Application of recombinant Human Follitropin Alfa solution for injection in patients with symptoms/signs of polycystic ovary syndrome: a prospective, observational study
10.3760/cma.j.cn101441-20210727-00323
- VernacularTitle:重组人促卵泡激素预充注射笔应用于有多囊卵巢综合征症状/体征患者的前瞻性、观察性研究
- Author:
Guimin HAO
1
;
Yan SHENG
;
Xiaohong WANG
;
Xiaoguang SHAO
;
Xiufeng LING
;
Qiongfang WU
;
Xiaolin LA
;
Zhaolian WEI
;
Xiujuan CHEN
;
Wenhui FANG
Author Information
1. 河北医科大学第二医院生殖医学中心，石家庄 050000
- Publication Type:Journal Article
- Keywords:
Reproductive techniques, assisted;
Polycystic ovary syndrome;
Precision medicine;
Controlled ovarian stimulation;
Real-world evidence
- From:
Chinese Journal of Reproduction and Contraception
2022;42(11):1157-1166
- CountryChina
- Language:Chinese
-
Abstract:
Objective:To evaluate the association between polycystic ovary syndrome (PCOS)-related symptom combinations and ovarian stimulation high response in infertile patients with PCOS symptoms and controlled ovarian stimulation treatment by recombinant Human Follitropin Alfa (r-hFSHα) solution for injection, and to evaluate the efficacy and safety outcomes of using the r-hFSHα prefilled injection pen in high-risk patients with ovarian hyperstimulation syndrome (OHSS).Methods:This prospective, observational, phase Ⅳ study enrolled 1055 patients with at least one symptom/sign of PCOS using the r-hFSHα prefilled pen for over 4 months follow-up observation from December 2015 to September 2017 in the Second Hospital of Hebei Medical University, Center for Reproductive Medicine, Shandong University, Tangdu Hospital of the Air Force Military Medical University, Dalian Maternity and Child Health Care Hospital, Nanjing Maternity and Child Health Care Hospital, Jiangxi Maternity and Child Health Care Hospital, the First Affiliated Hospital of Xinjiang Medical University, the First Affiliated Hospital of Anhui Medical University, the Affiliated Hospital of Inner Mongolia Medical University. The primary endpoints assessed included the development of polycystic ovaries, elevated serum testosterone levels, menstrual cycle disturbances, development of hirsutism, and completion of egg retrieval. The efficacy endpoints of the study included the number of ocoytes retrieved, the number of M Ⅱ oocyte, the biochemical pregnancy rate, the clinical pregnancy rate, and the implantation rate. Results:In the full analysis set ( n=997), polycystic ovary rate was 54.5% (543/997), serum testosterone level was (0.4±0.2) μg/L, menstrual cycle disorder rate was 45.0% (449/997), hirsutism rate was 10.5% (105/997). The average number of oocytes retrieved after ovarian stimulation was 14.4. The clinical pregnancy rate per transfer cycle was 53.6% (251/468), the live birth rate was 45.3% (212/468), the biochemical pregnancy rate was 60.9% (285/468), the implantation rate was 39.1% (349/893), and the fresh embryo transfer cancellation rate was 24.0% (239/997). OHSS incidence was diagnosed in 1.8% (19/1054) of patients (safety set, n=1054), including 8 (0.8%) mild cases, 10 (0.9%) moderate cases and 1 (0.1%) severe case. According to the results of exploratory analysis, a decrease in body mass index (BMI) was associated with an increased risk of high response. For every 1 kg/m 2 decrease in BMI, the risk of high response (number of retrieved oocytes >15) increased by approximately 9%, the risk of high response (number of retrieved oocytes >20) increased by approximately 9%. For every 1 increase in antral follicle count (AFC), the risk of high response(number of retrieved oocytes >15) increased by approximately 6% and the risk of high response (number of retrieved oocytes >20) by approximately 4%. Conclusion:Patients with at least one symptom/sign of ovarian hyperstimulation achieved good clinical outcomes with the use of the r-hFSHα prefilled pen, and high response was associated with lower BMI and AFC.
