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

Completed

• Conditions: Infertility; IVF

• Registration Number: NCT05737979
• Lead Sponsor: Clinique Ovo

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.

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 Timeline

• Study Start: 2023-01-27
• Study First Submitted: 2023-02-10
• Study First Submitted QC: 2023-02-10
• Study First Posted: 2023-02-21
• Primary Completion: 2023-11-30
• Study Completion: 2024-01-27
• Status Verified: 2024-02
• Last Update Submitted: 2024-02-16
• Last Update Posted: 2024-02-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 772

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Identify the population where a simplified IVF monitoring is conceivable	Up to 3 weeks	Rate of Rekovelle and / or Menopur dose modification before day 10 ultrasound

Trial Locations

Locations (1)

Clinique Ovo; 🇨🇦 Montréal, Quebec, Canada