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

Robert J. Norman; Helen Alvino; Louise M. Hull; Ben W. Mol; Roger J. Hart; Thu Lan Kelly; Luk Rombauts

doi:10.1016/j.rbmo.2019.02.003

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

Robert J. Norman^* (Corresponding Author), Helen Alvino, Louise M. Hull, Ben W. Mol, Roger J. Hart, Thu Lan Kelly, Luk Rombauts

^*Corresponding author for this work

Research output: Contribution to journal › Article › peer-review

45 Citations (Scopus)

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.

Original language	English
Pages (from-to)	908-915
Number of pages	8
Journal	Reproductive Biomedicine Online
Volume	38
Issue number	6
Early online date	22 May 2019
DOIs	https://doi.org/10.1016/j.rbmo.2019.02.003
Publication status	Published - Jun 2019

Bibliographical note

Declaration: RJN is a unitholder in a fertility company, Fertility SA, and has received travel and grant funding from Ferring and Merck; HA is a shareholder in a fertility company, Monash IVF; LH has nothing to declare; BWM reports consultancy for ObsEva, Merck and Guerbet, and research grants from Guerbet and Merck; RH is a shareholder in a fertility company, Fertility Specialists of Western Australia, has grant support from MSD, Merck Serono, Ferring Pharmaceuticals; TLK has nothing to declare; LR is a shareholder in Monash IVF Group and has received unrestricted educational and research sponsorship from MSD, Merck and Ferring Pharmaceuticals.

Acknowledgements
The LIGHT team thanks participants and clinics for recruitment. Merck Serono provided an unrestricted grant as well as study drug and placebo. They had no role in design, interpretation or writing of the manuscript.

Data Availability Statement

No data availability statement

Keywords

Human growth hormone
IVF
Live birth
Poor responders
Randomized controlled trial

UN SDGs

This output contributes to the following UN Sustainable Development Goals (SDGs)

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10.1016/j.rbmo.2019.02.003

Cite this

@article{f56a6e5ad1c14340913d52647336bf9c,

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

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 = "Human growth hormone, IVF, Live birth, Poor responders, Randomized controlled trial",

author = "Norman, {Robert J.} and Helen Alvino and Hull, {Louise M.} and Mol, {Ben W.} and Hart, {Roger J.} and Kelly, {Thu Lan} and Luk Rombauts",

note = "Declaration: RJN is a unitholder in a fertility company, Fertility SA, and has received travel and grant funding from Ferring and Merck; HA is a shareholder in a fertility company, Monash IVF; LH has nothing to declare; BWM reports consultancy for ObsEva, Merck and Guerbet, and research grants from Guerbet and Merck; RH is a shareholder in a fertility company, Fertility Specialists of Western Australia, has grant support from MSD, Merck Serono, Ferring Pharmaceuticals; TLK has nothing to declare; LR is a shareholder in Monash IVF Group and has received unrestricted educational and research sponsorship from MSD, Merck and Ferring Pharmaceuticals. Acknowledgements The LIGHT team thanks participants and clinics for recruitment. Merck Serono provided an unrestricted grant as well as study drug and placebo. They had no role in design, interpretation or writing of the manuscript.",

year = "2019",

month = jun,

doi = "10.1016/j.rbmo.2019.02.003",

language = "English",

volume = "38",

pages = "908--915",

journal = "Reproductive Biomedicine Online",

issn = "1472-6483",

publisher = "Elsevier",

number = "6",

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TY - JOUR

T1 - Human growth hormone for poor responders

T2 - a randomized placebo-controlled trial provides no evidence for improved live birth rate

AU - Norman, Robert J.

AU - Alvino, Helen

AU - Hull, Louise M.

AU - Mol, Ben W.

AU - Hart, Roger J.

AU - Kelly, Thu Lan

AU - Rombauts, Luk

N1 - Declaration: RJN is a unitholder in a fertility company, Fertility SA, and has received travel and grant funding from Ferring and Merck; HA is a shareholder in a fertility company, Monash IVF; LH has nothing to declare; BWM reports consultancy for ObsEva, Merck and Guerbet, and research grants from Guerbet and Merck; RH is a shareholder in a fertility company, Fertility Specialists of Western Australia, has grant support from MSD, Merck Serono, Ferring Pharmaceuticals; TLK has nothing to declare; LR is a shareholder in Monash IVF Group and has received unrestricted educational and research sponsorship from MSD, Merck and Ferring Pharmaceuticals. Acknowledgements The LIGHT team thanks participants and clinics for recruitment. Merck Serono provided an unrestricted grant as well as study drug and placebo. They had no role in design, interpretation or writing of the manuscript.

PY - 2019/6

Y1 - 2019/6

N2 - 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.

AB - 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.

KW - Human growth hormone

KW - IVF

KW - Live birth

KW - Poor responders

KW - Randomized controlled trial

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

Abstract

Bibliographical note

Data Availability Statement

Keywords

UN SDGs

Access to Document

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