Efficacy and safety of pulsatile gonadotropin-releasing hormone therapy in patients with congenital hypogonadotropic hypogonadism: a multicentre clinical study

Ming Hao; Jiang-Feng Mao; Qing-Bo Guan; Long Tian; Hu Han; Hong-En Lei; Dong-Mei Zheng; Zhen-Hua Tian; Min Nie; Xi Wang; Bing-Qing Yu; Yin-Jie Gao; Xue-Yan Wu

doi:10.21037/atm-21-1632

Efficacy and safety of pulsatile gonadotropin-releasing hormone therapy in patients with congenital hypogonadotropic hypogonadism: a multicentre clinical study

Ann Transl Med. 2021 Jun;9(12):962. doi: 10.21037/atm-21-1632.

Authors

Ming Hao^{1

2}, Jiang-Feng Mao¹, Qing-Bo Guan³, Long Tian⁴, Hu Han⁴, Hong-En Lei⁴, Dong-Mei Zheng³, Zhen-Hua Tian³, Min Nie¹, Xi Wang¹, Bing-Qing Yu¹, Yin-Jie Gao¹, Xue-Yan Wu¹

Affiliations

¹ NHC Key Laboratory of Endocrinology, Peking Union Medical College Hospital; Department of Endocrinology, Peking Union Medical College Hospital, Peking Union Medical College, Chinese Academy of Medical Sciences, Beijing, China.
² Department of Endocrinology, The First Affiliated Hospital of Harbin Medical University, Harbin, China.
³ Department of Endocrinology, Shandong Provincial Hospital Affiliated to Shandong University, Jinan, China.
⁴ Department of Urology, Beijing Chao Yang Hospital, Beijing, China.

Abstract

Background: Pulsatile gonadotropin-releasing hormone (GnRH) therapy may restore function of the hypothalamus-pituitary-gonad axis and induce spermatogenesis in male patients with congenital hypogonadotropic hypogonadism (CHH). The study sought to test the reliability of a newly developed Innopump^® hormone pump, and to confirm the efficacy and safety of pulsatile GnRH therapy (by Innopump^® hormone pump) in CHH patients.

Methods: From November 2017 to November 2018, 28 male patients with CHH were treated with pulsatile GnRH at Peking Union Medical College Hospital, Beijing Chaoyang Hospital, and Shandong Provincial Hospital. A prospective, self-controlled, 7-day clinical trial was conducted. The primary outcome measures were the efficacy and safety of pulsatile GnRH therapy (which was administered via the Innopump^® hormone pump). The secondary outcome measures included total serum testosterone, luteinizing hormone (LH) and follicle stimulating hormone (FSH) levels.

Results: All of the patients participated the clinical study. For 7 days, a dosage prescribed by doctors was accurately administered by the Innopump^® hormone pump, and recorded by the pump. During the treatment, LH and FSH levels gradually increased to 2.66±1.74 and 5.05±3.03 IU/L, respectively. Upper respiratory tract infection in 1 patient and slight nausea in another patient were reported, which were confirmed to be unrelated to the pulsatile GnRH therapy.

Conclusions: The Innopump^® hormone pump was found to be reliable in drug administration, and to have an accurate alarming system. It effectively and safely treated patients with CHH. Pulsatile GnRH therapy may produce a physiological pattern of GnRH secretion, and re-establish pituitary-gonad axis function by increasing gonadotropin levels.

Keywords: Innopump® hormone pump; Pulsatile gonadotropin-releasing hormone therapy (pulsatile GnRH therapy); congenital hypogonadotropic hypogonadism (CHH); spermatogenesis.