InfertilityNCT07553728
Safety and Efficacy of Corifollitropin Alfa N02 Injection in Elderly Women Undergoing Assisted Reproductive Technology (ART)
An observational study of Infertility, run by Changchun GeneScience Pharmaceutical Co., Ltd. at 1 site in China.
Trial summary
This is a multi-centre, single-arm, observational trial to assess the safety and efficacy of corifollitropin alfa N02 Injection in elderly Chinese women undergoing ART, and then to explore the compliance and satisfaction during COS treatment. Read more about this study
- Who is it for?
- Ages 36 to 39 years, women only
- Conditions the study is for
- Infertility
- What is being tested?
- NA，Observational study
- Type of treatment
- Injection or infusion
- How many people
- 200 participants
- Where
- 1 siteChina
- Study dates
- 30 Apr 2026to 16 Dec 2029
- 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 36 to 39 years
- Women only
- No healthy volunteers
- Adult
Study population: Married women aged 36-39 years scheduled for controlled ovarian stimulation (COS) and IVF/ICSI assisted reproduction using a fixed antagonist protocol with Corifollitropin alfa N02 Injection.
Who may be able to join
- Able to communicate well with investigators, understand and comply with trial requirements, participate voluntarily, and provide signed informed consent after full understanding.
- Married women aged 36 to 40 years (exclusive of boundary values).
- Normal ovarian function: AMH ≥ 1.1 μg/L and basal FSH < 10 IU/L.
- Scheduled to undergo controlled ovarian stimulation (COS) and IVF/ICSI using a fixed antagonist protocol combined with Corifollitropin alpha N02 injection.
Who cannot join
- ≥3 previous cycles of controlled ovarian stimulation (COS)
- Recurrent pregnancy loss: ≥3 previous pregnancy losses (including spontaneous abortion, biochemical pregnancy, and missed abortion).
- Repeated implantation failure: ≥3 embryo transfer cycles (fresh or frozen) or failure to achieve clinical pregnancy after transfer of ≥4 high-quality embryos in total.
- High risk of ovarian hyperstimulation syndrome (OHSS), defined by any of the following:
- Diagnosed with polycystic ovary syndrome (PCOS);
- Total number of AFC in both ovaries >20 on Day 2-3 of menstruation; ③ Previous cycle cancellation (including canceled embryo transfer) due to high ovarian response or high OHSS risk; ④ History of OHSS; ⑤ Other conditions judged by the investigator to confer high OHSS risk after comprehensive evaluation.
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- Poor ovarian function, defined by any of the following:
- ① Previous poor ovarian response (≤3 oocytes retrieved following conventional full-dose gonadotropin stimulation);
- ② Total AFC in both ovaries <5.
- Presence of any reproductive, endocrine, or immune disorders that may affect pregnancy, as assessed by the investigator.
- Abnormal uterine bleeding.
- Presence of systemic diseases (e.g., cardiovascular, digestive, neurological, hematological disorders) deemed unsuitable for study participation by the investigator, or severe diseases incompatible with pregnancy.
- Hypersensitivity or history of allergy to active ingredients or excipients of gonadotropins (Gn), GnRH antagonists, or progesterone preparations, or with documented contraindications to these medications.
- History of alcoholism, heavy smoking, drug addiction, or substance abuse.
- Scheduled to undergo preimplantation genetic testing (PGT).
- Currently participating in another clinical trials and receiving investigational products.
- Any other conditions deemed by the investigator to render the subject unsuitable for trial participation based on safety considerations.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Peking University Third Hospital
Beijing, Beijing Municipality, 100191
Rong Li, Doctor, +86 13701085402, roseli001@sina.com
About this study
Official title: A Multi-center, Single-arm, Observational Study to Assess the Safety and Efficacy of Corifollitropin Alfa N02 Injection in Elderly Women Undergoing Assisted Reproductive Technology (ART)
This is a multi-centre, single-arm, observational trial to assess the safety and efficacy of corifollitropin alfa N02 Injection in elderly Chinese women undergoing ART, and then to explore the compliance and satisfaction during COS treatment.
