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Intranasal Nafarelin Compared to Subcutaneous Triptorelin for Triggering Final Oocyte Maturation in Ovarian Stimulation: a Non-inferiority Randomised Controlled Clinical Trial
This is a non-inferiority randomised, controlled clinical trial comparing subcutaneous triptorelin to intranasal nafarelin for the final maturation of oocytes in oocyte donors undergoing ovarian stimulation.
Oocyte donors meeting the inclusion criteria will be randomised to receive triggering for final oocyte maturation with 200 micrograms of subcutaneous triptorelin (control group) or 800 micrograms of intranasal nafarelin (experimental group). The primary outcome is the number of mature (metaphase 2 (MII)) oocytes collected. The study has been designed with a non-inferiority limit of a difference of 2 mature oocytes, with 80% power and one-sided alpha of 0.05.
Age
18 - 35 years
Sex
FEMALE
Healthy Volunteers
No
Dexeus Mujer Sabadell
Sabadell, Barcelona, Spain
Dexeus Mujer Sant Cugat
Sant Cugat del Vallès, Barcelona, Spain
Dexeus Mujer Reus
Reus, Tarragona, Spain
Departamento de Ginecología Obstetricia y Reproducción. Hospital Universitari Dexeus
Barcelona, Spain
Start Date
March 15, 2025
Primary Completion Date
January 15, 2026
Completion Date
January 15, 2026
Last Updated
February 26, 2025
134
ESTIMATED participants
Subcutaneous Triptorelin
DRUG
Intranasal nafarelin
DRUG
Lead Sponsor
Fundacion Dexeus
NCT06928337
NCT06799507
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.
View ClinicalTrials.gov Terms and ConditionsNCT06584994