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NCT05873725 Clinical Trial

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

Infertility Clinical Trial

— STORM  

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data
NCT number NCT05873725
Other study ID # 3282
Secondary ID
Status Active, not recruiting
Phase
First received
Last updated
Start date May 20, 2023
Est. completion date May 31, 2024

Study information
Verified date October 2023
Source Clinique Ovo
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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

Recruitment information / eligibility
Status Active, not recruiting
Enrollment 150
Est. completion date May 31, 2024
Est. primary completion date September 30, 2023
Accepts healthy volunteers
Gender Female
Age group 18 Years to 42 Years
Eligibility 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

Related Conditions & MeSH terms

Intervention

Drug:
• Follitropin delta
Evaluation of the IVF cycle using the prescribed medication

Locations
Country Name City State
Canada Clinique Ovo Montreal Quebec

Sponsors (1)
Lead Sponsor Collaborator
Clinique Ovo

Country where clinical trial is conducted

Canada, 

Outcome
Type Measure Description Time frame Safety issue
Primary Number of good quality blastocysts Number of good quality oocytes fertilized Up to 6 day
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