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Evaluating the benefit of r-hLH addition to patients with unexpected poor response: A before-and-after study

Evaluating the benefit of r-hLH addition to patients with unexpected poor response: A before-and-after study - LAPUTA study

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400086595
Enrollment
Unknown
Registered
2024-07-06
Start date
2024-11-01
Completion date
Unknown
Last updated
2025-05-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Poor ovarian response

Interventions

Single arm:Recombinant Human Follitropin Alfa Solution for Injection (Gonal-f) : Recombinant Human Lutropin alfa for Injection (Luveris) 2:1

Sponsors

Peking University Third Hospital
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
No minimum to 40 Years

Inclusion criteria

Inclusion criteria: 1) Age =1.1 ng/ml and/or AFC >=5 ; 3)Conventional protocol (GnRH agonist long or GnRH antagonist protocol) in the first IVF/ICSI cycle ; 4) r-hFSH mono form COS day 1 to day 5, with or without hMG supplementary from day 6 to trigger day for the first cycle, and the starting dose of r-hFSH is determined by the patient's AMH or AFC; 5) Number of oocytes retrieved =18.5 kg/m^2 and BMI < 28 kg/m^2.

Exclusion criteria

Exclusion criteria: 1. Unconventional COS protocols (not GnRH agonist long or GnRH antagonist protocol) ; 2. Chromosomal abnormalities or single gene disorders ; 3. PGT cycles ; 4. Previous ovarian surgery ; 5. Patients with repeated implantation failure (3 or more transfers) ; 6. Repeated pregnancy loss patients (3 or more times).

Design outcomes

Primary

MeasureTime frame
Number of oocytes retrieved;

Secondary

MeasureTime frame
Number of MII oocytes (in ICSI subgroup only) MII(ICSI) Number of MII oocytes (in ICSI subgroup only) ;Total r-hFSH dose ;Normal fertilization rate;Good-quality embryo rate at day 3;Implantation rate;Clinical pregnancy rate;Ongoing pregnancy rate;Incidence and severity of AE, SAE, and OHSS;

Countries

China

Contacts

Public ContactRong Li

Peking University Third Hospital

roseli001@sina.com+86 156 1196 8999

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026