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

Sponsor
Clinique Ovo (Industry)
Overall Status
Active, not recruiting
CT.gov ID
NCT05873725
Collaborator
(none)
150
Enrollment
1
Location
12.4
Anticipated Duration (Months)
12.1
Patients Per Site Per Month

Study Details

Study Description

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

Condition or Disease Intervention/Treatment Phase
  • Drug: Follitropin delta

Study Design

Study Type:
Observational
Anticipated Enrollment :
150 participants
Observational Model:
Cohort
Time Perspective:
Retrospective
Official Title:
Retrospective Study of High Dose Follitropin Delta in a Mixed Protocol With Human Chorionic Gonadotropin
Actual Study Start Date :
May 20, 2023
Anticipated Primary Completion Date :
Aug 31, 2023
Anticipated Study Completion Date :
May 31, 2024

Arms and Interventions

Arm Intervention/Treatment
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
Evaluation of the IVF cycle using the prescribed medication
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
Evaluation of the IVF cycle using the prescribed medication

Outcome Measures

Primary Outcome Measures

  1. Number of good quality blastocysts [Up to 6 day]

    Number of good quality oocytes fertilized

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 42 Years
Sexes Eligible for Study:
Female
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Clinique Ovo Montreal Quebec Canada H4P 2S4

Sponsors and Collaborators

  • Clinique Ovo

Investigators

  • Principal Investigator: Jacques Kadoch, MD, Clinique Ovo

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Clinique Ovo
ClinicalTrials.gov Identifier:
NCT05873725
Other Study ID Numbers:
  • 3282
First Posted:
May 24, 2023
Last Update Posted:
Jun 1, 2023
Last Verified:
May 1, 2023
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Infertility
Follicle Stimulating Hormone

Study Results

No Results Posted as of Jun 1, 2023