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

NCT05873725 | Completed

• 1 other identifier: 3282
• Study Type: observational
• Target: 118
• Locations: 1 country
• Sites: 1

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

Conditions

IVF; Infertility

Outcome Measures

Primary Outcomes (1)

• Number of good quality blastocysts

  Number of good quality oocytes fertilized

  Up to 6 day

Study Arms (2)

Follitropin delta + hCG

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

Drug: Follitropin delta

Follitropin delta + HP-hMG

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

Drug: Follitropin delta

Interventions

Follitropin delta DRUG

Evaluation of the IVF cycle using the prescribed medication

Follitropin delta + HP-hMG; Follitropin delta + hCG

Eligibility Criteria

• Age: 18 Years - 42 Years
• Sex: female
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Women consulting the clinic for fertility issues that require in vitro fertilization

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Clinique Ovo: lead

Study Sites (1)

Clinique Ovo

Montreal, Quebec, H4P 2S4, Canada

Location

MeSH Terms

Conditions

Infertility

Interventions

follitropin delta

Condition Hierarchy (Ancestors)

Genital Diseases; Urogenital Diseases

Study Officials

• Jacques Kadoch, MD

  Clinique Ovo

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 15, 2023
• First Posted: May 24, 2023
• Study Start: May 20, 2023
• Primary Completion: September 30, 2023
• Study Completion: March 19, 2024
• Last Updated: December 9, 2025

Record last verified: 2025-12

Locations

CA (1)