Which is the best IVF/ICSI protocol to be used in poor responders receiving growth hormone as an adjuvant treatment? A prospective randomized trial

Abstract

This open label randomized study aims to define the best protocol to be used with growth hormone in poor responders, with comparison performed to delineate which protocol offers the best cycle outcomes. Two-hundred eighty-seven poor responders were included. The patients were randomly allocated into four groups receiving growth hormone (GH) as an adjuvant therapy added to either long or short agonist protocol, miniflare or antagonist protocols. The short/GH gave significantly lower mean number of oocytes when compared with the long/GH, antagonist/GH and miniflare/GH (4 ± 1.69 versus 5.06 ± 1.83, 4.95 + / = 1.90 and4.98 ± 2.51, respectively p = 0.005). Considering the number of fertilized oocytes, the long/GH showed significantly higher levels than short/GH and antagonist/GH (3.73 ± 1.47 versus 3.02 ± 1.52 and 2.89 ± 1.14, respectively). The main drawback is that it required significantly higher HMG dose and longer duration of stimulation. The long/GH was superior when compared with the three protocols regarding the number of oocytes retrieved and fertilized. But, when considering the clinical pregnancy rates, there was a difference in favor of the long/GH but not reaching a statistically significant value (ClinicalTrials.gov Identifier: NCT01897324).

Chinese abstract

这一开放性随机对照研究的目的是确定生长激素辅助治疗低反应患者的最佳方案，通过进行对比确定哪个方案有最佳的周期结果。研究包括287个低反应患者。患者被随机分配到四组，接受生长激素(GH)作为辅助治疗联合长或短的激动剂方案, miniflare或拮抗剂方案。短方案/GH组获得的卵母细胞平均数明显低于长方案/GH组、 拮抗剂/GH组和miniflare/GH组（4±1.69 vs 5.06±1.83、4.95+/=1.90 及4.98±2.51，分别P=0.005）。关于受精的卵母细胞数目，长方案/GH组的受精卵母细胞数目明显高于短方案/GH组和拮抗剂/GH组（分别为3.73 ± 1.47 vs 3.02 ± 1.52 和2.89 ± 1.14）。主要缺点是它需要更高剂量的尿促性素及更长的刺激时间。关于获得的卵母细胞数和受精卵母细胞数，长方案/GH组优于其他的三个方案。但是,考虑到临床妊娠率,长方案/ GH组并没有达到统计上的显著意义(临床试验。政府编号：NCT01897324)。

• Antagonist protocol
• growth hormone
• IVF/ICSI
• long agonist protocol
• miniflare protocol
• poor responders
• short agonist protocol

Acknowledgements

We thank all the participants and staff of Cairo University, IVF center and Nile infertility center for their collaboration towards accomplishing this study.

Declaration of interest

The authors report no declarations of interest. There was no source of funding for this study.