Long-term Follow-up Safety of a Single Injection of GenSc... | NCT06321107

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

NCT06321107

Sponsor

Changchun GeneScience Pharmaceutical Co., Ltd.

Status

Active, not recruiting

Last Update Posted

Apr 8, 2025Actual

Enrollment

158Estimated

Phase

Not provided

Conditions

Infertility

Interventions

Not provided

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2025

Overall Recruitment Status or Expanded Access Status

Active, not recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 1, 2024Actual

Primary Completion Date

Aug 15, 2025Estimated

Completion Date

Oct 31, 2025Estimated

First Submitted Date

Mar 6, 2024

First Submission Date that Met QC Criteria

Mar 17, 2024

First Posted Date

Mar 20, 2024Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 6, 2025

Last Update Posted Date

Apr 8, 2025Actual

Name	Class
Sixth Affiliated Hospital, Sun Yat-sen University	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

158Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Test group		Gensci094
Control group		rFSH

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Measure	Description	Time Frame
neonatal birth outcomes	To be assessed by the birth attendant/ Obgyne	To be assessed at birth (up to 10 months)
Infant development	To assess infant's development, weight in grams/kilograms, height in centimeters and head circumference in centimeters are measured.

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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:

Accepts Healthy Volunteers

Not provided

Sex

Female

Sex/Gender Based

Yes

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

39 Years

Standard Ages

Adult

Study Population

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

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Xiaoyan Liang, doctor	The Sixth Affiliated Hospital, Sun Yat-sen University Guangdong Gastrointestinal Hospital	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
The Sixth Affiliated Hospital, Sun Yat-sen University Guangdong Gastrointestinal Hospital		Guangzhou	Guangdong		China

Condition Browse Module

MeSH Terms

ID	Term
D007246	Infertility

Ancestor Terms

ID	Term
D000091662	Genital Diseases
D000091642	Urogenital Diseases

Browse Leaves

Not provided

Browse Branches

Not provided