Virtual Compared With In-Clinic Transvaginal Ultrasonography for Ovarian Reserve Assessment

Esther H Chung, Laura C Petishnok, Jesse M Conyers, David A Schimer, Wendy S Vitek, Amy L Harris, Michelle A Brown, Julie A Jolin, Anatte Karmon, Aaron K Styer, Esther H Chung, Laura C Petishnok, Jesse M Conyers, David A Schimer, Wendy S Vitek, Amy L Harris, Michelle A Brown, Julie A Jolin, Anatte Karmon, Aaron K Styer

Abstract

Objective: To evaluate noninferiority of virtual transvaginal ultrasonography compared with in-clinic ultrasonography for ovarian reserve assessment.

Methods: We conducted a single-site, head-to-head crossover trial. Participants performed self-administered virtual transvaginal ultrasonography at home, guided by a remote-certified ultrasound technologist, then underwent transvaginal ultrasonography in-clinic with another ultrasound technologist. Participants were women in the greater Boston area interested in evaluating ovarian reserve and recruited through social media, health care referrals, and professional networks. The uterus and ovaries were captured in sagittal and transverse views. These randomized recordings were reviewed by two or three independent, blinded reproductive endocrinologists. The primary outcome was noninferiority of the rate of clinical quality imaging produced at home compared with in clinic. Sample size was selected for greater than 90% power, given the 18% noninferiority margin. Secondary outcomes included antral follicle count equivalency and net promoter score superiority.

Results: Fifty-six women were enrolled from December 2020 to May 2021. Participants varied in age (19-35 years), BMI (19.5-33.9), and occupation. Ninety-six percent of virtual and 98% of in-clinic images met "clinical quality." The difference of -2.4% (97.5% CI lower bound -5.5%) was within the noninferiority margin (18%). Antral follicle counts were equivalent across settings, with a difference in follicles (0.23, 95% CI -0.36 to 0.82) within the equivalence margin (2.65). Virtual examinations had superior net promoter scores (58.1 points, 97.5% CI of difference 37.3-79.0, P<.01), indicating greater satisfaction with the virtual experience.

Conclusion: Virtual transvaginal ultrasonography remotely guided by an ultrasonography technologist is noninferior to in-clinic transvaginal ultrasonography for producing clinical quality images and is equivalent for estimating antral follicle count. Virtual transvaginal ultrasonography had superior patient satisfaction and has potential to significantly expand patient access to fertility care.

Funding source: This study was sponsored by Turtle Health.

Clinical trial registration: ClinicalTrials.gov, NCT04687189.

Conflict of interest statement

Financial Disclosure: The authors Esther H. Chung, Laura C. Petishnok, Jesse M. Conyers, David A. Schimer, Wendy S. Vitek, Amy L. Harris, Michelle A. Brown, Julie A. Jolin, Anatte Karmon and Aaron K. Styer are paid consultants and advisors of Turtle Health. None hold equity or options in the Company. The other authors did not report any potential conflicts of interest.

Copyright © 2022 The Author(s). Published by Wolters Kluwer Health, Inc.

Figures

Fig. 1.. Representative image panel of virtual…
Fig. 1.. Representative image panel of virtual and in-clinic cine clips of the right ovary, left ovary, and uterus.
Chung. Virtual vs in-Clinic Transvaginal Ultrasonography. Obstet Gynecol 2022.
Fig. 2.. Noninferiority of clinical quality rates…
Fig. 2.. Noninferiority of clinical quality rates of virtual vs in-clinic scans.
Chung. Virtual vs in-Clinic Transvaginal Ultrasonography. Obstet Gynecol 2022.

