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NCT05737979 Clinical Trial

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

Infertility Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT05737979
Other study ID # 3189
Secondary ID
Status Completed
Phase
First received
Last updated
Start date January 27, 2023
Est. completion date January 27, 2024

Study information
Verified date February 2024
Source Clinique Ovo
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 772
Est. completion date January 27, 2024
Est. primary completion date November 30, 2023
Accepts healthy volunteers
Gender Female
Age group 18 Years and older
Eligibility 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

Related Conditions & MeSH terms

Intervention

Other:
• Study chart review
Evaluation of the IVF cycle using the prescribed medication

Locations
Country Name City State
Canada Clinique Ovo Montréal Quebec

Sponsors (1)
Lead Sponsor Collaborator
Clinique Ovo

Country where clinical trial is conducted

Canada, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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
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