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
UR - http://www.scopus.com/inward/record.url?scp=85063724092&partnerID=8YFLogxK
U2 - 10.1016/j.rbmo.2019.02.003
DO - 10.1016/j.rbmo.2019.02.003
M3 - Article
C2 - 30954433
AN - SCOPUS:85063724092
VL - 38
SP - 908
EP - 915
JO - Reproductive Biomedicine Online
JF - Reproductive Biomedicine Online
SN - 1472-6483
IS - 6
ER -
