Study of the effect of evening primrose oil supplementation on fertility outcomes in the women undergoing IVF treatment: A triple blind randomized controlled trial.

Determining the Effect of Evening Primrose Oil Supplementation on Fertility Outcomes in Infertile Women Treated with IVF

Controlled clinical trial, Phase 3, with two groups of parallel, triple-blind

Infertile women referred to Tabriz University of Medical Sciences Infertility Clinic who are candidates for IVF will be stratified based on definition of primary and secondary infertility. The stratification will be based on the proportion of clients (eg 1:1 or 1:2). The envelopes will be uniform, sealed, matte and will be prepared based on the sequence of assignment by the non-involved person. In the first five days of the menstrual IVF cycle, the envelopes No.1 will be given to the first person and this process will continue until the number of samples is completed.

Inclusion criteria: Women with primary and secondary infertility are candidates for IVF, 20-40 years, 18.5 < BMI < 29.9 Exclusion criteria: Follow a specific dietary pattern for medical or other reasons, Seizure history, Malignancy, Use of chemotherapy and radiotherapy, Continuous and daily consumption of herbal brews (Borage ...), Tobacco and alcohol or any substance abuse, IVF cycle ≥ 4, Use donated or frozen sperm or egg, Severe endometriosis, Having uterine anomalies, Use of blood thinners.

The intervention group will be given 42 capsules of 1000 mg Evening Primrose oil(containing 13% gammalinolenic acid and 72% linoleic acid) and control group placebo with the same shape and color.

Implantation rate, Fertility rate, Fetal quality status, Pregnancy test status, Side effects of Evening Primrose oil supplementation

Participants will be randomly assigned into two groups of recipients of evening primrose oil supplementation and placebo using random blocking method and blocks of size 4 and 6 using Random Allocation Software (RAS) with a 1: 1 assignment ratio by the person not involved in the research. To conceal the allocation, opaque envelopes with sample numbers will be provided and numbered. Preparation of envelopes and sequence generation will be done by a person not involved in the research. In the first five days of the IVF menstrual cycle, envelope No. 1 will be given to the first eligible person, and this process will continue until the number of samples is completed.

In this study, the drugs and the placebo will be prepared by the same pharmaceutical company in identical shape, color and smell. participants, researchers, medical staff (doctors, nurses, etc.) who are responsible for patient care, data collection officers and those who evaluate the outcome will not be informed about the drug type.