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IRCT20230506058097N1 IRCT 2023-06-06 Shahid Beheshti University of Medical Sciences Comparison of the efficacy of dual trigger HCG and GnRH agonist compared to HCG only in women with poor response undergoing with antagonist protocol Comparison of the efficacy of dual trigger HCG and GnRH agonist compared to HCG only in women with poor response undergoing with antagonist protocol 2023-06-22 anticipated 152 Complete https://irct.ir/trial/69962 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: The block randomization method will be permutation. Individual randomization unit and block size is 4. The intervention will be repeated twice in each block of each group. As a result, we will have 6 different blocks, each of which will be numbered arbitrarily from 1 to 6. Then, using the code of the statistical program in the R software environment version 3.6.1, 38 blocks of 4 will be produced, which will produce a sequence of size 152 in total. Using this list, patients will be assigned to the HCG stimulation or dual stimulation group, Blinding description: Due to the fact that the specialist doctor is aware of the type of intervention, it is not possible to blind the doctor in this study. According to the number of injections and the type of medicine, the patient will know in which group she belongs, so the patient will not be blinded. Blinding will only be possible for the outcome evaluation group, so that the results will be sent to this group in the form of codes A and B, and it will not be clear whether group A is the test group or the control group. N/A Condition 1: Decreased ovarian reserve. Condition 2: Infertility. Condition 3: Poor response to ovarian stimulation. Intervention 1: Intervention group: In this group, ovarian stimulation will be done with two GNRH agonist drugs and HCG drug. Buserlin agonist drug (Sinafect) manufactured by Sinagen company with a dose of 0.5 mg will be injected subcutaneously 36 hours before egg retrieval. The used HCG drug, Ovitrel manufactured by Merc company, with a dose of 250 micrograms, will be injected subcutaneously at the same time as the agonist drug. Intervention 2: Control group: In this group, stimulation will be done with a drug. Only the HCG drug under the brand name Ovitrel manufactured by Merc company with a dose of 250 micrograms is injected subcutaneously 36 hours before egg retrieval. 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 more information
public Farinaz Shahmoradi
Shishe Gar khaneh Alley, Fadaian Islam Ave, Shoosh Sq, Tehran, Iran
Tehran Iran (Islamic Republic of) 1185817311 098 21 55082628 miss.shahmoradi@yahoo.com Shahid Beheshti University of Medical Sciences scientific Shahrzad Zademodarres
Shishe Gar khaneh Alley, Fadaian Islam Ave, Shoosh Sq, Tehran, Iran
Tehran Iran (Islamic Republic of) 1185817311 +98 21 5506 2628 shahrzad.modarres2014@gmail.com Shahid Beheshti University of Medical Sciences Iran (Islamic Republic of) Women of reproductive age (from 15 to 45) with poor ovarian response who have at least two of the following criteria according to the Bologna criteria: age greater than or equal to 40 years, history of poor response with a maximum number of three oocytes obtained after stimulation or abnormal ovarian reserve confirmed by one of the two AFC test less than or equal to 7 or AMH less than or equal to 1.2 In the absence of criteria for old age or abnormal ovarian reserve, if a woman has a history of two weak responses after maximal ovarian stimulation Informed consent of clients to enter the research 15 years 45 years Female Azospermia in the client's wife Women with polycystic ovary syndrome N97.0 N97 Female infertility associated with anovulation Female infertility Treatment - Drugs Treatment - Drugs Intervention group: In this group, ovarian stimulation will be done with two GNRH agonist drugs and HCG drug. Buserlin agonist drug (Sinafect) manufactured by Sinagen company with a dose of 0.5 mg will be injected subcutaneously 36 hours before egg retrieval. The used HCG drug, Ovitrel manufactured by Merc company, with a dose of 250 micrograms, will be injected subcutaneously at the same time as the agonist drug. Control group: In this group, stimulation will be done with a drug. Only the HCG drug under the brand name Ovitrel manufactured by Merc company with a dose of 250 micrograms is injected subcutaneously 36 hours before egg retrieval. The number of oocyte obtained. Timepoint: 8 to 14 days after stimulation (according to ovarian response). Method of measurement: Observation (with microscope) and counting of eggs in the laboratory by an embryologist. Chemical pregnancy. Timepoint: two weeks after embryo transfer. Method of measurement: Blood sampling, Measurement of BHCG Titer. Clinical pregnancy. Timepoint: eight weeks after embryo transfer. Method of measurement: Ultrasound, visualization of the gestational sac and fetal heart. Abortion. Timepoint: any time before 20 weeks of gestation. Method of measurement: Removal of pregnancy products before week 20. Shahid Beheshti University of Medical Sciences Approved 2023-04-30 Ethics committee of Shahid Beheshti University of Medical Science Floor 13, Block A, Ministry of Health & Medical Education Headquarters, Between Zarafashan & South Falamak, Qods Town, Tehran, Iran. Tehran Tehran Iran (Islamic Republic of)