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

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)

Overview

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.

Interventions

• Other NA，Observational study
  Data will be collected without interfering with routine clinical care.

Primary outcome measures

• Incidence of treatment-emergent adverse events (TEAEs) [Time frame: From signing the ICF to the birth of the newborn]

Secondary outcome measures (12)

• 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]

Eligibility criteria

Inclusion criteria

• 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.

Exclusion criteria

• ≥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).
• 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model

Cohort

Study locations

China · 1 center

• Peking University Third Hospital — Beijing

Identifiers

NCT: NCT07553728 · GenSci094-401

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