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

Active, not recruiting

• Conditions: Infertility; IVF
• Interventions: Drug: Follitropin delta

• Registration Number: NCT05873725
• Lead Sponsor: Clinique Ovo

Brief 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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-05-15
• Study First Submitted QC: 2023-05-15
• Study Start: 2023-05-20
• Study First Posted: 2023-05-24
• Primary Completion: 2023-09-30
• Status Verified: 2023-10
• Last Update Submitted: 2023-10-30
• Last Update Posted: 2023-10-31
• Study Completion: 2024-05-31

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: Female
• Target Recruitment: 150

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Follitropin delta + hCG	Follitropin delta	Combination of follitropin delta and serial hCG injections at individualized doses, where dosing regimen was determined according to AMH and weight in women undergoing an IVF antagonist cycle
Follitropin delta + HP-hMG	Follitropin delta	Combination of follitropin delta and highly-purified human menopausal gonadotropin (HP-hMG) where dosing regimen was determined according to AMH and weight in women undergoing an IVF antagonist cycle

Primary Outcome Measures

Name	Time	Method
Number of good quality blastocysts	Up to 6 day	Number of good quality oocytes fertilized

Trial Locations

Locations (1)

Clinique Ovo; 🇨🇦 Montreal, Quebec, Canada