A look into at-home fertility evaluations during the COVID-19 government mandated clinical closure
Karissa C Hammer1, Victoria Fruh2, Kelly Linden1, Shruthi Mahalingaiah1,2
1 Massachusetts General Hospital Fertility Center, Department of Obstetrics, Gynecology, and Reproductive Biology, Division of Reproductive Endocrinology and Infertility, Massachusetts General Hospital and Harvard Medical School 55 Fruit Street, Boston, MA, 02114, USA
2Department of Environmental Health, Harvard T.H. Chan School of Public Health, Boston, MA 02115, USA
At-home fertility testing started with the development of the urinary pregnancy test in the 1970s and has now evolved to include diagnostic and predictive tests1. Patients often report use of menstrual tracking phone apps and urinary ovulation predictor kits to their provider or are instructed to use these technologies by their physician2. Recently there has been a proliferation of advertised direct-to-consumer remote testing options for diagnostic testing or fertility optimization through companies such as Modern Fertility, Let’s Get Checked, Everlywell, and Dadi.3
Prior to the COVID-19 pandemic, much of fertility care required in-person visits for consultation, blood work, follow-up visits, exams and procedures. The need for at home serologic evaluation and telehealth visits became relevant during the COVID-19 pandemic as our fertility clinics and phlebotomy labs closed by government mandate. At the initial onset and first peak of the pandemic (SARS-coV-2) in March of 2020, American Society of Reproductive Medicine (ASRM) and European Society of Human Reproduction and Embryology (ESHRE) recommended cessation of fertility treatments in an effort to help stop the spread of the deadly coronavirus.4 Specifically ASRM guidance recommended “suspension of initiation of new treatment cycles, including ovulation induction, intrauterine insemination, retrievals and frozen embryo transfers, as well as non-urgent gamete cryopreservation” and also recommending “minimize in-person interactions and increase utilization of telehealth”. 5 A difficult but necessary decision was made to shut down in-person ambulatory visits in order to shift medical personnel, protect the supply of personalized protective equipment and create social distancing. 6,7 In an effort to continue care in an uninterrupted manner our clinic offered telehealth visits and a new option for at home serologic testing for fertility evaluations.
Our aim was to describe the demographic characteristics of those who utilized at-home serologic tests for fertility evaluation by a single fertility clinic during the COVID-19 government mandated clinical space closure.
A retrospective chart review of a single academic fertility center’s utilization of at home serologic fertility testing during the COVID-19 government mandated clinic closure was performed. Prior to the clinical space closure, no at-home serologic tests were offered or accepted as a form of evaluation by this clinic. Patients requiring fertility evaluation, including initial consultation via telehealth, blood work, or other clinical evaluation, during the clinical space closure period April 1, 2020 to May 25, 2020 were reviewed for documentation of being offered the option for at home fertility testing in a new patient visit or for required updated testing. Those who were offered the test were included in this descriptive study.
At home serology testing was performed via © Modern Fertility 8 for ovarian reserve (Anti-Mullerian hormone (AMH)), follicle stimulating hormone (FSH), estradiol (E2), luteinizing hormone (LH), thyroid-stimulating hormone (TSH), prolactin (PRL), and testosterone.9 These tests have been previously validated in a healthy population by the company and utilize U.S. Food and Drug Administration (FDA)–cleared Beckman-Coulter Access immunoassays.10 All patients offered testing required serologic evaluation for AMH, cycle day 3 hormone values (E2, FSH, LH), TSH, PRL. The at home test also reported testosterone levels, not required clinically but part of the at home test kit utilized. All at home tests were ordered through the same platform.
Testing was not covered by insurance during this time and was at a cost of $159 paid directly to the vendor by the patient. There was the option for the patient to use a health care spending account (HSA) or flexible spending account (FSA) for reimbursement of this fee.
We compared demographic data for patients who opted to complete at home testing to those who declined at home testing. The following demographic data was collected: patient age, insurance type (private vs public insurance), BMI (kg/m2), race, gravidity/parity and infertility diagnosis. A descriptive analysis was performed comparing those opted to complete at home fertility testing to those who declined. We report the descriptive data with means and standard deviations when able. No p-values are reported as no null hypothesis was proposed in this descriptive analysis.11-13
Patients with incomplete documentation or no documentation about at home fertility testing were excluded. IRB approval was obtained through Massachusetts General Hospital prior to conducting this study.
