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

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

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Key information

Conditions

IVF Genital Diseases Infertility Urogenital Diseases

Age range

18 year–42 year

Sex eligibility

Female

Study type

Observational

Primary location

Clinique Ovo

Montreal, Quebec, H4P 2S4, Canada

Who can participate

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Women 18 to 42 years of age undergoing IVF/ICSI cycle
IVF antagonist protocol
Regular menstrual cycles of 24-35 days
Presence of both ovaries

Exclusion criteria

Endometriosis stage III/IV
History of recurrent miscarriages, defined as ≥ 3 consecutive losses
Women undergoing ovarian stimulation for oncologic or elective fertility preservation
Women participating in any other research project
Hypersensitivity to follitropin delta and/or human chorionic gonadotropin
Use of Growth Hormone (GH) during the stimulation cycle

Treatment and study plan

Follitropin delta

Drug

Evaluation of the IVF cycle using the prescribed medication

Primary outcomes

Number of good quality blastocysts

Time frame: Up to 6 day

Number of good quality oocytes fertilized

Sponsors and collaborators

Lead sponsor

Clinique Ovo

Industry

Registry information

Acronym: STORM

Important dates

Study start: 2023
Primary completion: 2023
Study completion: 2024
First posted: May 24, 2023
Registry last updated: Dec 9, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed