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Not yet recruitingNCT07553728Updated Apr 28, 2026

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

An observational study in Infertility, sponsored by Changchun GeneScience Pharmaceutical Co., Ltd.. Not yet recruiting at 1 site in China. Open to female participants aged 36 Years to 40 Years. Per ClinicalTrials.gov, last updated 2026-04-28.

Sponsored by Changchun GeneScience Pharmaceutical Co., Ltd. · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
200
Ages
36 Years to 40 Years
Sex
Female
01

Study 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.

02

Conditions studied

  • Infertility

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Keywords

  • assisted reproductive technology (ART)
  • controlled ovarian stimulation (COS)
03

In context

Infertility

2,506 studies on the registry are indexed under Infertility; 407 are open to participants now.

This study's planned enrollment of 200 is close to the median of 200 across 714 observational studies indexed under Infertility.

Browse Infertility studies →

Lead sponsor

Changchun GeneScience Pharmaceutical Co., Ltd. is the lead sponsor of 108 studies on the registry; 47 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
36 Years to 40 Years
Sexes eligible
Female
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.

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

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.
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
200 participants (estimated)
Patient registry
No

Groups and cohorts

  • 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

Interventions

  • OtherNA，Observational study

    Data will be collected without interfering with routine clinical care.

06

What researchers measure

Primary outcomes

  1. Incidence of treatment-emergent adverse events (TEAEs)

    Time frame: From signing the ICF to the birth of the newborn

Secondary outcomes

  1. Incidence of early-onset ovarian hyperstimulation syndrome (OHSS)

    Time frame: Up to 9 days after triggering of final follicular maturation

  2. Incidence of moderate to severe OHSS

    Time frame: Up to 10-11 weeks after transfer

  3. fetal/newborn birth defects

    Time frame: Up to 15 months

  4. 1-year cumulative clinical pregnancy rate per initiated stimulation cycles

    Time frame: 4 to 6 weeks after last frozen embryo transfer

  5. 1-year cumulative ongoing pregnancy rate per initiated stimulation cycles

    Time frame: 9 to 11 weeks after last frozen embryo transfer

  6. 1-year cumulative live birth rate per initiated stimulation cycles

    Time frame: more than 40 weeks after last frozen embryo transfer

  7. β-hCG/hCG positive rate per initiated stimulation cycles with fresh embryo transfer

    Time frame: 4 weeks after fresh embryo transfer

  8. Clinical pregnancy rate per initiated stimulation cycles with fresh embryo transfer

    Time frame: 4 to 6 weeks after fresh embryo transfer

  9. Ongoing pregnancy rate per initiated stimulation cycles with fresh embryo transfer

    Time frame: 9 to 11 weeks after fresh embryo transfer

  10. Live birth rate per initiated stimulation cycles with fresh embryo transfer

    Time frame: more than 40 weeks after fresh embryo transfer

  11. β-hCG/hCG positive rate per initiated stimulation cycles with first embryo transfer cycle

    Time frame: 4 weeks after first embryo transfer

  12. Clinical pregnancy rate per initiated stimulation cycles with first embryo transfer cycle

    Time frame: 4 to 6 weeks after first embryo transfer

  13. Ongoing pregnancy rate per initiated stimulation cycles with first embryo transfer cycle

    Time frame: 9 to 11 weeks after first embryo transfer

  14. Live birth rate per initiated stimulation cycles with first embryo transfer cycle

    Time frame: more than 40 weeks after first embryo transfer

  15. Pregnancy loss rate

    Time frame: Up to 38 weeks after transfer

  16. Number of oocytes retrieved

    Time frame: Up to 22 days

  17. Estrogen (E₂) and progesterone (P) levels during controlled ovarian stimulation (COS)

    Time frame: Up to 22 days

  18. Follicular development status

    Time frame: Up to 22 days

  19. Metaphase II (MII) oocyte rate [evaluated only in intracytoplasmic sperm injection (ICSI) cycles]

    Time frame: Up to 22 days

  20. Fertilization rate Implantation rate

    Time frame: Day 3 after oocyte retrieval

  21. Implantation rate

    Time frame: Up to 28 days

  22. High-quality embryo rate

    Time frame: Day 3 after oocyte retrieval

  23. Usable blastocyst formation rate

    Time frame: Day 5 after oocyte retrieval

07

Study locations

1 site
  • Peking University Third Hospital
    Beijing, Beijing Municipality 100191, China
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 28, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT07553728
Lead sponsor
Changchun GeneScience Pharmaceutical Co., Ltd.
Responsible party
Sponsor
First posted
Apr 28, 2026
Start date
May 1, 2026 (estimated)
Primary completion
Aug 4, 2029 (estimated)
Completion
Dec 16, 2029 (estimated)
Last update
Apr 28, 2026

Study contacts

Mengsheng Zhang
Contact
zhangmengsheng@genscigroup.com
+86 18190952182

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Mar 2026. You cannot join it, but the record below documents what was studied.

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