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

NCT05873725 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 118

Last updated 2025-12-09

No results posted yet for this study

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

Interventions

DRUG

Follitropin delta

Evaluation of the IVF cycle using the prescribed medication

Sponsors & Collaborators

  • Clinique Ovo

    lead INDUSTRY

Principal Investigators

  • Jacques Kadoch, MD · Clinique Ovo

Eligibility

Min Age
18 Years
Max Age
42 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-05-20
Primary Completion
2023-09-30
Completion
2024-03-19

Countries

  • Canada

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05873725 on ClinicalTrials.gov