- Conditions
- Infertility
- Being tested
- NA，Observational study
- Keywords
- assisted reproductive technology (ART), controlled ovarian stimulation (COS)
- Medical subject headings
- Infertility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NA，Observational studyOther
Data will be collected without interfering with routine clinical care.
| Study group | Role | What they receive |
|---|---|---|
| Corifollitropin alfa N02 Injection | Observe and record the safety and efficacy data of women receiving controlled ovarian stimulation therapy using Corifollitropin alfa N02 Injection Receives: Other: NA，Observational study |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of treatment-emergent adverse events (TEAEs)
Measured: From signing the ICF to the birth of the newborn
Secondary outcomes (23)
Incidence of early-onset ovarian hyperstimulation syndrome (OHSS)
Measured: Up to 9 days after triggering of final follicular maturation
Incidence of moderate to severe OHSS
Measured: Up to 10-11 weeks after transfer
fetal/newborn birth defects
Measured: Up to 15 months
1-year cumulative clinical pregnancy rate per initiated stimulation cycles
Measured: 4 to 6 weeks after last frozen embryo transfer
1-year cumulative ongoing pregnancy rate per initiated stimulation cycles
Measured: 9 to 11 weeks after last frozen embryo transfer
1-year cumulative live birth rate per initiated stimulation cycles
Measured: more than 40 weeks after last frozen embryo transfer
β-hCG/hCG positive rate per initiated stimulation cycles with fresh embryo transfer
Measured: 4 weeks after fresh embryo transfer
Clinical pregnancy rate per initiated stimulation cycles with fresh embryo transfer
Measured: 4 to 6 weeks after fresh embryo transfer
Ongoing pregnancy rate per initiated stimulation cycles with fresh embryo transfer
Measured: 9 to 11 weeks after fresh embryo transfer
Live birth rate per initiated stimulation cycles with fresh embryo transfer
Measured: more than 40 weeks after fresh embryo transfer
β-hCG/hCG positive rate per initiated stimulation cycles with first embryo transfer cycle
Measured: 4 weeks after first embryo transfer
Clinical pregnancy rate per initiated stimulation cycles with first embryo transfer cycle
Measured: 4 to 6 weeks after first embryo transfer
Ongoing pregnancy rate per initiated stimulation cycles with first embryo transfer cycle
Measured: 9 to 11 weeks after first embryo transfer
Live birth rate per initiated stimulation cycles with first embryo transfer cycle
Measured: more than 40 weeks after first embryo transfer
Pregnancy loss rate
Measured: Up to 38 weeks after transfer
Number of oocytes retrieved
Measured: Up to 22 days
Estrogen (E₂) and progesterone (P) levels during controlled ovarian stimulation (COS)
Measured: Up to 22 days
Follicular development status
Measured: Up to 22 days
Metaphase II (MII) oocyte rate [evaluated only in intracytoplasmic sperm injection (ICSI) cycles]
Measured: Up to 22 days
Fertilization rate Implantation rate
Measured: Day 3 after oocyte retrieval
Implantation rate
Measured: Up to 28 days
High-quality embryo rate
Measured: Day 3 after oocyte retrieval
Usable blastocyst formation rate
Measured: Day 5 after oocyte retrieval
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Apr 2026
- Study start30 Apr 2026
- Primary completion4 Aug 2029 (estimated)
- Study completion16 Dec 2029 (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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Changchun GeneScience Pharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07553728
- Sponsor's protocol ID
- GenSci094-401
- Status last verified
- Mar 2026
- First submitted
- 13 Apr 2026
- Last updated
- 28 Oct 2026
- 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 28 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-center, Single-arm, Observational Study to Assess the Safety and Efficacy of Corifollitropin Alfa N02 Injection in Elderly Women Undergoing Assisted Reproductive Technology (ART)
- ClinicalTrials.gov ID
- NCT07553728
- Acronym / sponsor ID
- GenSci094-401
- Conditions
- Infertility
- Keywords
- assisted reproductive technology (ART), controlled ovarian stimulation (COS)
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Changchun GeneScience Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 30 Apr 2026 (actual)
- Primary completion
- 4 Aug 2029 (estimated)
- Study completion
- 16 Dec 2029 (estimated)
- First posted
- 28 Apr 2026 (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.
This is a multi-centre, single-arm, observational trial to assess the safety and efficacy of corifollitropin alfa N02 Injection in elderly Chinese women undergoing ART, and then to explore the compliance and satisfaction during COS treatment.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Corifollitropin alfa N02 Injection | – | Other: NA，Observational studyObserve and record the safety and efficacy data of women receiving controlled ovarian stimulation therapy using Corifollitropin alfa N02 Injection |
Who may qualify
- Ages
- 36 to 39 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Married women aged 36-39 years scheduled for controlled ovarian stimulation (COS) and IVF/ICSI assisted reproduction using a fixed antagonist protocol with Corifollitropin alfa N02 Injection.
