The Ovulation and Menstruation Health study website consists of a short animated educational recruitment video, a web-based consent form, screening questions, and a survey instrument. The animated video was designed to appeal to a diverse audience, as its illustrations included women of all races and body types. The goal of the Ovulation and Menstruation Health Pilot Study was to recruit at least 200 reproductive-aged women over a 1-year period. Those who were menstruating or had the capacity to menstruate were eligible (trans-male and other). Individuals who were <18 years or >45 years of age; identified as male; were pregnant at the time of the survey; had a hysterectomy/oophorectomy, amenorrhea due to radiation, or chemotherapy; or were unwilling or unable to provide an email address were deemed ineligible. The survey instrument was publicly accessible from August 21, 2017 to February 26, 2018 on the study website and was used in each recruitment modality. The Boston Medical Center and Boston University Medical Campus Institutional Review Boards approved the study (IRB H-35075).

The first 200 participants who completed the survey were entered into a lottery for a US $200 gift card. All who were approached for recruitment were offered free earphones.

The multimodal recruitment locations were in clinic, a Boston-based community event, and the internet. The recruitment approach was adapted to meet the needs of each recruitment location.

The web-based consent form included questions on a participant’s interest in follow-up surveys, other studies, and contributing biospecimens. Once consented, the individual was presented with an eligibility screener. Eligible participants recruited in clinic were able to start the survey in the waiting room. For eligible participants from the community event and the internet, a unique link to the survey was emailed to the participant’s email address. For all enrolled participants, up to 3 reminders were sent on consecutive days to those who did not complete the survey.

The Ovulation and Menstruation Health Pilot Study survey had a total of 10 sections, with 219 questions; however, most respondents had fewer questions due to skip patterns. The About You section included questions on current residence and whether they ever received care at BMC. The Demographics section included questions on race and ethnicity, education, birth country, and income. The Anthropometrics section captured data regarding height, weight, and body shape using a pictorial tool. The Menstrual Cycle section asked about menarche, regularity of cycles, and cycle tracking. The Hormone Usage section obtained data on hormonal contraceptive usage, history and reasons for hormone usage. The Health and Body section included questions for self-reported androgen excess using a pictorial tool for androgenic alopecia and hirsutism based on the modified Ferriman-Gallwey scale [22]; polycystic ovary syndrome status (questions specific to polycystic ovary syndrome diagnosis, symptoms for diagnosis, and medication and supplement use, and family history of polycystic ovary syndrome); reproductive health (history of infertility, uterine fibroids, endometriosis, and premature ovarian failure); general health (diagnosed medical conditions such as hypertension, diabetes, and other chronic conditions and their treatment); diet and lifestyle (limited questions about alcoholic, nonalcoholic beverage consumption, and smoking habits); obstetric history (ever pregnant, number of prior pregnancies, and each pregnancy outcome, including stillbirths and miscarriages, and live births). For every livebirth, an additional question was asked regarding gestational length and birth outcomes such as birth weight. Study data were recorded and stored on encrypted servers at the Boston University School of Public Health Biostatistics & Epidemiology Data Analytics Center. The Ovulation and Menstruation Health Pilot Study survey can be found on the Harvard Dataverse [23].

Participant characteristics were evaluated by recruitment location and survey completion. Those who started the survey via the internet included those who input the link into their web-browser after learning of the study from any web-based or printed recruitment materials and completed the web-based consent and screener. Survey initiation was defined as anyone who started the “About You” section. Survey completion was defined as having completed the first question of the “Pregnancy and Birth History” upon entering the total number of pregnancies experienced. Those who entered 0 pregnancies had no further questions to complete. Those who entered 1 or more had additional pregnancy related questions to complete. For both nulliparous and multiparous responses, completing the survey was as entering the total number of pregnancies experienced. To assess the geographical catchment area associated with the survey, participants’ self-reported home states were mapped.

