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

October 30, 2023 updated by: Clinique Ovo
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

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

150

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

N/A

Sampling Method

Non-Probability Sample

Study Population

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

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of good quality blastocysts
Time Frame: Up to 6 day
Number of good quality oocytes fertilized
Up to 6 day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Clinique Ovo

Investigators

  • Principal Investigator: Jacques Kadoch, MD, Clinique OVO

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 20, 2023

Primary Completion (Actual)

September 30, 2023

Study Completion (Estimated)

May 31, 2024

Study Registration Dates

First Submitted

May 15, 2023

First Submitted That Met QC Criteria

May 15, 2023

First Posted (Actual)

May 24, 2023

Study Record Updates

Last Update Posted (Actual)

October 31, 2023

Last Update Submitted That Met QC Criteria

October 30, 2023

Last Verified

October 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 3282

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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