Key inclusion criteria (4 listed)
- Able to communicate well with investigators, understand and comply with trial requirements, participate voluntarily, and provide signed informed consent after full understanding.
- Married women aged 36 to 40 years (exclusive of boundary values).
- Normal ovarian function: AMH ≥ 1.1 μg/L and basal FSH < 10 IU/L.
- Scheduled to undergo controlled ovarian stimulation (COS) and IVF/ICSI using a fixed antagonist protocol combined with Corifollitropin alpha N02 injection.
Key exclusion criteria (17 listed)
- ≥3 previous cycles of controlled ovarian stimulation (COS)
- Recurrent pregnancy loss: ≥3 previous pregnancy losses (including spontaneous abortion, biochemical pregnancy, and missed abortion).
- Repeated implantation failure: ≥3 embryo transfer cycles (fresh or frozen) or failure to achieve clinical pregnancy after transfer of ≥4 high-quality embryos in total.
- High risk of ovarian hyperstimulation syndrome (OHSS), defined by any of the following:
- Poor ovarian function, defined by any of the following:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NA，Observational studyData will be collected without interfering with routine clinical care. | Other | Corifollitropin alfa N02 Injection |
Primary outcome
Incidence of treatment-emergent adverse events (TEAEs)
Time frame: From signing the ICF to the birth of the newborn
23 secondary outcomes
Incidence of early-onset ovarian hyperstimulation syndrome (OHSS)
Time frame: Up to 9 days after triggering of final follicular maturation
Incidence of moderate to severe OHSS
Time frame: Up to 10-11 weeks after transfer
fetal/newborn birth defects
Time frame: Up to 15 months
1-year cumulative clinical pregnancy rate per initiated stimulation cycles
Time frame: 4 to 6 weeks after last frozen embryo transfer
1-year cumulative ongoing pregnancy rate per initiated stimulation cycles
Time frame: 9 to 11 weeks after last frozen embryo transfer
1-year cumulative live birth rate per initiated stimulation cycles
Time frame: more than 40 weeks after last frozen embryo transfer
β-hCG/hCG positive rate per initiated stimulation cycles with fresh embryo transfer
Time frame: 4 weeks after fresh embryo transfer
Clinical pregnancy rate per initiated stimulation cycles with fresh embryo transfer
Time frame: 4 to 6 weeks after fresh embryo transfer
Ongoing pregnancy rate per initiated stimulation cycles with fresh embryo transfer
Time frame: 9 to 11 weeks after fresh embryo transfer
Live birth rate per initiated stimulation cycles with fresh embryo transfer
Time frame: more than 40 weeks after fresh embryo transfer
β-hCG/hCG positive rate per initiated stimulation cycles with first embryo transfer cycle
Time frame: 4 weeks after first embryo transfer
Clinical pregnancy rate per initiated stimulation cycles with first embryo transfer cycle
Time frame: 4 to 6 weeks after first embryo transfer
Ongoing pregnancy rate per initiated stimulation cycles with first embryo transfer cycle
Time frame: 9 to 11 weeks after first embryo transfer
Live birth rate per initiated stimulation cycles with first embryo transfer cycle
Time frame: more than 40 weeks after first embryo transfer
Pregnancy loss rate
Time frame: Up to 38 weeks after transfer
Number of oocytes retrieved
Time frame: Up to 22 days
Estrogen (E₂) and progesterone (P) levels during controlled ovarian stimulation (COS)
Time frame: Up to 22 days
Follicular development status
Time frame: Up to 22 days
Metaphase II (MII) oocyte rate [evaluated only in intracytoplasmic sperm injection (ICSI) cycles]
Time frame: Up to 22 days
Fertilization rate Implantation rate
Time frame: Day 3 after oocyte retrieval
Implantation rate
Time frame: Up to 28 days
High-quality embryo rate
Time frame: Day 3 after oocyte retrieval
Usable blastocyst formation rate
Time frame: Day 5 after oocyte retrieval
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 28 Oct 2026.
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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.
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 4 inclusion and 17 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: looking for participants now, as of the sponsor's last update on 28 Oct 2026. 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?
Contact Mengsheng Zhang (+86 18190952182, zhangmengsheng@genscigroup.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of treatment-emergent adverse events (TEAEs) (time frame: From signing the ICF to the birth of the newborn). 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 28 Oct 2026.