Robert J Norman1, Helen Alvino2, Louise M Hull2, Ben W Mol3, Roger J Hart4, Thu-Lan Kelly5, Luk Rombauts6. 1. University of Adelaide, Robinson Research Institute, North Adelaide, SA 5006, Australia; , Fertility SA, 431 King William Road, Adelaide, SA 5000, Australia. Electronic address: robert.norman@adelaide.edu.au. 2. University of Adelaide, Robinson Research Institute, North Adelaide, SA 5006, Australia. 3. 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. 4. Fertility Specialists of Western Australia, Claremont, WA 6010; The University of Western Australia, Crawley, WA 6009, Australia. 5. 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. 6. Monash IVF, Monash Surgical Private Hospital, Clayton, VIC 3168, Australia.
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.
RCT Entities:
RESEARCH QUESTION: Does the addition of humangrowth 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.
Authors: Thor Haahr; Carlos Dosouto; Carlo Alviggi; Sandro C Esteves; Peter Humaidan Journal: Front Endocrinol (Lausanne) Date: 2019-09-11 Impact factor: 5.555