The first multiple center prospective study of rhFSH CTP in patients undergoing assisted reproductive technology in China
Abstract We assessed the safety and efficacy of rhFSH-CTP, a novel long-acting FSH agent, in controlled ovarian hyperstimulation for patients undergoing ART. A multi-center, open-label, randomized, positive-control, non-inferiority clinical trial was conducted. The study consisted of a phase III ran...
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Nature Portfolio
2025-01-01
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| Online Access: | https://doi.org/10.1038/s41598-025-86962-4 |
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| author | Longmei Wu Huayan Yin Lingfang Guan Guanjian Li Junqiang Zhang Qunshan Shen Xiaoqing Ni Chao Wang Tianjuan Wang Hao Geng Chuan Xu Yunxia Cao Xiaojin He Bing Song |
| author_facet | Longmei Wu Huayan Yin Lingfang Guan Guanjian Li Junqiang Zhang Qunshan Shen Xiaoqing Ni Chao Wang Tianjuan Wang Hao Geng Chuan Xu Yunxia Cao Xiaojin He Bing Song |
| author_sort | Longmei Wu |
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| description | Abstract We assessed the safety and efficacy of rhFSH-CTP, a novel long-acting FSH agent, in controlled ovarian hyperstimulation for patients undergoing ART. A multi-center, open-label, randomized, positive-control, non-inferiority clinical trial was conducted. The study consisted of a phase III randomized design, with a 1:1 ratio favoring the rhFSH-CTP group over the control group. Eligible patients in the rhFSH-CTP group received a single dose of rhFSH-CTP at 100–150 µg for the first 7d of stimulation following a gonadotropin-releasing hormone antagonist protocol. In total, 142 and 141 patients received rhFSH-CTP and rhFSH, respectively. At a confidence interval of 95%, the difference in the number of oocytes (1.13–4.22, 2.67) suggested that rhFSH-CTP was not inferior to rhFSH. Additionally, the top-quality embryos, implantation rates, and pregnancy outcomes were similar between the two groups (P > 0.05). In the rhFSH-CTP group, no cases of severe OHSS were observed, which was a significant improvement compared to the 1.4% incidence in the rhFSH group. With regard to another safety endpoint, no patients tested positive for adenosine deaminase (ADA) in the rhFSH-CTP group. The results demonstrated that the product had a comparable safety profile to pregnancy outcomes and newborn information in the control group, indicating its suitability for use. |
| format | Article |
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| institution | Kabale University |
| issn | 2045-2322 |
| language | English |
| publishDate | 2025-01-01 |
| publisher | Nature Portfolio |
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| series | Scientific Reports |
| spelling | doaj-art-a9425580fb7d43fd8d3b2203b73a14e02025-01-26T12:30:03ZengNature PortfolioScientific Reports2045-23222025-01-0115111210.1038/s41598-025-86962-4The first multiple center prospective study of rhFSH CTP in patients undergoing assisted reproductive technology in ChinaLongmei Wu0Huayan Yin1Lingfang Guan2Guanjian Li3Junqiang Zhang4Qunshan Shen5Xiaoqing Ni6Chao Wang7Tianjuan Wang8Hao Geng9Chuan Xu10Yunxia Cao11Xiaojin He12Bing Song13Department of Obstetrics and Gynecology, The First Affiliated Hospital of Anhui Medical UniversityDepartment of Obstetrics and Gynecology, The First Affiliated Hospital of Anhui Medical UniversityDepartment of Obstetrics and Gynecology, The First Affiliated Hospital of Anhui Medical UniversityDepartment of Obstetrics and Gynecology, The First Affiliated Hospital of Anhui Medical UniversityDepartment of Obstetrics and Gynecology, The First Affiliated Hospital of Anhui Medical UniversityDepartment of Obstetrics and Gynecology, The First Affiliated Hospital of Anhui Medical UniversityDepartment of Obstetrics and Gynecology, The First Affiliated Hospital of Anhui Medical UniversityDepartment of Obstetrics and Gynecology, The First Affiliated Hospital of Anhui Medical UniversityDepartment of Obstetrics and Gynecology, The First Affiliated Hospital of Anhui Medical UniversityDepartment of Obstetrics and Gynecology, The First Affiliated Hospital of Anhui Medical UniversityDepartment of Obstetrics and Gynecology, The First Affiliated Hospital of Anhui Medical UniversityDepartment of Obstetrics and Gynecology, The First Affiliated Hospital of Anhui Medical UniversityDepartment of Obstetrics and Gynecology, The First Affiliated Hospital of Anhui Medical UniversityDepartment of Obstetrics and Gynecology, The First Affiliated Hospital of Anhui Medical UniversityAbstract We assessed the safety and efficacy of rhFSH-CTP, a novel long-acting FSH agent, in controlled ovarian hyperstimulation for patients undergoing ART. A multi-center, open-label, randomized, positive-control, non-inferiority clinical trial was conducted. The study consisted of a phase III randomized design, with a 1:1 ratio favoring the rhFSH-CTP group over the control group. Eligible patients in the rhFSH-CTP group received a single dose of rhFSH-CTP at 100–150 µg for the first 7d of stimulation following a gonadotropin-releasing hormone antagonist protocol. In total, 142 and 141 patients received rhFSH-CTP and rhFSH, respectively. At a confidence interval of 95%, the difference in the number of oocytes (1.13–4.22, 2.67) suggested that rhFSH-CTP was not inferior to rhFSH. Additionally, the top-quality embryos, implantation rates, and pregnancy outcomes were similar between the two groups (P > 0.05). In the rhFSH-CTP group, no cases of severe OHSS were observed, which was a significant improvement compared to the 1.4% incidence in the rhFSH group. With regard to another safety endpoint, no patients tested positive for adenosine deaminase (ADA) in the rhFSH-CTP group. The results demonstrated that the product had a comparable safety profile to pregnancy outcomes and newborn information in the control group, indicating its suitability for use.https://doi.org/10.1038/s41598-025-86962-4rhFSH-CTPOvarian stimulationIn vitro fertilizationEmbryo transfer |
| spellingShingle | Longmei Wu Huayan Yin Lingfang Guan Guanjian Li Junqiang Zhang Qunshan Shen Xiaoqing Ni Chao Wang Tianjuan Wang Hao Geng Chuan Xu Yunxia Cao Xiaojin He Bing Song The first multiple center prospective study of rhFSH CTP in patients undergoing assisted reproductive technology in China Scientific Reports rhFSH-CTP Ovarian stimulation In vitro fertilization Embryo transfer |
| title | The first multiple center prospective study of rhFSH CTP in patients undergoing assisted reproductive technology in China |
| title_full | The first multiple center prospective study of rhFSH CTP in patients undergoing assisted reproductive technology in China |
| title_fullStr | The first multiple center prospective study of rhFSH CTP in patients undergoing assisted reproductive technology in China |
| title_full_unstemmed | The first multiple center prospective study of rhFSH CTP in patients undergoing assisted reproductive technology in China |
| title_short | The first multiple center prospective study of rhFSH CTP in patients undergoing assisted reproductive technology in China |
| title_sort | first multiple center prospective study of rhfsh ctp in patients undergoing assisted reproductive technology in china |
| topic | rhFSH-CTP Ovarian stimulation In vitro fertilization Embryo transfer |
| url | https://doi.org/10.1038/s41598-025-86962-4 |
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