58 individuals were offered at home fertility testing during the clinic closure, of which 56 had full documentation. Of those offered and that ordered testing, 23 patients completed the at home test. Those who opted to complete at home testing were slightly older than those who declined, age 36.0 (SD 4.29) vs 34.78 (SD 3.87). Patients opting for at home testing were also more likely to have never been pregnant, 70% vs 56%, completed home testing vs declined at home testing. A majority of both groups were of normal BMI, non-Hispanic white, privately insured and had a fertility treatment in the past (Table 1).
Of the patients that completed at home testing, 17% (N=4) required repeat testing when the clinic re-opened. Given the low number we reviewed abnormal tests, we reviewed each independently. All four of the patients had an elevated TSH result with at home testing. Of the four patients, 50% had confirmed TSH elevations on repeat testing in the office setting and the other half had normalized values. One of the four patients also had an abnormally high prolactin level which was repeat with fasting in the clinical setting and the result was normal.
This descriptive review of uptake of at home fertility testing during government mandated clinical closure for the SARS-coV-2 pandemic highlights the potential patient interest and utility of at home testing. Even in a region of insurance mandated fertility coverage, 41% of patients offered at home testing still elected to use the test despite out-of-pocket cost of $159.8
Of those completing the at home testing, they tended to be only slightly older with a mean age of 36. This age does have increasing pressures on reproduction given its label as “advance maternal age” and the known correlation with age and declining female fertility.14,15 This may have played a factor in older women opting for at home testing during the clinic closure. The pandemic was likely another factor impacting our patients’ decision to utilize at home testing. Survey data collected by © Modern Fertility 2020 reported an increase in anxiety related to fertility during the COVID-19 pandemic: “61% reported an they’re more worried and anxious about their ability to have kids and family planning in general right now, and 31% said COVID-19 has changed their fertility or family planning decisions entirely.” 16 Bin-Kimhy et al conducted a survey study of 168 fertility patients during clinic closures, and found that at the time of the study 72% of participants wished to resume fertility treatments, demonstrating a desire to continue fertility treatments despite COVID-19 pandemic.17 Overall, we believe we had patient interest in completing the at home testing in an effort to continue their fertility treatment without delay during government mandated clinical closures.
This study is not a validity study for at home testing. However, we did not require repeat testing upon clinic space re-opening unless there was an abnormality. In the resulting patients above, repeat testing occurred mostly for TSH levels. The need for repeat testing is more likely a reflection of TSH variability because of difficulty measuring a glycosylated hormone.18-20 The company utilizes a FDA cleared Beckman-Coulter Access immunoassays to complete testing and validated venipuncture compared to fingerstick blood collection.10
Many clinics have now increased the utilization of telemedicine to provide initial consultations and follow up appointments to limit in person contact. This practice change decreases the number of contacts for both the patient and the provider, with the aim of reducing the possibility of spreading viral disease. Gynecologists are adapting to telemedicine and beginning to create standards of care for telemedicine treatment. 21,22 Fertility treatments are unique; there is a high burden on the patient for many in person evaluations for blood work, ultrasounds and procedures during their fertility workup and treatments. Telemedicine is one less appointment in person for these individuals. Could we also decrease contact by incorporating at home serologic tests?
In addition to pandemic-related changes in care delivery, at-home serologic testing could be incorporated into routine fertility care. Prior to receiving “in-cycle” treatments, patients require a pelvic ultrasound and uterine cavity evaluation. These two procedures require an in-person visit, but often are not timed on the same date as or early in the day for fasting blood work. A patient can opt to do blood work on the same day as these visits if it correlates appropriately with her menstrual cycle and is convenient; alternatively, she could complete her cycle day 3 blood work at home at a convenient time and schedule a single in person visit for ultrasound procedures. The ease of completing a test at home, especially one timed with the start of a menstrual cycle, allows a patient the ease to complete the test from wherever the patient is located without a last-minute appointment or commute.
This descriptive review has a limited number of patients and does not assess the validity of at home testing compared to clinic-offered laboratory testing within the context of an initial fertility evaluation. The retrospective nature of this review is also a limitation as we relied on the provider’s medical record, documentation about whether at home testing was offered. Incomplete documentation may have limited the number of patients within our analysis and may have led us to exclude patients who were only verbally offered the testing.
This study highlights an important future for our field: patient interest in at home serologic testing for fertility evaluation. We describe a single clinic’s uptake of at home testing utilized during government mandated clinical space closure. Although the COVID-19 pandemic was the reason for use of at home testing, perhaps it could become a standard option for patient evaluation after appropriate validation studies.
