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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Total Enrollment

158 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-03-01

Study Completion Date

2025-10-31

Brief Summary

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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.

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Detailed Description

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Two previous RCTs (a phase II and phase III studies of GenSci094, one is NCT06091436) investigated if a single injection of GenSci094 was non-inferior to daily treatment with recFSH in initiating multi-follicular growth. The two studies followed 12 weeks after embryo transfer. This study is a follow-up to the above mentioned RCTs. The purpose of this study is to follow-up with participants of the original study to determine the long-term effect a single injection of GenSci094 during Controlled Ovarian Stimulation might have on newborns until they are 1 year old.

Conditions

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Infertility

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

OTHER

Study Groups

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Test group

Gensci094

No interventions assigned to this group

Control group

rFSH

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

1. Willing and able to sign informed consent
2. Subjects who participated in Phase II or Phase III clinical trial of GenSci094 and received at least one treatment with GenSci094 or Gonal-F ®
3. Subjects who indentified an ongoing pregnancy in Phase II or Phase III clinical trial of GenSci094