycle, Cinnal-f® (with a dose depending on age and weight and the patient's ovarian reserve) and Cinnafact 20mg are injected daily and subcutaneously. Yes - There is a plan to make this available What will be shared: It is not decided yet When: It is not decided yet To whom: It is not decided yet Conditions: It is not decided yet Where to obtain: It is not decided yet How to obtain: It is not decided yet Comments:
public Sedighe Hosseini
Shahid Arabi Street
Tehran Iran (Islamic Republic of) 1985711161 +98 21 2303 1111 taleghanihospital@sbmu.ac.ir Shahid Beheshti University of Medical Sciences scientific Mitra Nemati
Shahid Arabi Street
Tehran Iran (Islamic Republic of) 1985711151 +98 21 2303 1111 mithraa.nemati@gmail.com Shahid Beheshti University of Medical Sciences Iran (Islamic Republic of) Patients aged between 20 and 40 years Patients with endometriosis without a history of endometriosis surgery Patients with anti-mullerian hormone (AMH) level > 1ng/ml Number of antral follicle count (AFC)>5 Patients with Ca125<200 Absence of untreated endocrine disease 20 years 40 years Female Patients with uterine structural problems such as polyps or fibroids Patients with genetic disorders Patients with a history of poor response to stimulation in previous cycles History of ovarian hyperstimulation syndrome (OHSS) N80 Endometriosis Treatment - Drugs Treatment - Drugs Intervention group: In the antagonist protocol, Cinnal-f® (Follitropin alfa) is injected subcutaneously daily from the second day of the cycle, and then when the follicle size reaches 14 mm and at most on day 6, Cetronax 250 mg is injected subcutaneously (Ronak Pharmaceutical Co). This medicine continues with HCG until the trigger day. Control group: In the agonist protocol, from the 21st day of the previous cycle, Sinnafact with a dose of 50 mg (CinnaGen Co) is injected subcutaneously daily, and from the second day of the cycle, Cinnal-f® (with a dose depending on age and weight and the patient's ovarian reserve) and Cinnafact 20mg are injected daily and subcutaneously. Oocyte and embryo count and quality. Timepoint: One month after the treatment (it is not possible to compare before and after the treatment within groups. we can only compare the two groups after the treatment.). Method of measurement: Embryologist assessment based on microscopic criteria. Shahid Beheshti University of Medical Sciences Approved 2023-03-13 Ethic commitee of faculty of medicine. Shahid Beheshti University of Medical Sciences Taleghani hospital, Arabi street, Velenjak, Chamran Highway, Tehran Tehran Tehran Iran (Islamic Republic of)