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Extended LH administration (ELHA), a strategy to increase the pool of recruitable antral follicles: a multicentric randomized trial

Status
Recruiting
Phases
Phase 2
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2024-517407-36-00
Enrollment
84
Registered
2024-11-25
Start date
2024-11-12
Completion date
Unknown
Last updated
2025-09-12

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

Conditions

male factor or for idiopathic infertility., Patients admitted to an IVF/ICSI cycle will be included. The patient will be addresses to the IVF cycles for the following reasons: tubal factor

Brief summary

The primary endpoint of the study will be to confirm that the pre-treatment with rhLH at the dose of 187.5 IU/day for 60 days may improve ovarian reserve as indicated by an increase in basal AMH.

Detailed description

• Change of AFC after 30/60 days • Change of AMH after 30 days • Ovarian response • Evaluate the safety of rLH • cycles discontinued/cancelled before rhCG administration • percent of missed transfer of fresh embryos • implantation rate • biochemical pregnancy rate • clinical pregnancy rate • early and late OHSS rate • miscarriage rate • preterm birth rate • low birth weight rate • congenital anomalies rate • gestational age at delivery • mean neonatal weight

Interventions

DRUGLuveris 75 IU powder and solvent for solution for injection

Sponsors

Azienda Ospedaliero Universitaria Di Modena
Lead SponsorOTHER

Eligibility

Sex/Gender
All
Age
18 Years to 64 Years

Design outcomes

Primary

MeasureTime frame
The primary endpoint of the study will be to confirm that the pre-treatment with rhLH at the dose of 187.5 IU/day for 60 days may improve ovarian reserve as indicated by an increase in basal AMH.

Secondary

MeasureTime frame
• Change of AFC after 30/60 days • Change of AMH after 30 days • Ovarian response • Evaluate the safety of rLH • cycles discontinued/cancelled before rhCG administration • percent of missed transfer of fresh embryos • implantation rate • biochemical pregnancy rate • clinical pregnancy rate • early and late OHSS rate • miscarriage rate • preterm birth rate • low birth weight rate • congenital anomalies rate • gestational age at delivery • mean neonatal weight

Countries

Italy

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026