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NCT Number: NCT06321107

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

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Conditions

Infertility Genital Diseases Urogenital Diseases

Age range

20 year–39 year

Sex eligibility

Female

Study type

Observational

Primary location

The Sixth Affiliated Hospital, Sun Yat-sen University Guangdong Gastrointestinal Hospital

Guangzhou, Guangdong, China

About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

NA

Treatment and study plan

Primary outcomes

  1. Summary of Pregnancy Outcome

    Time frame: To be assessed at late abortion or birth (up to 10 months)

    Pregnancy outcomes were reported at the optional long-term follow up visit.

Secondary outcomes

  1. neonatal birth outcomes

    Time frame: To be assessed at birth (up to 10 months)

    To be assessed by the birth attendant/ Obgyne

  2. Infant development

    Time frame: up to infant age 12 months

    To assess infant's development, weight in grams/kilograms, height in centimeters and head circumference in centimeters are measured.

Sponsors and collaborators

Lead sponsor

Changchun GeneScience Pharmaceutical Co., Ltd.

Industry

Collaborators

  • Sixth Affiliated Hospital, Sun Yat-sen University

Registry information

Official study title

A Phase II/III Extension Study Comparing the Long-term Safety of GenSci094 and Gonal-f® in Chinese ART Patients

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Mar 20, 2024
Registry last updated
Apr 8, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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