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IRCT20191205045621N2 IRCT 2020-05-24 Shiraz University of Medical Sciences Effect of medroxyprogesterone acetate in the prevention of premature LH surge in IVF cycles Evaluation of oral Medroxyprogesterone acetate effect in the prevention of premature LH surge in IVF cycles in comparison with antagonist protocol 2020-05-21 anticipated 100 Complete https://irct.ir/trial/46951 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Simple randomization: Patients will be recruited consecutively and allocated to one of the two groups in an alternating fashion. Odd-numbered participants will be allocated to the MPA group and even-numbered participants will be assigned to the Antagonist protocol, Blinding description: Patients will be aware of the type of medication they receive and the second executor of the research project will collect primary data at the end of the treatment without knowledge of the two groups. Also the data will be analyzed without any information about group selection. N/A infertility. Intervention 1: Intervention group: the group will be administered hMG (150–225 IU) and MPA (10 mg/d) from MC3 onward. Intervention 2: Control group: the group will be administered hMG (150–225 IU) and Triptorelin 0.1 mg SQ and 1500 IU hCG. 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 Mina Moosaie
Zand Street
Shiraz Iran (Islamic Republic of) 7134814336 +98 71 3230 5410 moosaie.mina@gmail.com Shiraz University of Medical Sciences scientific Mina Moosaie
Zand Street
Shiraz Iran (Islamic Republic of) 7134814336 +98 71 3230 5410 moosaie.mina@gmail.com Shiraz University of Medical Sciences Iran (Islamic Republic of) age under 42 years regular menstrual cycles over the previous 3-month period antral follicle count (AFC) of 7-24 on menstrual cycle day 2–3 Normal TSH and Prolactin levels no limit 42 years Female endometriosis grade 3 or higher diagnosis of polycystic ovarian syndrome presence of ovarian cyst hormone treatment receipt within the previous 3-month period low ovarian reserve (AMH<1.1 or AFC<7) any contraindication to ovarian stimulation treatment basal serum FSH concentration of more than 10 IU/L N97.9 Female infertility, unspecified Treatment - Drugs Treatment - Drugs Intervention group: the group will be administered hMG (150–225 IU) and MPA (10 mg/d) from MC3 onward Control group: the group will be administered hMG (150–225 IU) and Triptorelin 0.1 mg SQ and 1500 IU hCG Number of oocytes retrieved. Timepoint: on day of oocyte retrieval. Method of measurement: count. Number of mature oocytes. Timepoint: on day of oocyte retrieval. Method of measurement: count. Clinical pregnancy. Timepoint: 3 weeks after IVF. Method of measurement: Measurement of beta-hCG. Embryos number. Timepoint: after 24 hours and day 5. Method of measurement: microscopic evaluation. Fertilization rate. Timepoint: 24 hours after intra-cytoplasmic sperm injection. Method of measurement: microscope. Implantation rate. Timepoint: 2 weeks after embryo transfer. Method of measurement: Measurement of beta-hCG. Shiraz University of Medical Sciences Approved 2019-12-15 Ethics committee of Shiraz university of Medical Science Zand street- central building of Shiraz University of Medical Sciences-Shiraz Shiraz Fars Iran (Islamic Republic of)