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IRCT20181030041503N8 IRCT 2023-11-13 Mashhad University of Medical Sciences Evaluation of pregnancy success in infertile people with low ovarian reserve and less than 35 years old in IVF method with two different protocols. Evaluation of the pregnancy outcome in the GnRH antagonist protocol with pretreatment in the luteal phase (including oral estradiol with or without GnRH antagonist) in comparison with the microdose GnRH agonist protocol in poor responder patients (Poseidon 3) in patients undergoing fertility treatment at the Milad Infertility Center.(randomized clinical trial) 2023-11-22 anticipated 105 Complete https://irct.ir/trial/73623 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: In this study, permutation blocks method was used to generate the sequence of random assignment of people to the studied groups. Random allocation sequence of people was done using Random Allocation Software and random block size. Therefore, the first person is assigned to the control group, the second person to intervention group 2, the third person to the control group, etc. and this process continues until all samples are assigned. The characteristic of this method is that the two study groups will have equal numbers, Blinding description: Sealed envelopes are used to hide the allocation. Based on the order of arrival of the research units, the envelopes are opened in order and the allocated group is revealed. The patient and the analyst are unaware of the type of treatment. 0 (exploratory trials) Infertility. Intervention 1: Intervention group: In the first group, from the 19th day of the previous cycle, oral estradiol is prescribed at a dose of 4 mg daily for 10 days. Gonadotropins start on the third day of the next period. Intervention 2: Intervention group: In the second group, in addition to oral estradiol, cetrorelix (cetrotide 0.25 mg) subcutaneous ampoule will be added for 3 days from the 26th day of the cycle.Gonadotropins start on the third day of the next period. Intervention 3: Control group: First, on the 4th day of the cycle, for 2 weeks, OCP is prescribed, and on the second day of the next menstrual cycle, the GnRH agonist with a dose of 50 micrograms of CinnaFact (buserelin 5.5mg)) subcutaneously, and on the third day of the menstrual cycle, gonadotropins are started. No - There is not a plan to make this available Justification or reason for not sharing IPD is I'm looking into the matter
public malihe mahmoudinia
Imam Reza Hospital, Imam Reza St., Mashhad, Iran
mashhad Iran (Islamic Republic of) 9178943791 +98 51 3853 4021 mahmoudiniam@mums.ac.ir Mashhad University of Medical Sciences scientific Ezat Shabani
Imam Reza Hospital, Imam Reza St., Mashhad, Iran
mashhad Iran (Islamic Republic of) 9178943791 +98 51 3853 4021 shabanidr960@Gmail.com Mashhad University of Medical Sciences Iran (Islamic Republic of) Infertile women candidates for IVF under 35 years of age with regular cycles and low ovarian reserves (AMH<1.2 and AFC<5) 20 years 35 years Female Male factor of infertility (severe), having moderate to severe endometriosis, having adenomyosis, or having uterine myoma other than subserous myoma with any syzymoma less than 4 cm, BMI>30 N98.3 Complications of attempted introduction of embryo in embryo transfer Treatment - Drugs Treatment - Drugs Treatment - Drugs Intervention group: In the first group, from the 19th day of the previous cycle, oral estradiol is prescribed at a dose of 4 mg daily for 10 days. Gonadotropins start on the third day of the next period. Intervention group: In the second group, in addition to oral estradiol, cetrorelix (cetrotide 0.25 mg) subcutaneous ampoule will be added for 3 days from the 26th day of the cycle.Gonadotropins start on the third day of the next period. Control group: First, on the 4th day of the cycle, for 2 weeks, OCP is prescribed, and on the second day of the next menstrual cycle, the GnRH agonist with a dose of 50 micrograms of CinnaFact (buserelin 5.5mg)) subcutaneously, and on the third day of the menstrual cycle, gonadotropins are started. Total number of oocytes. Timepoint: Total number of M2 oocytes. Method of measurement: After picking up and laboratory examination. Chemical pregnancy. Timepoint: n 2 week after embryo transfer. Method of measurement: BHCG. The rate of clinical pregnancy. Timepoint: 6 weeks after embryo transfer. Method of measurement: Sonography. Ongoing pregnancy. Timepoint: Continue pregnancy for up to 20 weeks. Method of measurement: Sonography. Mashhad University of Medical Sciences Approved 2023-10-23 Mashhad university of medical sciences Ethics committee Imam Reza Hospital, Imam Reza St., Mashhad, Iran mashhad Razavi Khorasan Iran (Islamic Republic of)