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

Ovo Clinic

Status: Active, not recruiting

Conditions: Infertility; IVF

Treatments: Drug: Follitropin delta

Study type: Observational

Funder types: Industry

Identifiers

NCT05873725

3282

Details and patient eligibility

About

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

Enrollment: 150 estimated patients

Sex: Female

Ages: 18 to 42 years old

Volunteers: No Healthy Volunteers

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

Trial design

150 participants in 2 patient groups

Follitropin delta + hCG

Description:

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

Treatment:

Drug: Follitropin delta

Follitropin delta + HP-hMG

Description:

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

Treatment:

Drug: Follitropin delta