Rossi 2013.

Study characteristics
Methods	Study design: parallel‐group randomised controlled trial Setting: single centre/hospital Study duration: January 2005 to May 2009 Sample size calculation: no, sub‐analyses of larger trial
Participants	Number of participants randomised: 37 (subgroup of RCT in different populations); 21 in control, 16 in intervention Baseline characteristics (mean ± SD) Control: age 36.4 ± 3.4; lifestyle characteristics: 5/21 lifetime alcohol use/dependence, 0/21 current alcohol use/dependence, 1.8 drinks/drinking/d; fertility characteristics: not specified Intervention: age 34.9 ± 4.5; lifestyle characteristics: 7/16 lifetime alcohol use/dependence, 2/16 current alcohol use/dependence, 2.1 drinks/drinking/d; fertility characteristics: not specified Baseline differences: yes, control group (AO) had 1.8 drinks/drinking/d on average; intervention group (BI) had 2.1 drinks/drinking/d on average (no P value reported) Inclusion criteria: "women with infertility that practiced at‐risk drinking (at least 7 drinks/week or more than 3 drinks/1 d or T‐ACE‐positive). T‐ACE is a 4‐item screening questionnaire, validated in prenatal alcohol use studies, that asks about tolerance to alcohol, being annoyed by others’ comments about drinking, attempts to decrease use, and having a drink first thing in the morning (“eye‐opener”). As the number of previous IVF cycles influences cycle success, we included only each woman’s first IVF cycle with an embryo transfer" Exclusion criteria: "women with current treatment for alcohol or drug abuse, physical dependence on alcohol, or use of opiates, cocaine, or other illicit substances" Phase of fertility treatment: not specified (asked of study author but no reply received, probably before and during)
Interventions	Control: routine care + assessment Description: 1‐hour assessment interview by research assistants. Measures included (a) alcohol and drug abuse modules from the Structured Clinical Interview for DSM‐IV, to obtain current and lifetime alcohol and drug disorder diagnoses; (b) alcohol timeline follow‐back (TLFB), to obtain estimates of daily drinking for the 6 months before study enrolment; and (c) the Medical Outcomes Study 36‐Item Short Form Health Survey (SF‐36), to assess general health status, among others Intervention: alcohol Description: assessment (as described above) + an intervention using "Personal Steps to a Healthy Choice: A Woman’s Guide and Helping Patients Who Drink Too Much" with 3 follow‐up interviews. Assessment and feedback on individuals' drinking pattern and standardised information on health consequences of drinking + Goal setting and contracting (drinking goals and important reasons for modifying drinking behaviour) + Behavioral modification (identify circumstances individual would be at risk for drinking + develop alternative behaviours + written materials of "Personal steps" annotated with personal information Duration: 12 months. Frequency: multiple times, 1‐hour interview and assessment at baseline, at 3, 6, and 12 months Setting: individual Mode of delivery: F2F + written Integrity/Compliance: observation, practice with mock patients + audio tape and feedback on delivery of intervention
Outcomes	Live birth: number of live births, not clear when measured, 12 months? Miscarriage: pregnancy loss, defined as clinical pregnancy without live birth. Not clear when measured, 12 months? Reported behavioural changes in alcohol intake: decrease in number of drinks on a drinking day, decrease in % of drinking days in past 6 months, decrease in number of weeks drinking above SDL in past 6 months, decrease in number of binges in past 6 months measured at 12 months with alcohol timeline follow‐back questionnaire
Identification	Sponsorship source: National Institute on Alcohol Abuse and Alcoholism and Office of Research on Women's Health Protocol available/trial registration: NCT00846638 (not prospectively registered) Country: USA
Notes	Specific population (at‐risk drinkers on IVF) Corresponding author and other study authors contacted for clarification on participants, baseline data, outcomes (time point of live birth measured). No reply as of February 2021
Risk of bias
Bias	Authors' judgement	Support for judgement
Sequence generation	Low risk	Quote: "computer‐generated random assignment list"
Allocation concealment	Unclear risk	Comment: computer‐generated random assignment list. No information on allocation concealment. Study authors were contacted twice, with no reply as of February 2021
Blinding of participants and personnel All outcomes	High risk	Quote: "the participants and the study staff could not be blinded to treatment group assignment, similar to other studies taking place in medical settings (Saitz et al., 2007)" 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	Comment: outcome assessors were not blinded. Live birth and miscarriage were not likely to be influenced, as they are observer‐reported outcomes not involving judgement
Blinding of outcome assessors Patient reported outcome measures	High risk	Comment: outcome assessor is participant and is not blinded; reported behavioural changes regarding drinking are likely to be influenced, as less drinking is known to be socially desirable
Incomplete outcome data	High risk	Comment: in Chang 2011 (table 2), 161 out of 511 participants randomised are reported to have infertility. However outcome data are available only for 37 participants. Study authors were contacted twice for clarification, but no reply was received as of February 2021
Selective outcome reporting	High risk	Comment: study protocol not prospectively registered. Subgroup analysis (on population with infertility) not pre‐specified in the study protocol. Baseline for several alcohol use outcomes not reported, although this information should be available. Pre‐specified outcome: SF‐36 data not reported
Other sources of bias	Low risk	Comment: study appears free of other sources of bias

BMI: body mass index.

DRS: dietary risk score.

F2F: face‐to‐face.

FFQ: Food Frequency Questionnaire.

ICSI: intracytoplasmic sperm injection.

IQR: interquartile ratio.

ITM: Iranian Traditional Medicine.

ITT: intention‐to‐treat.

IUI: intrauterine insemination.

IVF: in vitro fertilisation.

LRS: lifestyle risk score.

MVPA: moderate to vigorous physical activity.

PCOS: polycystic ovarian syndrome.

QOL: quality of life.

RCT: randomised controlled trial.

SD: standard deviation.

SDL: sensible drinking limit.

SF‐36: 36‐Item Short Form Health Survey.

SQUASH: Short Questionnaire to Assess Health‐Enhancing Physical Activity.

TLFB: timeline follow‐back.

WHO: World Health Organization.