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Effect of endometrial mechanical stimulation in an unselected population undergoing in vitro fertilization: futility analysis of a double-blind randomized controlled trial

  • Assisted Reproduction Technologies
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A Correction to this article was published on 17 May 2019

This article has been updated

Abstract

Purpose

Implantation failure is a major limiting factor of successful in vitro fertilization (IVF). The objective of this study was to determine if endometrial mechanical stimulation (EMS) by endometrial biopsy in the luteal phase of the cycle prior to embryo transfer (ET) improves clinical outcomes in an unselected subfertile population.

Methods

Double-blind, randomized controlled trial of EMS versus sham biopsy and odds of clinical pregnancy after IVF and embryo transfer. Secondary outcomes included spontaneous miscarriage and live birth.

Results

One hundred women enrolled and were randomized from 2013 to 2017. Enrollment was terminated after futility analysis showed no difference in clinical pregnancy between EMS versus control, 47.2% vs 61.7% (OR 0.55, 95% CI 0.25–1.23, p = 0.15). There were no significant differences between women who underwent EMS and those who did not in terms of positive pregnancy test 54.7% vs 63.8% (OR 0.69, 95% CI 0.31–1.53, p = 0.36), miscarriage 7.5% vs 2.1% (OR 3.76 95% CI 0.41–34.85, p = 0.22), or live birth 43.4% vs 61.7% (OR 0.48 95% CI 0.21–1.06, p = 0.07).

Conclusions

EMS in the luteal phase of the cycle preceding embryo transfer does not improve clinical outcomes in an unselected subfertile population and may result in a lower live birth rate. We caution the routine use of EMS in an unselected population.

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Change history

  • 17 May 2019

    The original version of this article unfortunately contained mistakes. The complete list of corrections is given below.

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Financial support

This study was financially supported by the following: 5T32HD055172-09 and UL1 TR002345.

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Authors and Affiliations

  1. Department of Obstetrics and Gynecology, Washington University School of Medicine, 4444 Forest Park Avenue, St. Louis, MO, 63108, USA

    Ashley M. Eskew, Lauren D. Reschke, Candice Woolfolk, Darcy E. Broughton, Patricia T. Jimenez, Kenan R. Omurtag, Sarah L. Keller, Valerie S. Ratts, Randall R. Odem & Emily S. Jungheim

  2. Reproductive Medical Associates of St. Louis, 641 N New Ballas, Creve Coeur, MO, 63141, USA

    Maureen B. Schulte

  3. Department of Obstetrics and Gynecology, Division of Reproductive Endocrinology and Infertility, Northwestern University, 259 E. Erie Street, Chicago, IL, 60611, USA

    Christina E. Boots

Authors
  1. Ashley M. Eskew
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  2. Lauren D. Reschke
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  3. Candice Woolfolk
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  4. Maureen B. Schulte
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  9. Sarah L. Keller
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Correspondence to Ashley M. Eskew.

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Eskew, A.M., Reschke, L.D., Woolfolk, C. et al. Effect of endometrial mechanical stimulation in an unselected population undergoing in vitro fertilization: futility analysis of a double-blind randomized controlled trial. J Assist Reprod Genet 36, 299–305 (2019). https://doi.org/10.1007/s10815-018-1356-5

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  • DOI: https://doi.org/10.1007/s10815-018-1356-5

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