Recruitment exceeded our target of 200 women in 8 weeks. During the 6-month recruitment window, 438 women began the consent process, 384 were assessed for eligibility, and 345 women were screened and included (88.7% of those assessed for eligibility). Of the 345, 278 women started the survey, of whom 66 were recruited in clinic, 61 were recruited from the community event, and 174 were recruited from the internet. Figure 1 displays the study enrollment flow chart. Spikes in cumulative enrollment coincided with the active in-clinic recruitment and the community event (Figure 2). Out of the 384 participants who consented and completed screening, only 39 (10.2%) were excluded. Of the individuals who were excluded, 18 were no longer menstruating, 16 were unwilling or unable to provide email addresses, and 5 were over the age of 45 years. Among those who initiated the survey and responded to re-contact questions, agreement for re-contact was high—96.0% (266/277) consented to be re-contacted for additional information, 81.2% (225/277) for biological samples, 96.4% (267/277) for a follow-up survey, and 79.4% (220/277) for a different research study.

Among the 278 women who started the survey, the average age was 27.3 years and the median age was 25.0 (SD 6.0), with the majority (224/273, 82.1%) born in the United States (Table 1). Participants were White (176/272, 64.7%), Black/African American (32/272, 11.8%), Latina/Hispanic (21/272, 7.7%), and mixed race (27/272, 9.9%). Two individuals identified their gender as other (nonbinary or gender queer). While the majority (216/271, 79.7%) had a 4-year college degree or more, 7.0% (19/271) had a high school degree or less education. Participants were distributed across all income categories, with 21.3% (58/272) in the less than $25,000 category. The mean BMI was 26.1 kg/m² (SD 6.6), with 15.4% (41/266) in the overweight category; 13.1% (32/245) had smoked at least 100 cigarettes over their lifetime. The reported prevalence of doctor-diagnosed polycystic ovary syndrome was 14.6% (37/254), and 82.3% (218/265) had ever used hormonal contraception. The geographic distribution of the cohort included 20 states (Figure 3). The majority of the participants were recruited from Massachusetts (n=173) and Missouri (n=50).

Differences were found in age, birth country, race, educational attainment, BMI, and physician-diagnosed polycystic ovary syndrome, by location of recruitment (Table 2). Women recruited in clinic tended to be older (median 34.0 years, SD 6.7), born outside the US (26/42, 61.9%), and with lower educational attainment, 19.0% (8/42) were high school graduate/GED or less education compared to women recruited at the community fair and via the internet. Women recruited in clinic were also more likely to be obese (18/38, 47.4%), have had a physician diagnosis of polycystic ovary syndrome (12/33, 36.4%), and less likely to have ever used oral contraceptives (23/37, 62.2%) compared to women recruited at the community fair and via the internet. Those from the community fair and internet were more likely to be born in the US (58/61, 95.1% and 150/170, 88.2%, respectively), White (47/61, 77.0% and 121/169, 71.6%, respectively), and have greater than a 4-year college degree (24/61, 39.3% and 83/168, 49.4%, respectively) than those recruited from the clinic. Women recruited from outside the clinic were younger (community fair: median 23.0, SD 4.0; internet: median 25.0, SD 5.4 years), leaner BMI (community fair: 23.3 kg/m² SD 4.8; internet: 23.5 kg/m² SD 7.0) and had a lower prevalence of physician diagnosed polycystic ovary syndrome (community fair: 3/61, 4.9%; internet: 22/160, 13.8%). Of note, 46.4% of women recruited in clinic (13/28) had been pregnant compared to 3.3% (2/61) and 17.0% (27/159) for the community fair and internet participants, respectively. Income and smoking status were similar among recruitment locations.

Among the 278 women who started the survey, 247 (88.8%) completed it. The median time to completion was 12.6 minutes (range 1.03 minutes to 92 days); 7 participants took more than 24 hours to complete the survey. Women completing the survey were more likely to be US born (210/246, 85.4% vs 14/27, 51.9%), White (165/245, 67.3% vs 11/27, 40.7%) and have 4 years of college education or more (200/244, 81.9% vs 16/27, 59.2%) compared to those who did not complete the survey (Table 3).

We also found that the women who did not complete the survey were older and had higher annual household income compared to those who completed the survey. Among the 31 women who did not complete the survey, dropout seemed equally distributed across section categories (Figure 4).