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Human growth hormone for poor responders: a randomized placebo-controlled trial provides no evidence for improved live birth rate

  • Robert J. Norman
    Correspondence
    Corresponding author.
    Affiliations
    University of Adelaide, Robinson Research Institute, North Adelaide, SA 5006, Australia

    , Fertility SA, 431 King William Road, Adelaide, SA 5000, Australia
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  • Helen Alvino
    Affiliations
    University of Adelaide, Robinson Research Institute, North Adelaide, SA 5006, Australia
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  • Louise M. Hull
    Affiliations
    University of Adelaide, Robinson Research Institute, North Adelaide, SA 5006, Australia
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  • Ben W. Mol
    Affiliations
    University of Adelaide, Robinson Research Institute, North Adelaide, SA 5006, Australia

    South Australian Health and Medical Research Institute, Robinson Research Institute, North Adelaide, SA 5006; Monash University, Clayton, VIC 3800, Australia
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  • Roger J. Hart
    Affiliations
    Fertility Specialists of Western Australia, Claremont, WA 6010; The University of Western Australia, Crawley, WA 6009, Australia
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  • Thu-Lan Kelly
    Affiliations
    Adelaide Health Technology Assessment, School of Public Health, The University of Adelaide, Adelaide, SA 5006; Quality Use of Medicines Pharmacy Research Centre, University of South Australia, Adelaide, SA 5001, Australia
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  • Luk Rombauts
    Affiliations
    Monash IVF, Monash Surgical Private Hospital, Clayton, VIC 3168, Australia
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  • on behalf of theLIGHT investigators
    Author Footnotes
    1# LIGHT investigators: Richard Henshaw (Repromed), Mark Bowman (Genea), Howard Smith (Westmead Fertility), Peter Illingworth and William Ledger (IVF Australia), Lyndon Hales (Melbourne IVF), Mary Birdsall (Fertility Associates), John Yovich (Pivet).
  • Author Footnotes
    1# LIGHT investigators: Richard Henshaw (Repromed), Mark Bowman (Genea), Howard Smith (Westmead Fertility), Peter Illingworth and William Ledger (IVF Australia), Lyndon Hales (Melbourne IVF), Mary Birdsall (Fertility Associates), John Yovich (Pivet).
Published:February 26, 2019DOI:https://doi.org/10.1016/j.rbmo.2019.02.003

      Abstract

      Research question

      Does the addition of human growth hormone (HGH) to an IVF cycle improve the live birth rate in previously documented poor responders to FSH?

      Design

      Double-blind, placebo-controlled, randomized clinical trial comparing HGH to placebo in maximal stimulation in an IVF cycle. The study was stopped after 4 years. Women receiving ovarian stimulation in one IVF cycle, having failed to produce more than 5 eggs in a previous cycle with more than 250 IU/day of FSH were included. Basal FSH was ≤15 IU/l, body mass index <33 kg/m2, age <41 years. HGH or placebo were added from the start of the cycle in a double-blinded manner. The primary outcome was live birth rate.

      Main results

      The live birth rates following an IVF cycle were 9/62 (14.5%) for growth hormone and 7/51 (13.7%) for the placebo group (risk difference 0.8%, 95% confidence interval [CI] –12.1 to 13.7%; odds ratio [OR] 1.07, 95% CI 0.37–3.10). There was a greater odds of oocyte retrieval with growth hormone (OR 5.67, 95% CI 1.54–20.80) but no better chance of embryo transfer (OR 1.42, 95% CI 0.50–4.00). Birth weights were comparable.

      Conclusions

      Planned participant numbers were not reached. It was not possible to demonstrate an increase in live birth rate from the addition of growth hormone in women with a previous poor ovarian response to IVF.

      Keywords

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      Biography

      Robert Norman is a Professor of Reproduction and Periconceptual Medicine at the University of Adelaide. He is a subspecialist in reproductive medicine and is former President of Aspire – the Asia Pacific Initiative on Reproduction.
      Key message
      Human growth hormone has been advocated to improve pregnancy results following IVF in poor responders. A randomized controlled trial of the hormone versus placebo failed to support this hypothesis.