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Long-term Follow-up Safety of a Single Injection of GenSci094 for Ovarian Stimulation Using Daily Recombinant FSH as Reference - Trial NCT06321107

Access comprehensive clinical trial information for NCT06321107 through Pure Global AI's free database. This phase not specified trial is sponsored by Changchun GeneScience Pharmaceutical Co., Ltd. and is currently Recruiting. The study focuses on Infertility. Target enrollment is 158 participants.

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NCT06321107
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Trial Details
ClinicalTrials.gov • NCT06321107
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Long-term Follow-up Safety of a Single Injection of GenSci094 for Ovarian Stimulation Using Daily Recombinant FSH as Reference
A Phase II/III Extension Study Comparing the Long-term Safety of GenSci094 and Gonal-f® in Chinese ART Patients

Study Focus

Infertility

Observational

Sponsor & Location

Changchun GeneScience Pharmaceutical Co., Ltd.

Guangzhou, China

Timeline & Enrollment

N/A

Feb 29, 2024

Oct 31, 2025

158 participants

Primary Outcome

Summary of Pregnancy Outcome

Summary

The purpose of this study is to evaluate the safety of a single injection of GenSci094 during
 Controlled Ovarian Stimulation up to 1 year old of the infants from previous studies.

ICD-10 Classifications

Female infertility
Male infertility
Female infertility, unspecified
Female infertility of other origin
Female infertility of uterine origin

Data Source

ClinicalTrials.gov

NCT06321107

Non-Device Trial