NCT05873725

Retrospective Study of High Dose Follitropin Delta in a Mixed Protocol With Human Chorionic Gonadotropin

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 118 (actual)
• Sponsor: Clinique Ovo · Industry
• Sex: Female
• Age: 18 Years – 42 Years
• Healthy volunteers: —

Summary

Follitropin delta is a rFSH, uniquely expressed in a human fetal retinal cell line, which owing to differences in glycosylation profile has a lower clearance and induces a higher ovarian response in humans than existing rFSH preparations when administered at equal doses of biological activity. A noninferiority clinical trial (ESTHER-1) in which individualized dosage of follitropin delta according to each patient's profile (AMH and weight) was compared to conventional follitropin alfa dosing for IVF have demonstrated that an individualized follitropin delta dosing is noninferior to conventional follitropin alfa with respect to ongoing pregnancy rate, ongoing implantation rate, and also live births, with a concomitant reduction in iatrogenic complications, including OHSS

Conditions

• IVF
• Infertility

Interventions

Type	Name	Description
DRUG	Follitropin delta	Evaluation of the IVF cycle using the prescribed medication

Timeline

• Start date: 2023-05-20
• Primary completion: 2023-09-30
• Completion: 2024-03-19
• First posted: 2023-05-24
• Last updated: 2025-12-09

Locations

1 site across 1 country: Canada