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

NCT ID: NCT05873725

Last Updated: 2025-12-09

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 118 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2023-05-20
• Study Completion Date: 2024-03-19

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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: RETROSPECTIVE

Study Groups

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

Follitropin delta

Intervention Type: DRUG

Evaluation of the IVF cycle using the prescribed medication

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

Follitropin delta

Intervention Type: DRUG

Evaluation of the IVF cycle using the prescribed medication

Interventions

Follitropin delta

Evaluation of the IVF cycle using the prescribed medication

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 42 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Clinique Ovo

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jacques Kadoch, MD

Role: PRINCIPAL_INVESTIGATOR

Clinique Ovo

Locations

Clinique Ovo

Montreal, Quebec, Canada

Countries

Canada

Other Identifiers

3282

Identifier Type: -

Identifier Source: org_study_id