References

    1. Centers for Disease Control and Prevention. Reproductive health: infertility FAQs. Accessed March 23, 2020.
    1. Lampic C, Svanberg AS, Karlström P, Tydén T. Fertility awareness, intentions concerning childbearing, and attitudes towards parenthood among female and male academics. Hum Reprod 2006;21:558–64. doi: 10.1093/HUMREP/DEI367
    1. CB Insights. The body series: how technology is transforming women’s healthcare. Accessed August 23, 2021.
    1. Kyweluk M, Feinberg EC. Direct-to-consumer (DTC) ovarian reserve testing benefits the company, not the consumer. Accessed August 23, 2021.
    1. Kyweluk MA. Quantifying fertility? Direct-to-consumer ovarian reserve testing and the new (in)fertility pipeline. Soc Sci Med 2020;245:112697. doi: 10.1016/J.SOCSCIMED.2019.112697
    1. Yeh PT, Kennedy CE, Van der Poel S, Matsaseng T, Bernard L, Narasimhan M. Should home-based ovulation predictor kits be offered as an additional approach for fertility management for women and couples desiring pregnancy? A systematic review and meta-analysis. BMJ Glob Heal 2019;4:e001403. doi: 10.1136/BMJGH-2019-001403
    1. Amanvermez R, Tosun M. An update on ovarian aging and ovarian reserve tests. Int J Fertil Steril 2016;9:411. doi: 10.22074/IJFS.2015.4591
    1. Testing and interpreting measures of ovarian reserve: a committee opinion. Fertil Steril 2015;103:e9–17. doi: 10.1016/J.FERTNSTERT.2014.12.093
    1. Ulrich ND, Marsh EE. Ovarian reserve testing: a review of the options, their applications, and their limitations. Clin Obstet Gynecol 2019;62:228. doi: 10.1097/GRF.0000000000000445
    1. Sabek EAS, Saleh OI, Ahmed HA. Ultrasound in evaluating ovarian reserve, is it reliable? Egypt J Radiol Nucl Med 2015;46:1343–8. doi: 10.1016/J.EJRNM.2015.08.008
    1. Kannamannadiar J, Campbell B, Hopkisson J, Clewes J, Johnson I, Raine-Fenning N. Establishing the intercycle variability of three-dimensional ultrasonographic predictors of ovarian reserve. Fertil Steril 2008;90:2126–32. doi: 10.1016/J.FERTNSTERT.2007.10.028
    1. Fleming R, Seifer DB, Frattarelli JL, Ruman J. Assessing ovarian response: antral follicle count versus anti-Müllerian hormone. Reprod Biomed Online 2015;31:486–96. doi: 10.1016/J.RBMO.2015.06.015
    1. Tal R, Seifer DB. Ovarian reserve testing: a user's guide. Am J Obstet Gynecol 2017;217:129–40. doi: 10.1016/J.AJOG.2017.02.027
    1. Modern Fertility. Clinical study: reliable, easy testing for fertility hormones. Accessed August 23, 2021.
    1. Brezina PR, Haberl E, Wallach E. At home testing: optimizing management for the infertility physician. Fertil Steril 2011;95:1867–78. doi: 10.1016/J.FERTNSTERT.2011.01.001
    1. Steiner AZ, Pritchard D, Stanczyk FZ, Kesner JS, Meadows JW, Herring AH, et al. Association between biomarkers of ovarian reserve and infertility among older women of reproductive age. JAMA 2017;318:1367–76. doi: 10.1001/JAMA.2017.14588
    1. U.S. Food and Drug Administration. Non-inferiority clinical trials. Accessed August 23, 2021.
    1. Advarra. Accessed August 23, 2021.
    1. . Sonograms Enable Looking Forward - Home Examinations Led by Providers validation study (SELF-HELP). Accessed August 23, 2021.
    1. Liu J, Hsueh H, Hsieh E, Chen JJ. Tests for equivalence or non-inferiority for paired binary data. Stat Med 2002;21:231–45. doi: 10.1002/SIM.1012.
    1. Clarius. About us.Accessed August 23, 2021.
    1. U.S. Food and Drug Administration. Avoid fetal “keepsake” images, heartbeat monitors. Accessed November 19, 2021.
    1. Le Lous M, De Chanaud N, Bourret A, Senat MV, Colmant C, Jaury P, et al. Improving the quality of transvaginal ultrasound scan by simulation training for general practice residents. Adv Simul (Lond) 2017;2:24. doi: 10.1186/s41077-017-0056-z
    1. Salomon LJ, Nassar M, Bernard JP, Ville Y, Fauconnier A. A score-based method to improve the quality of emergency gynaecological ultrasound examination. Eur J Obstet Gynecol Reprod Biol 2009;143:116–20. doi: 10.1016/J.EJOGRB.2008.12.003
    1. Jin BB, Gong YZ, Ma Y, He ZH. Gynecological emergency ultrasound in daytime and at night: differences that cannot be ignored. Ther Clin Risk Manag 2018;14:1141–7. doi: 10.2147/TCRM.S169165
    1. Hausleiter J, Martinoff S, Hadamitzky M, Martuscelli E, Pschierer I, Feuchtner GM, et al. Image quality and radiation exposure with a low tube voltage protocol for coronary CT angiography results of the PROTECTION II trial. JACC Cardiovasc Imaging 2010;3:1113–23. doi: 10.1016/J.JCMG.2010.08.016
    1. Qualtrics. What is NPS? Your ultimate guide to net promoter score. Accessed August 23, 2021.
