Evidence map›Paper›PMID 39837901›Full record

Trial reportScientific reports2025

The first multiple center prospective study of rhFSH CTP in patients undergoing assisted reproductive technology in China.

Longmei Wu, Huayan Yin, Lingfang Guan, Guanjian Li, Junqiang Zhang, Qunshan Shen, Xiaoqing Ni, Chao Wang, Tianjuan Wang, Hao Geng and 4 more

Abstract readClinical Trial, Phase IIIEquivalence TrialMulticenter Study
In one paragraph

Trial report in Scientific reports, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

1 citing paper in PubMed.

  1. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

14 authors.

Longmei WuDepartment of Obstetrics and Gynecology, The First Affiliated Hospital of Anhui Medical University, Hefei, 230032, China.
Huayan YinDepartment of Obstetrics and Gynecology, The First Affiliated Hospital of Anhui Medical University, Hefei, 230032, China.
Lingfang GuanDepartment of Obstetrics and Gynecology, The First Affiliated Hospital of Anhui Medical University, Hefei, 230032, China.
Guanjian LiDepartment of Obstetrics and Gynecology, The First Affiliated Hospital of Anhui Medical University, Hefei, 230032, China.
Junqiang ZhangDepartment of Obstetrics and Gynecology, The First Affiliated Hospital of Anhui Medical University, Hefei, 230032, China.
Qunshan ShenDepartment of Obstetrics and Gynecology, The First Affiliated Hospital of Anhui Medical University, Hefei, 230032, China.
Xiaoqing NiDepartment of Obstetrics and Gynecology, The First Affiliated Hospital of Anhui Medical University, Hefei, 230032, China.
Chao WangDepartment of Obstetrics and Gynecology, The First Affiliated Hospital of Anhui Medical University, Hefei, 230032, China.
Tianjuan WangDepartment of Obstetrics and Gynecology, The First Affiliated Hospital of Anhui Medical University, Hefei, 230032, China.
Hao GengDepartment of Obstetrics and Gynecology, The First Affiliated Hospital of Anhui Medical University, Hefei, 230032, China.
Chuan XuDepartment of Obstetrics and Gynecology, The First Affiliated Hospital of Anhui Medical University, Hefei, 230032, China.
Yunxia CaoDepartment of Obstetrics and Gynecology, The First Affiliated Hospital of Anhui Medical University, Hefei, 230032, China. caoyunxia6@126.com.
Xiaojin HeDepartment of Obstetrics and Gynecology, The First Affiliated Hospital of Anhui Medical University, Hefei, 230032, China. hxj0117@126.com.
Bing SongDepartment of Obstetrics and Gynecology, The First Affiliated Hospital of Anhui Medical University, Hefei, 230032, China. songbing060907@126.com.

Funding

Anhui Provincial Health and Wellness Research Project AHWJ2023BAc20006Foundation of Education Department of Anhui Province for Outstanding Young Teachers gxgwfx2022009Project of Anhui Institute of Translational Medicine 2021zhyx-C36The Clinical Medical Research Transformation Project of Anhui Province 202204295107020009
6 · The paper itself

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.

Indexed as

Follicle Stimulating HormoneOvulation InductionReproductive Techniques, AssistedAdultChinaFemaleFertilization in VitroHumansPregnancyPregnancy OutcomePregnancy RateProspective StudiesFollicle Stimulating HormoneEmbryo transferIn vitro fertilizationOvarian stimulationrhFSH-CTP

Identifiers

PMID39837901
PMCPMC11751185

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC-ND
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Registered trials

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.