InfertilityNCT06321107
Long-term Follow-up Safety of a Single Injection of GenSci094 for Ovarian Stimulation Using Daily Recombinant FSH as Reference
An observational study of Infertility, run by Changchun GeneScience Pharmaceutical Co., Ltd. at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 39 years, women only
- Conditions the study is for
- Infertility
- How many people
- 158 participants
- Where
- 1 siteChina
- Study dates
- 1 Mar 2024to 31 Oct 2025
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 39 years
- Women only
- Adult
Study population: Subjects who indentified an ongoing pregnancy in Phase II or Phase III clinical trial of GenSci094
Who may be able to join
- 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
Who cannot join
- NA
Trial locations and contacts
1 site in 1 country.
China1 site
The Sixth Affiliated Hospital, Sun Yat-sen University Guangdong Gastrointestinal Hospital
Guangzhou, Guangdong
About this study
Official title: A Phase II/III Extension Study Comparing the Long-term Safety of GenSci094 and Gonal-f® in Chinese ART Patients
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.
Read the 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.
- Conditions
- Infertility
- Medical subject headings
- Infertility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Test group | Gensci094 | |
| Control group | rFSH |
What is being measured
The primary outcome is the main question the study is designed to answer.
Summary of Pregnancy Outcome
Pregnancy outcomes were reported at the optional long-term follow up visit.
Measured: To be assessed at late abortion or birth (up to 10 months)
Secondary outcomes (2)
neonatal birth outcomes
To be assessed by the birth attendant/ Obgyne
Measured: 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.
Measured: up to infant age 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2024
- Study start1 Mar 2024
- Primary completion15 Aug 2025 (estimated)
- Study completion31 Oct 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for InfertilityStudies of the same condition, open and under way.
- More trials run by Changchun GeneScience Pharmaceutical Co., Ltd.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Other
- Enrolment
- 158 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Changchun GeneScience Pharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Sixth Affiliated Hospital, Sun Yat-sen University
- Responsible party
- Sponsor
- Investigators
- Xiaoyan Liang, doctor, Study chair, The Sixth Affiliated Hospital, Sun Yat-sen University Guangdong Gastrointestinal Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06321107
- Sponsor's protocol ID
- GenSci094-304
- Status last verified
- Mar 2025
- First submitted
- 6 Mar 2024
- Last updated
- 8 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II/III Extension Study Comparing the Long-term Safety of GenSci094 and Gonal-f® in Chinese ART Patients
- ClinicalTrials.gov ID
- NCT06321107
- Acronym / sponsor ID
- GenSci094-304
- Conditions
- Infertility
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 158 participants (estimated)
- Lead sponsor
- Changchun GeneScience Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Collaborators
- Sixth Affiliated Hospital, Sun Yat-sen University
- Study start
- 1 Mar 2024 (actual)
- Primary completion
- 15 Aug 2025 (estimated)
- Study completion
- 31 Oct 2025 (estimated)
- First posted
- 20 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Other
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Test group | – | –Gensci094 |
| Control group | – | –rFSH |
Who may qualify
- Ages
- 20 to 39 years
- Sex
- Female only
- Age groups
- Adult
- Study population
- Subjects who indentified an ongoing pregnancy in Phase II or Phase III clinical trial of GenSci094
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (1 listed)
- NA
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
2 secondary outcomes
neonatal birth outcomes
Time frame: To be assessed at birth (up to 10 months)
Infant development
Time frame: up to infant age 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Apr 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Xiaoyan Liang, doctor study chair
The Sixth Affiliated Hospital, Sun Yat-sen University Guangdong Gastrointestinal Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Infertility, run by Changchun GeneScience Pharmaceutical Co., Ltd. at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 8 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Summary of Pregnancy Outcome (time frame: To be assessed at late abortion or birth (up to 10 months)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Apr 2025.