Modified Rekovelle and Menopur Combination Protocol to Avoid Monitoring Before Day 10 of Stimulation

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.

Study Overview

• Status: Completed
• Conditions: Infertility; IVF
• Intervention / Treatment: Other: Study chart review

Detailed Description

The purpose of this study is to evaluate the necessity of programming an ultrasound and blood test prior to the tenth day of ovarian stimulation when women are on personalized doses of Rekovelle and Menopur duting an antagonist IVF cycle. Based on the results of the analysis, we will assess the economic impact that programming an ultrasound and blood test at day 10 might have.

• Study Type: Observational
• Enrollment (Actual): 772

Contacts and Locations

Study Locations

• Canada
  • Quebec
    • Montréal, Quebec, Canada, H4P 2S4
      • Clinique ovo

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older 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 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

Exclusion Criteria:

• Second cycle of Duo-Stim IVF

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Women undergoing IVF; Women undergoing an antagonist in vitro fertilization cycle using Rekovelle and Menopur for stimulation	Other: Study chart review; Evaluation of the IVF cycle using the prescribed medication

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Clinique Ovo
• Investigators: Principal Investigator: Jacques Kadoch, MD, Clinique ovo

Study record dates

Study Major Dates

• Study Start (Actual): January 27, 2023
• Primary Completion (Actual): November 30, 2023
• Study Completion (Actual): January 27, 2024

Study Registration Dates

• First Submitted: February 10, 2023
• First Submitted That Met QC Criteria: February 10, 2023
• First Posted (Actual): February 21, 2023

Study Record Updates

• Last Update Posted (Actual): February 20, 2024
• Last Update Submitted That Met QC Criteria: February 16, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urogenital Diseases; Genital Diseases; Infertility
• Other Study ID Numbers: 3189

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No