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

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT06321107

Enrollment

158

Registered

2024-03-20

Start date

2024-03-01

Completion date

2025-10-31

Last updated

2025-04-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Infertility

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.

Interventions

None listed

Study design

Observational model

CASE_CONTROL

Time perspective

OTHER

Eligibility

Sex/Gender

FEMALE

Age

20 Years to 39 Years

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

Exclusion criteria

Design outcomes

Primary

Measure	Time frame	Description
Summary of Pregnancy Outcome	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

Measure	Time frame	Description
neonatal birth outcomes	To be assessed at birth (up to 10 months)	To be assessed by the birth attendant/ Obgyne
Infant development	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.

Countries

China

Outcome results