    1. Hamilton DF, Lane JV, Gaston P, Patton JT, Macdonald DJ, Simpson AH, et al. Assessing treatment outcomes using a single question: the net promoter score. Bone Joint J 2014;96-B:622–8. doi: 10.1302/0301-620X.96B5.32434
    1. Retently. What is a good net promoter score? (2021 NPS benchmark). Accessed August 23, 2021.
    1. Krol M, de Boer D, Delnoij D, Rademakers J. The Net Promoter Score--an asset to patient experience surveys? Health Expect 2015;18:3099–109. doi: 10.1111/HEX.12297
    1. Reichheld FF. The one number you need to grow. Harv Bus Rev December 81:46–54.
    1. Koladycz R, Fernandez G, Gray K, Marriott H. The net promoter score (NPS) for insight into client experiences in sexual and reproductive health clinics. Glob Heal Sci Pract 2018;6:413–24. doi: 10.9745/GHSP-D-18-00068
    1. Ahn S, Park S, Lee K. How to demonstrate similarity by using noninferiority and equivalence statistical testing in radiology research. Radiology 2013;267:328–38. doi: 10.1148/RADIOL.12120725
    1. Mara M, Horak P, Kubinova K, Dundr P, Belsan T, Kuzel D. Hysteroscopy after uterine fibroid embolization: evaluation of intrauterine findings in 127 patients. J Obstet Gynaecol Res 2012;38:823–31. doi: 10.1111/J.1447-0756.2011.01782.X
    1. DJS. A comparison of the two one-sided tests procedure and the power approach for assessing the equivalence of average bioavailability. J Pharmacokinet Biopharm 1987;15:657–80. doi: 10.1007/BF01068419
    1. Shrout PE, Fleiss JL. Intraclass correlations: uses in assessing rater reliability. Psychol Bull 1979;86:420–8. doi: 10.1037/0033-2909.86.2.420
    1. van Disseldorp J, Lambalk CB, Kwee J, Looman CW, Eijkemans MJ, Fauser BC, et al. Comparison of inter- and intra-cycle variability of anti-Müllerian hormone and antral follicle counts. Hum Reprod 2010;25:221–7. doi: 10.1093/HUMREP/DEP366
    1. Subirá J, Alberola-Rubio J, Núñez M, Escrivá AM, Pellicer A, Montañana V, et al. Inter-cycle and inter-observer variability of the antral follicle count in routine clinical practice. Gynecol Endocrinol 2017;33:515–18. doi: 10.1080/09513590.2017.1291614
    1. K192107-Prithul Bom. Accessed August 23, 2021.
    1. Instructions for authors—July 2021. Obstet Gynecol 2021;138:138–55. doi: 10.1097/AOG.0000000000003955
    1. Baruch Y, Holtom BC. Survey response rate levels and trends in organizational research. 2008;61:1139–60. doi: 10.1177/0018726708094863
    1. Guy R, King E, Ayers A. The role of transvaginal ultrasound in the assessment of the female pelvis. Clin Radiol 1988;39:669–72. doi: 10.1016/S0009-9260(88)80090-4
    1. Lefringhouse JR, Neward E, Ueland FR, Baldwin LA, Miller RW, DeSimone CP, et al. Probability of fallopian tube and ovarian detection with transvaginal ultrasonography in normal women. Womens Health (Lond) 2016;12:303–11. doi: 10.2217/WHE.15.111
    1. Glanc P, Brofman N, Kornecki A, Abrams J, Farine D, Salem S. Visualization of the ovaries in early pregnancy by transvaginal sonography. J Obstet Gynaecol Can 2007;29:228–31. doi: 10.1016/S1701-2163(16)32415-X
    1. Evans KD. Performance evaluation for the sonographer. 2016;9:143–6. doi: 10.1177/875647939300900307
    1. Van Doorn LC, Dijkhuizen FP, Kruitwagen RF, Heintz AP, Kooi GS, Mol BW. Accuracy of transvaginal ultrasonography in diabetic or obese women with postmenopausal bleeding. Obstet Gynecol 2004;104:571–8. doi: 10.1097/01.AOG.0000136080.55874.7F
    1. Malhotra N, Bahadur A, Singh N, Kalaivani M, Mittal S. Does obesity compromise ovarian reserve markers? A clinician's perspective. Arch Gynecol Obstet 2013;287:161–6. doi: 10.1007/S00404-012-2528-7
    1. Halawaty S, ElKattan E, Azab H, ElGhamry N, Al-Inany H. Effect of obesity on parameters of ovarian reserve in premenopausal women. J Obstet Gynaecol Can 2010;32:687–90. doi: 10.1016/S1701-2163(16)34573-X
    1. Melissant HC, Verdonck-de Leeuw IM, Lissenberg-Witte BI, Konings IR, Cuijpers P, Van Uden-Kraan CF. ‘Oncokompas,’ A web-based self-management application to support patient activation and optimal supportive care: a feasibility study among breast cancer survivors. Acta Oncol 2018;57:924–34. doi: 10.1080/0284186X.2018.1438654
    1. Ethics Committee of the American Society for Reproductive Medicine. Disparities in access to effective treatment for infertility in the United States: an Ethics Committee opinion. Fertil Steril 2015;104:1104–10. doi: 10.1016/J.FERTNSTERT.2015.07.1139
    1. Reindollar RH. Increasing access to infertility care-what will it take? Fertil Steril 2017;108:600–1. doi: 10.1016/J.FERTNSTERT.2017.09.002
    1. The use of antimüllerian hormone in women not seeking fertility care. ACOG Committee Opinion No. 773. American College of Obstetricians and Gynecologists. Obstet Gynecol 2019;133:e274–8. doi: 10.1097/AOG.0000000000003162

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