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

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: Not yet recruiting
• Conditions: Infertility
• Intervention / Treatment: Other: NA，Observational study

• Study Type: Observational
• Enrollment (Estimated): 200

Contacts and Locations

• Study Contact: Name: Mengsheng Zhang; Phone Number: +86 18190952182; Email: zhangmengsheng@genscigroup.com

Study Locations

• China
  • Beijing Municipality
    • Beijing, Beijing Municipality, China, 100191
      • Peking University Third Hospital
      • Contact: Rong Li, Doctor; Phone Number: +86 13701085402; Email: roseli001@sina.com

Participation Criteria

Eligibility Criteria

• 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

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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

Outcome Measure	Time Frame
Incidence of treatment-emergent adverse events (TEAEs)	From signing the ICF to the birth of the newborn

Secondary Outcome Measures

Outcome Measure	Time Frame
Number of oocytes retrieved	Up to 22 days
Incidence of early-onset ovarian hyperstimulation syndrome (OHSS)	Up to 9 days after triggering of final follicular maturation
Incidence of moderate to severe OHSS	Up to 10-11 weeks after transfer
fetal/newborn birth defects	Up to 15 months
1-year cumulative clinical pregnancy rate per initiated stimulation cycles	4 to 6 weeks after last frozen embryo transfer
1-year cumulative ongoing pregnancy rate per initiated stimulation cycles	9 to 11 weeks after last frozen embryo transfer
1-year cumulative live birth rate per initiated stimulation cycles	more than 40 weeks after last frozen embryo transfer
β-hCG/hCG positive rate per initiated stimulation cycles with fresh embryo transfer	4 weeks after fresh embryo transfer
Clinical pregnancy rate per initiated stimulation cycles with fresh embryo transfer	4 to 6 weeks after fresh embryo transfer
Ongoing pregnancy rate per initiated stimulation cycles with fresh embryo transfer	9 to 11 weeks after fresh embryo transfer
Live birth rate per initiated stimulation cycles with 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	4 weeks after first embryo transfer
Clinical pregnancy rate per initiated stimulation cycles with first embryo transfer cycle	4 to 6 weeks after first embryo transfer
Ongoing pregnancy rate per initiated stimulation cycles with first embryo transfer cycle	9 to 11 weeks after first embryo transfer
Live birth rate per initiated stimulation cycles with first embryo transfer cycle	more than 40 weeks after first embryo transfer
Pregnancy loss rate	Up to 38 weeks after transfer
Estrogen (E₂) and progesterone (P) levels during controlled ovarian stimulation (COS)	Up to 22 days
Follicular development status	Up to 22 days
Metaphase II (MII) oocyte rate [evaluated only in intracytoplasmic sperm injection (ICSI) cycles]	Up to 22 days
Fertilization rate Implantation rate	Day 3 after oocyte retrieval
Implantation rate	Up to 28 days
High-quality embryo rate	Day 3 after oocyte retrieval
Usable blastocyst formation rate	Day 5 after oocyte retrieval

Collaborators and Investigators

• Sponsor: Changchun GeneScience Pharmaceutical Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Estimated): May 1, 2026
• Primary Completion (Estimated): August 4, 2029
• Study Completion (Estimated): December 16, 2029

Study Registration Dates

• First Submitted: April 13, 2026
• First Submitted That Met QC Criteria: April 23, 2026
• First Posted (Actual): April 28, 2026

Study Record Updates

• Last Update Posted (Actual): April 28, 2026
• Last Update Submitted That Met QC Criteria: April 23, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: assisted reproductive technology (ART); controlled ovarian stimulation (COS)
• Additional Relevant MeSH Terms: Urogenital Diseases; Genital Diseases; Infertility
• Other Study ID 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