NCT06321107

Brief 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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
158

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Mar 2024

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2024

Completed
5 days until next milestone

First Submitted

Initial submission to the registry

March 6, 2024

Completed
14 days until next milestone

First Posted

Study publicly available on registry

March 20, 2024

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 15, 2025

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 31, 2025

Completed
Last Updated

April 8, 2025

Status Verified

March 1, 2025

Enrollment Period

1.5 years

First QC Date

March 6, 2024

Last Update Submit

April 6, 2025

Conditions

Infertility

Outcome Measures

Primary Outcomes (1)

  • Summary of Pregnancy Outcome

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

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

Secondary Outcomes (2)

  • neonatal birth outcomes

    To be assessed at birth (up to 10 months)

  • Infant development

    up to infant age 12 months

Study Arms (2)

Test group

Gensci094

Control group

rFSH

Eligibility Criteria

Age20 Years - 39 Years
Sexfemale(Gender-based eligibility)
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Subjects who indentified an ongoing pregnancy in Phase II or Phase III clinical trial of GenSci094

You may qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Guangzhou, Guangdong, China

Location

MeSH Terms

Conditions

Infertility

Condition Hierarchy (Ancestors)

Genital DiseasesUrogenital Diseases

Study Officials

  • Xiaoyan Liang, doctor

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

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
OTHER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 6, 2024

First Posted

March 20, 2024

Study Start

March 1, 2024

Primary Completion

August 15, 2025

Study Completion

October 31, 2025

Last Updated

April 8, 2025

Record last verified: 2025-03

Locations

CN(1)