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

NCT07553728 | Not Yet Recruiting

• 1 other identifier: GenSci094-401
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Infertility

Keywords

assisted reproductive technology (ART); controlled ovarian stimulation (COS)

Outcome Measures

Primary Outcomes (1)

• Incidence of treatment-emergent adverse events (TEAEs)

  From signing the ICF to the birth of the newborn

Secondary Outcomes (23)

• 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

Study Arms (1)

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

NA，Observational study OTHER

Data will be collected without interfering with routine clinical care.

Corifollitropin alfa N02 Injection

Eligibility Criteria

• Age: 36 Years - 40 Years
• Gender Eligibility Details: This study evaluated the safety and efficacy of Corifollitropin alfa N02 injection in at least 200 Chinese women aged 36-40 undergoing assisted reproductive technology (ART).
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• ≥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.
• 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).

Sponsors & Collaborators

• Changchun GeneScience Pharmaceutical Co., Ltd.: lead

Study Sites (1)

Peking University Third Hospital

Beijing, Beijing Municipality, 100191, China

Location

MeSH Terms

Conditions

Infertility

Condition Hierarchy (Ancestors)

Genital Diseases; Urogenital Diseases

Central Study Contacts

Mengsheng Zhang

CONTACT

+86 18190952182; zhangmengsheng@genscigroup.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 13, 2026
• First Posted: April 28, 2026
• Study Start: May 1, 2026
• Primary Completion (Estimated): August 4, 2029
• Study Completion (Estimated): December 16, 2029
• Last Updated: April 28, 2026

Record last verified: 2026-03

Locations

CN (1)