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

This study aims to compare the consumption of folic acid and folate on ovarian reserve parameters and IVF results in women referred to infertility clinics.

Clinical trial with control group, with parallel groups, single-blind, randomized, on 280 patients. The block random assignment method was designed by an epidemiologist.

280 women suffering from infertility referred to the infertility clinic of Waliasr Hospital, where each person is given one pill (folic acid or folate) with the same appearance and daily for 3 months. The patient and the analyst are blinded to the study. In order to hide the random allocation process, the corresponding type of treatment will be written on cardboard cards and placed in identical paper envelopes. . The cards will be arranged in the order of the randomization list in a box. For data analysis, a statistician who is separate from the study process and unaware of all the processes will be used.

Inclusion criteria - Infertile women aged 30-40 years. (poor response and unknown cause of infertility b. exclusion criteria - 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. - Other medical Diseases - Patients with definite diagnosis of hereditary diseases or family history of hereditary thrombophilic diseases in family or person. History of multivitamin use

The participants will be randomly assigned to the group of folic acid 1 mg daily (control group) and folate 600 micrograms daily (case group) with the shape and appearance of Bexan for 3 months.

Primary: changes in AFC Secondary: changes in FSH, AMH and Inhibin B and side effects

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.

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.

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