NCT05737979

Brief Summary

Follitropin delta (Rekovelle) algorithm established by Ferring provides personalized gonadotrophin doses based on each patient's weight and AMH. As a result, risks of stimulation failure or ovarian hyperstimulation syndrome (OHSS) during an in vitro fertilization (IVF) cycle are minimized. As a standard practice for OHSS prevention at clinique ovo, women undergoing IVF will have a scheduled ultrasound and blood test on the sixth day of their stimulation treatment. However, with the determination of the Rekovelle and Menopur algorithm, the risks of OHSS before the tenth day have been considerably minimized.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
772

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2023

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 27, 2023

Completed
14 days until next milestone

First Submitted

Initial submission to the registry

February 10, 2023

Completed
11 days until next milestone

First Posted

Study publicly available on registry

February 21, 2023

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2023

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 27, 2024

Completed
Last Updated

February 20, 2024

Status Verified

February 1, 2024

Enrollment Period

10 months

First QC Date

February 10, 2023

Last Update Submit

February 16, 2024

Conditions

InfertilityIVF

Outcome Measures

Primary Outcomes (1)

  • Identify the population where a simplified IVF monitoring is conceivable

    Rate of Rekovelle and / or Menopur dose modification before day 10 ultrasound

    Up to 3 weeks

Study Arms (1)

Women undergoing IVF

Women undergoing an antagonist in vitro fertilization cycle using Rekovelle and Menopur for stimulation

Other: Study chart review

Interventions

Study chart reviewOTHER

Evaluation of the IVF cycle using the prescribed medication

Women undergoing IVF

Eligibility Criteria

Age18 Years+
Sexfemale(Gender-based eligibility)
Gender Eligibility Detailsin vitro fertilization can only be done on women as we have to stimulate ovaries
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • Women of 18 years of age or older having provided consent to chart access for scientific publication in the IVF consent form
  • Antagonist IVF cycle using combination of Rekovelle and Menopur for stimulation according to the modified protocol employed at clinique ovo without deviation
  • Presence of both ovaries

You may not qualify if:

  • Second cycle of Duo-Stim IVF

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Clinique Ovo

Montreal, Quebec, H4P 2S4, Canada

Location

MeSH Terms

Conditions

Infertility

Condition Hierarchy (Ancestors)

Genital DiseasesUrogenital Diseases

Study Officials

  • Jacques Kadoch, MD

    Clinique Ovo

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 10, 2023

First Posted

February 21, 2023

Study Start

January 27, 2023

Primary Completion

November 30, 2023

Study Completion

January 27, 2024

Last Updated

February 20, 2024

Record last verified: 2024-02

Data Sharing

IPD Sharing
Will not share

Locations

CA(1)