Safety and Efficacy of Corifollitropin Alfa N02 Injection in Elderly Women Undergoing Assisted Reproductive Technology (ART)

April 23, 2026 updated by: Changchun GeneScience Pharmaceutical Co., Ltd.

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
200

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • China
    • Beijing Municipality
      • Beijing, Beijing Municipality, China, 100191
        • Peking University Third Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Married women aged 35-39 years scheduled for controlled ovarian stimulation (COS) and IVF/ICSI assisted reproduction using a fixed antagonist protocol with Corifollitropin alfa N02 Injection.

Description

Inclusion Criteria:

  1. Able to communicate well with investigators, understand and comply with trial requirements, participate voluntarily, and provide signed informed consent after full understanding.
  2. Married women aged 36 to 40 years (exclusive of boundary values).
  3. Normal ovarian function: AMH ≥ 1.1 μg/L and basal FSH < 10 IU/L.
  4. Scheduled to undergo controlled ovarian stimulation (COS) and IVF/ICSI using a fixed antagonist protocol combined with Corifollitropin alpha N02 injection.

Exclusion Criteria:

  1. ≥3 previous cycles of controlled ovarian stimulation (COS)
  2. Recurrent pregnancy loss: ≥3 previous pregnancy losses (including spontaneous abortion, biochemical pregnancy, and missed abortion).
  3. 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.

  4. 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.

  5. 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.

  6. Presence of any reproductive, endocrine, or immune disorders that may affect pregnancy, as assessed by the investigator.
  7. Abnormal uterine bleeding.
  8. 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.
  9. 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.
  10. History of alcoholism, heavy smoking, drug addiction, or substance abuse.
  11. Scheduled to undergo preimplantation genetic testing (PGT).
  12. Currently participating in another clinical trials and receiving investigational products.
  13. Any other conditions deemed by the investigator to render the subject unsuitable for trial participation based on safety considerations.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Corifollitropin alfa N02 Injection
Observe and record the safety and efficacy data of women receiving controlled ovarian stimulation therapy using Corifollitropin alfa N02 Injection
Other: NA，Observational study
Data will be collected without interfering with routine clinical care.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Incidence of treatment-emergent adverse events (TEAEs)
Time Frame: From signing the ICF to the birth of the newborn
From signing the ICF to the birth of the newborn

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Number of oocytes retrieved
Time Frame: Up to 22 days
Up to 22 days
Incidence of early-onset ovarian hyperstimulation syndrome (OHSS)
Time Frame: Up to 9 days after triggering of final follicular maturation
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
Up to 10-11 weeks after transfer
fetal/newborn birth defects
Time Frame: Up to 15 months
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
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
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
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
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
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
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
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
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
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
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
more than 40 weeks after first embryo transfer
Pregnancy loss rate
Time Frame: Up to 38 weeks after transfer
Up to 38 weeks after transfer
Estrogen (E₂) and progesterone (P) levels during controlled ovarian stimulation (COS)
Time Frame: Up to 22 days
Up to 22 days
Follicular development status
Time Frame: Up to 22 days
Up to 22 days
Metaphase II (MII) oocyte rate [evaluated only in intracytoplasmic sperm injection (ICSI) cycles]
Time Frame: Up to 22 days
Up to 22 days
Fertilization rate Implantation rate
Time Frame: Day 3 after oocyte retrieval
Day 3 after oocyte retrieval
Implantation rate
Time Frame: Up to 28 days
Up to 28 days
High-quality embryo rate
Time Frame: Day 3 after oocyte retrieval
Day 3 after oocyte retrieval
Usable blastocyst formation rate
Time Frame: Day 5 after oocyte retrieval
Day 5 after oocyte retrieval

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Changchun GeneScience Pharmaceutical Co., Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 1, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 4, 2029

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 16, 2029

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 13, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 23, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 28, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 28, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 23, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • GenSci094-401

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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