The effect of inofolic supplementation in combination with probiotics and vitamin D on ovarian response and metabolic profiles in women with polycystic ovary syndrome candidate for In Vitro Fertilization

Determining the effect of inofolic supplementation and its combination with probiotics and vitamin D on ovarian response and metabolic profiles in women with polycystic ovary syndrome (PCOS) candidate for In vitro fertilization (IVF)

Randomized clinical trial, double blind, controlled with placebo, parallel, single center

Among patients with PCOS candidate for IVF referred to Mahdie Clinic affiliated to Shahid Beheshti University of Medical Sciences, 120 patients will be selected according to inclusion and exclusion criteria. Participants, investigators or the assessors of the outcomes are unaware of the study groups. Supplements and placebos are similar in shape and size. Fasting blood samples will be taken at baseline and 8 weeks after the intervention.

Inclusion Criteria: Women with PCOS according to the Rotterdam criteria, In Vitro Fertilization candidate, Age 45-30 years, No smoking, Male reproductive health

Intervention group 1: Inofolic Sachet ; Inositol 2gr, twice a day(Teb mofid nikan)plus probiotic Capsule (1.8 ×109 CFU/capsule),One capsule per day( Takgene Zist) plus Vitamin D Capsule; 4000 IU ,One capsule per day( Daana). Intervention group 2: Inofolic Sachet ; Inositol 2gr, twice a day plus probiotic Capsule (1.8 ×109 CFU/capsule),One capsule per day plus Vitamin D placebo; Sunflower oil, One capsule per day (Daana) .Intervention group 3: Inofolic Sachet ; Inositol 2gr, twice a day plus Probiotic placebo ;starch, One capsule per day( Takgene Zist ) plus Vitamin D Capsule; 4000 IU ,One capsule per day. Control group: Inofolic Sachet; Inositol 2gr, twice a day plus Probiotic placebo; starch, One capsule per day plus Vitamin D placebo; Sunflower oil, One capsule per day for 8 weeks orally

Anti-Mullerian hormone, high-sensitivity C-reactive protein, Beck score

The people who entered the study based on the inclusion and exclusion criteria will be randomly assigned to one of the four control or intervention groups within each block using the random block method. The size of each block will be equal to four, eight or twelve samples, which will be applied to people based on a random permutation of treatments after completing each block. Blocks and permutations within each block will be created using the agricolae package in R software and using a specific seed.

Coding and similar packaging will be used for blinding. Therefore, the physician, patient, researcher and statistical analyzer are blind to the content of the packages. At the end of the study and analysis of data, decoding will be done.Another person at the clinic, who is not involved in the trial and not aware of assignments, will assign numbered bottles of capsules to the participants .Placebos capsules are completely identical with supplements in terms of their appearance, color, shape, size, and packaging.

Information is kept confidential.

Information about the main outcomes can be shared after the release of the results.

6 months after publishing the paper .

Researchers working in academic and research institutions.

Using data to complete further studies.

Dr Mohsen Taghizadeh, Kashan university of medical sciences

The data can be shared after the researcher's request and evaluating their research evidence.