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IRCT20180409039247N7 IRCT 2023-07-31 Tehran University of Medical Sciences Comparison of folic acid and folate consumption on ovarian reserve parameters and IVF results Comparison of folic acid and folate consumption on ovarian reserve parameters and IVF results in women referred to infertility clinic - a randomized, blinded clinical trial 2023-08-23 anticipated 280 Complete https://irct.ir/trial/71681 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: participants will be randomly assigned to folic acid and folate groups. A computerized randomization list, generated by an independent statistician blinded to the trial and unrelated to the subjects involved, will use 1:1 allocation. All participants are blinded to the list. The randomization list will be administered using identical, sequentially numbered study drug containers, and these containers will be identically labeled by two investigators who will not be involved in the recruitment of study subjects. The block random allocation method was designed by an epidemiologist using WWW.Sealedenvelop.com. The blocks will be 2 alleles of size 6. AAABBB-AABBAB-ABBBAA-AABABB-….., in this sequence, A is folic acid and B is folate, Blinding description: The list of random allocation of patients will only be at the disposal of the project epidemiologist. In order to hide the random allocation process, the relevant type of treatment will be written on cardboard cards and placed in paper envelopes of the same shape. Only the project methodologist will be aware of the contents of the envelopes. The cards will be arranged in the order of the randomization list inside the box. When the doctor declares the eligibility of a patient, the methodologist will provide the envelope design to the therapist. The person evaluating the intended outcomes is a third person who is unaware of the randomization process and the type of treatment performed. In order to analyze the data, a statistician who is separate from the study process and is unaware of all the processes will be used. It should be noted that the medicines of one form are provided by the pharmaceutical company to the project manager to be prescribed to the patients. N/A infertility. Intervention 1: Intervention group: oral folate tablets 600 micrograms daily. Intervention 2: Control group: 1 mg oral folic acid tablet. No - There is not a plan to make this available Justification or reason for not sharing IPD is here is no further information
public Marjan Ghaemi
No. 25 Naz Alley, Babataher St
Tehran Iran (Islamic Republic of) 14146 +98 912 196 7735 marjan_ghaemi@yahoo.com Tehran University of Medical Sciences scientific Marjan Ghaemi
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fkj Iran (Islamic Republic of) 14146 +98 21 8800 4858 marjan_ghaemi@yahoo.com Tehran University of Medical Sciences Iran (Islamic Republic of) Infertile women aged 30-40 with poor response or unknown causes of infertility are candidates for IVF 30 years 40 years Female Infertility due to PCO; endometriosis; tubal and uterine and having causes of male infertility History of ovarian or pelvic surgery or medical history of chemotherapy or radiotherapy. Diseases associated with viral infections (hepatitis), tumors, autoimmune diseases, endocrine disorders, metabolic disorders or acute inflammation. Patients with definite diagnosis of hereditary diseases or family history of hereditary thrombophilic diseases in family or person. History of multivitamin use N97 Female infertility Treatment - Drugs Treatment - Drugs Intervention group: oral folate tablets 600 micrograms daily Control group: 1 mg oral folic acid tablet Primary outcome: changes in the number of antral follicles. Secondary outcome: changes in FSH, AMH and Inhibin B and checking the level of possible side effects. Timepoint: The results will be evaluated at the beginning of the study and after three months from the start of the study. Method of measurement: To check AFC vaginal ultrasound and to measure FSH, AMH and Inhibin laboratory (blood sample) will be used. Tehran University of Medical Sciences Approved 2023-07-19 Tehran university of medical sciences East Bagherkhan Street, Imam Complex Tehran Tehran Iran (Islamic Republic of)