Alibeigi 2020.

Study characteristics
Methods	Study design: parallel‐group randomised controlled trial Setting: single centre/hospital Study duration: enrolment April 2017 to November 2017 + 3 months' follow‐up; no further details Sample size calculation: yes: "the sample size was calculated using a significance level of 0.05 and a power of 80% to detect at least a difference of 25% between groups in 1 outcome of the study for the baseline success rate of 30%. The sample size consisted of 62 patients in each group. Due to the prediction of a high dropout rate during the study, we assumed a sample size of 90 patients per group and 180 patients were randomised"
Participants	Number of participants randomised: 180; 89 in control, 91 in intervention Baseline characteristics (mean ± SD) Control: age: 30.0 ± 4.7; lifestyle characteristics: BMI: 25.4 ± 4.4; fertility characteristics: IVF treatment duration (years): 5.1 ± 3.1, previous IVF attempts: 0.19 ± 0.50 Intervention: age: 30.0 ± 4.2; lifestyle characteristics: BMI: 25.0 ± 4.4; fertility characteristics: IVF treatment duration (years): 4.7 ± 2.4, previous IVF attempts: 0.39 ± 0.67 Baseline differences: yes, differences in in previous IVF attempts (P = 0.029) and differences in education level (P = 0.004) between control and intervention (intervention group had more previous IVF attempts and was better educated) Inclusion criteria: women with infertility with ovulatory problems or endometriosis or idiopathic infertility, age 20 to 40 years Exclusion criteria: Infertility due to anatomical causes, with sterility of husbands, with uterine myoma or hydrosalpinx, smoking, drinking alcohol, diabetes mellitus, lack of interest or cooperation during the study, or refusal to go through IVF/ICSI Phase of fertility treatment: during treatment ("study continued until ongoing IVFs lasted at least 3 months")
Interventions	Control: routine care + unstructured minimal preconception lifestyle advice Description: routine health care and modern dietary recommendations provided every 2 weeks by telephone and once a month face‐to‐face (F2F) Intervention: combination: diet + general healthy lifestyle recommendations Description: traditional medicine‐oriented diet regimen and general healthy lifestyle recommendations Traditional medicine–oriented diet regimen: list of recommended and forbidden foods for women with infertility based on literature review and considering the eating habits of people, availability of foods, and traditional healthcare recommendations. Recommended foods: warm and nutritious foods including lamb, chicken, quail, shrimps, fish (limited amount), rice, chickpeas, beans, barley, wheat, bread, milk, honey, eggs, olive oil, animal butter, pomegranate sauce, cinnamon, saffron, and cloves. It was also recommended that patients consume cooked vegetables such as onions, garlic, apples, carrots, acanthus, pumpkin, and okra. Forbidden foods: cold or sour foods, foods that produce melancholic sputum, nutrients that weaken some main organs, doughy foods or foods that are dense or viscous and produce unhealthy and dense humor, heavy and hard digestion foods, ice with water General healthy lifestyle recommendations: 6 essential principles of health according to ITM sources: avoiding polluted air, sleeping adequately and at the right times, having physical activity, controlling stress and mental status, properly disposing of waste materials of the body, and observing the etiquette of proper eating and drinking. Also, chewing food well, avoiding overeating, not eating several foods in a meal (no food mixing), not drinking liquids with or immediately after food, and not eating harmful foods including fast foods, canned foods, foods with preservatives, hard‐digestible foods, ice water, sour foods, and drinks are of paramount importance in ITM Duration: "study continued until ongoing IVFs lasted at least 3 months" Frequency: multiple contacts, follow‐up every 2 weeks by telephone, once a month face‐to‐face Setting: individual + group discussion Mode of delivery: F2F + written training guidance text for self‐learning + follow‐up via phone and telegram discussion group Integrity/Compliance: "the individuals in the intervention group were carefully followed, and the rate and quality of their diets were checked based on a 24h recall questionnaire which was completed at 3 different times every 2 weeks." Data were not reported
Outcomes	Reported behavioural changes in weight: BMI in kg/m² measured at baseline and "after the study" Clinical pregnancy: defined as pregnancy from IUI, IVF, or spontaneous pregnancy measured with sonography; no further details specified
Identification	Sponsorship source: grant from the Research and Technology Deputy of the Iran University of Medical Sciences Protocol available/trial registration: IRCT2017013032245N2 Country: Iran
Notes	Clinical pregnancy split into IUI, IVF, and spontaneous. Information regarding diet behaviour (adherence to intervention) measured (qualitatively) but not reported Study authors contacted twice for clarification regarding allocation concealment, interventions, and outcomes (diet behaviour, definition and time point of clinical pregnancy, and time point of BMI assessment). No reply as of February 2021
Risk of bias
Bias	Authors' judgement	Support for judgement
Sequence generation	Unclear risk	Quote: "randomization was stratified according to age groups. According to the order of entrance to the study, based on permuted blocks of size four, the patients in each of the 4 age groups of < 30, 30–34, 35–37, and 38–40 years were randomly assigned to the intervention and control groups" Comment: study authors stated that block randomisation was used, but the process of selecting the blocks was not specified. Study authors were contacted twice for clarification; no reply as of February 2021
Allocation concealment	Unclear risk	Quote: "the random allocation sequence was generated by an investigator who was not involved in eliciting data or conducting the study" Comment: not clear how allocation was concealed. Study authors were contacted twice; no reply as of February 2021
Blinding of participants and personnel All outcomes	High risk	Quote: "another limitation of our study was the lack of blinding patients and physicians in our study" Comment: participants and personnel were aware of assigned intervention. Deviations from the intended intervention could have occurred
Blinding of outcome assessors Objective outcomes	Low risk	Quote: "however, all outcomes were measured based on clinical tests. They were all objective and quantitative not qualitative, so they could not be biased"
Blinding of outcome assessors Patient reported outcome measures	Unclear risk	Comment: outcome assessors were not blinded. BMI and clinical pregnancy were not likely to be influenced, as they are observer‐reported outcomes not involving judgement
Incomplete outcome data	Low risk	Quote: "the study flowchart for IVF is shown in Figure 1. Five women in the intervention group and 6 women in the control group were excluded due to lack of willingness and cooperation. Their data were used to assess the outcome of spontaneous pregnancy, but spontaneous pregnancies did not occur to them" Comment: ITT analysis. Outcome data were available for nearly all participants randomised. Missing data were documented and balanced per group. However, reasons for lack of willingness and cooperation were not reported in detail
Selective outcome reporting	High risk	Comment: prospectively registered study protocol was available. Most outcomes were analysed and reported in accordance with the protocol. Change in dietary behaviour and adherence to intervention were measured but not reported. Live birth or ongoing pregnancy was not included in the protocol and was not reported. Study authors were contacted twice for clarification; no reply as of February 2021
Other sources of bias	Low risk	Comment: study appears free of other sources of bias