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IRCT20110509006420N28 IRCT 2024-01-30 Yazd University of Medical Sciences Evaluation of GnRH long-acting agonist protocols and GnRH antagonist protocol in controlled ovarian stimulation in in vitro fertilization in infertile women with poor ovarian response Evaluation and comparison of GnRH antagonist versus long GnRH agonist protocol in poor responders undergoing IVF from POSEIDON group3- 4: A randomized clinical trial 2024-01-30 anticipated 170 Complete https://irct.ir/trial/74745 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: In this study, using the simple randomization method using the Random Allocation1 software (http://random-allocation software.informer.com\1) and based on the simple randomization method, the list of samples in the two groups studied by the expert Statistics will be generated. In this software, in order to generate a list of random numbers, first specify the number of groups to be studied as 2 and the total number of samples required as 170 people, and then from the list of sample randomization methods, the method (simple randomization method in parallel group) by considering the same number of samples in the groups. Then a random list will be generated based on the groups and the number of samples in each group. Randomly and after obtaining informed consent by the researcher, they are assigned to two groups. The sealed envelope method is used for concealment. The envelopes are prepared as many samples as each envelope contains the name of the intervention group for each sample. Is. 3 Infertility. Intervention 1: The GnRH antagonist group will start from the second day of the menstrual cycle, the ultrasound of gonadotropin IU225-300 rFSH signal-F daily subcutaneous injection. Then, if there is a dominant follicle ≥ 14 mm, the GNRH antagonist (Cetrotide 0.25 mg) is prescribed and will continue until the ovulation trigger day. With ultrasound monitoring, when there are The average follicle is ≥17 mm or one follicle is 18 mm, 10,000 hCG units were injected to induce the final maturation of follicles on the same day. Endometrial thickness and serum E2 level were measured for all 34-36 hours after the trigger under general anesthesia and ovarian puncture will be performed by ultrasound. became. 72 hours after ovarian puncture, two three-day-old embryos will be transferred and the remaining embryos will be frozen. If there is serum progesterone level ≥ 1.5ng/ml, all embryos will be frozen. Intervention 2: Intervention group: In the GnRH agonist long protocol group, they received a zoladex 3.6 mg dose of GnRH depot analog sc from day 21 of the cycle before ovarian stimulation. From the second day of the menstrual cycle, the ultrasound of gonadotropin IU225-300 rFSH signal-F will be injected daily subcutaneously. The dose of the drug will be adjusted according to the response of the ovary and will continue until the ovulation trigger day. With ultrasound monitoring, whenThe average follicle is ≥17 mm or one follicle is 18 mm In order to induce the final maturation of the follicle, 10,000 units of HCG were injected on the same day. Endometrial thickness and E2 serum level were measured for all 34-36 hours after the trigger under general anesthesia and ovarian puncture will be performed under ultrasound guidance. 72 hours after ovarian puncture, two three-day-old embryos will be transferred and the remaining embryos will be frozen. If there is serum progesterone level ≥ 1.5ng/ml, all embryos will be frozen. Yes - There is a plan to make this available What will be shared: All participant data sets are to be shared When: 2 months after the result publication To whom: In order to receive data or other study documents, researchers working in academic and scientific institutions are allowed to apply Conditions: To evaluate the accuracy of the data and use data to complete other researches Where to obtain: Yazd Reproductive Sciences Institute, Bouali Ave, Yazd, Iran How to obtain: Request from the Research Deputy, submitted to the Research Council of the Center if the request accepts its referral to the security and after completion of the relevant forms, the request is referred to the research experts and then get the data. Comments:
public maryam eftekhar
Yazd Reproductive Sciences Institute, BouAl Ave,Safaeih، Yazd, Yazd Province
yazd Iran (Islamic Republic of) ۸۹۱۶۸۷۷۳۹۱ +98 35 3824 7085 eftekhar@ssu.ac.ir Yazd University of Medical Sciences scientific maryam eftekhar
Yazd Reproductive Sciences Institute, BouAl Ave,Safaeih، Yazd, Yazd Province
yazd Iran (Islamic Republic of) ۸۹۱۶۸۷۷۳۹۱ +98 35 3824 7085 eftekhar@ssu.ac.ir Yazd University of Medical Sciences Iran (Islamic Republic of) IVF/ICSI candidates Women who respond poorly to ovulation stimulation: ovarian reserve less than 1.2 ng/ml and AFC number less than 5 POSEIDON group 3-4 Women between the ages of 18 and 42 18 years 42 years Female sever Asherman's history Severe uterine adenomyosis Egg donation cycles Cases of severe male infertility (azoospermia) Cases where surrogacy is used Endocrine or metabolic diseases (hypothyroidism, hyperthyroidism) N97 Female infertility Treatment - Drugs Treatment - Drugs The GnRH antagonist group will start from the second day of the menstrual cycle, the ultrasound of gonadotropin IU225-300 rFSH signal-F daily subcutaneous injection. Then, if there is a dominant follicle ≥ 14 mm, the GNRH antagonist (Cetrotide 0.25 mg) is prescribed and will continue until the ovulation trigger day. With ultrasound monitoring, when there are The average follicle is ≥17 mm or one follicle is 18 mm, 10,000 hCG units were injected to induce the final maturation of follicles on the same day. Endometrial thickness and serum E2 level were measured for all 34-36 hours after the trigger under general anesthesia and ovarian puncture will be performed by ultrasound. became. 72 hours after ovarian puncture, two three-day-old embryos will be transferred and the remaining embryos will be frozen. If there is serum progesterone level ≥ 1.5ng/ml, all embryos will be frozen. Intervention group: In the GnRH agonist long protocol group, they received a zoladex 3.6 mg dose of GnRH depot analog sc from day 21 of the cycle before ovarian stimulation. From the second day of the menstrual cycle, the ultrasound of gonadotropin IU225-300 rFSH signal-F will be injected daily subcutaneously. The dose of the drug will be adjusted according to the response of the ovary and will continue until the ovulation trigger day. With ultrasound monitoring, whenThe average follicle is ≥17 mm or one follicle is 18 mm In order to induce the final maturation of the follicle, 10,000 units of HCG were injected on the same day. Endometrial thickness and E2 serum level were measured for all 34-36 hours after the trigger under general anesthesia and ovarian puncture will be performed under ultrasound guidance. 72 hours after ovarian puncture, two three-day-old embryos will be transferred and the remaining embryos will be frozen. If there is serum progesterone level ≥ 1.5ng/ml, all embryos will be frozen. Clinical pregnancy. Timepoint: 4 weeks after embryo transfer. Method of measurement: sonography. Rate of early abortion. Timepoint: the loss of the gestational sac or fetal heartbeat in clinically pregnant individuals prior to 8 weeks of gestational age. Method of measurement: sonography. نرخ حاملگی مداوم. Timepoint: the continuation of pregnancy after 12 wk of gestational age. Method of measurement: sonography. Chemical pregnancy. Timepoint: 2 weeks after embryo transfer. Method of measurement: pregnancy test. Implantation. Timepoint: After a positive pregnancy test. Method of measurement: sonography. Yazd University of Medical Sciences Approved 2024-01-10 Ethics committee of Yazd reproductive Sience Institute- Shahid Sadoghi University of Medical Science Yazd Reproductive Sciences Institute, BouAl Ave,Safaeih، Yazd, Yazd Province Yazd Yazd Yazd Iran (Islamic Republic of)