- The History of the Pregnancy Test. (Accessed 12/03/2020, at https://history.nih.gov/display/history/Pregnancy+Test+Timeline.)
- Johnson S, Stanford JB, Warren G, Bond S, Bench-Capon S, Zinaman MJ. Increased Likelihood of Pregnancy Using an App-Connected Ovulation Test System: A Randomized Controlled Trial. J Womens Health (Larchmt) 2020;29:84-90.
- The Best At-Home Fertility Tests of 2020. 2020. (Accessed Dec 3, 2020, at https://www.verywellfamily.com/best-at-home-fertility-tests-5080788.)
- Veiga A, Gianaroli L, Ory S, Horton M, Feinberg E, Penzias A. Assisted reproduction and COVID-19: A joint statement of ASRM, ESHRE and IFFS. Fertil Steril 2020;114:484-5.
- ASRM Press Release. ASRM Issues New Guidance on Fertility Care During COVID-19 Pandemic: Calls for Suspension of Most Treatments. 2020.
- David A, Zev R, Van Der Spuy Z, Diaz Yamal I, Committee for Reproductive Medicine EI. Reproductive health paradigms in times of COVID-19. Int J Gynaecol Obstet 2020;150:139-40.
- Dalton CB, Corbett SJ, Katelaris AL. COVID-19: implementing sustainable low cost physical distancing and enhanced hygiene. Med J Aust 2020;212:443-6 e1.
- Modern Fertility. © Modern Fertility 2020. 2020, at https://modernfertility.com.)
- Jones G, Carlton J, Weddell S, Johnson S, Ledger WL. Women's experiences of ovulation testing: a qualitative analysis. Reprod Health 2015;12:116.
- Burke EE, Beqaj S, Douglas NC, Luo R. Concordance of Fingerstick and Venipuncture Sampling for Fertility Hormones. Obstet Gynecol 2019;133:343-8.
- Greenland S, Senn SJ, Rothman KJ, et al. Statistical tests, P values, confidence intervals, and power: a guide to misinterpretations. Eur J Epidemiol 2016;31:337-50.
- Panagiotakos DB. Value of p-value in biomedical research. Open Cardiovasc Med J 2008;2:97-9.
- Dahiru T. P - value, a true test of statistical significance? A cautionary note. Ann Ib Postgrad Med 2008;6:21-6.
- Abdou CM. Age-Based Reproductive Healthcare Stereotype Threat (HCST) as a Stressor Affecting Prenatal Mental Health in Pregnant Women of Advanced Maternal Age: Measurement, Process, Outcomes, and Interactions with Ethnicity/Race, SES, and Other Social Identities. Curr Epidemiol Rep 2017;4:133-44.
- Artini PG, Obino ME, Vergine F, Sergiampietri C, Papini F, Cela V. Assisted reproductive technique in women of advanced fertility age. Minerva Ginecol 2018;70:738-49.
- Modern State of Fertility 2020: Career & Money. 2020. (Accessed February 22, 2021, 2021, at https://modernfertility.com/modern-state-fertility-2020-sofi-career-money.)Ben-Kimhy R, Youngster M, Medina-Artom TR, et al. Fertility patients under COVID-19: attitudes, perceptions and psychological reactions. Hum Reprod 2020;35:2774-83.
- Steele BW, Wang E, Klee GG, et al. Analytic bias of thyroid function tests: analysis of a College of American Pathologists fresh frozen serum pool by 3900 clinical laboratories. Arch Pathol Lab Med 2005;129:310-7.
- Donadio-Andrei S, Chikh K, Heuclin C, et al. Variability among TSH Measurements Can Be Reduced by Combining a Glycoengineered Calibrator to Epitope-Defined Immunoassays. Eur Thyroid J 2017;6:3-11.
- Samuels MH, Kolobova I, Smeraglio A, Niederhausen M, Janowsky JS, Schuff KG. Effect of Thyroid Function Variations Within the Laboratory Reference Range on Health Status, Mood, and Cognition in Levothyroxine-Treated Subjects. Thyroid 2016;26:1173-84.
- Green L, Fateen D, Gupta D, McHale T, Nelson T, Mishori R. Providing women's health care during COVID-19: Personal and professional challenges faced by health workers. Int J Gynaecol Obstet 2020.
- Veiga A, Gianaroli L, Ory S, Horton M, Feinberg E, Penzias A. Assisted reproduction and COVID-19: a joint statement of ASRM, ESHRE and IFFS. Hum Reprod Open 2020;2020:hoaa033.