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Intranasal Nafarelin For Triggering Oocyte Maturation
Sponsor: Fundacion Dexeus
Summary
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.
Official title: Intranasal Nafarelin Compared to Subcutaneous Triptorelin for Triggering Final Oocyte Maturation in Ovarian Stimulation: a Non-inferiority Randomised Controlled Clinical Trial
Key Details
Gender
FEMALE
Age Range
18 Years - 35 Years
Study Type
INTERVENTIONAL
Enrollment
134
Start Date
2025-03-15
Completion Date
2026-01-15
Last Updated
2025-02-26
Healthy Volunteers
No
Conditions
Interventions
Subcutaneous Triptorelin
Oocyte donors will undergo progesterone-primed ovarian stimulation according to the standard operating protocol for the clinical unit. Specifically, on day 1 or 2 of the menstrual cycle, a transvaginal ultrasound will be performed to check the antral follicle count (AFC) and the absence of follicles \>10mm. For participants taking oral contraceptives before the treatment, the pill-free interval before starting ovarian stimulation will be 5 days. Participants will administer exogenous gonadotropins (recombinant or urinary), along with 200mg oral micronized progesterone per day for pituitary suppression. Participants using any commercially available gonadotropin preparation will be eligible for inclusion. Once 3 follicles ≥18mm are observed, participants will be randomised to one of the study arms. In the control group, 200 mcg subcutaneous triptorelin will be administered 34-36 hours prior to planned oocyte collection.
Intranasal nafarelin
Oocyte donors will undergo progesterone-primed ovarian stimulation according to the standard operating protocol for the clinical unit. Specifically, on day 1 or 2 of the menstrual cycle, a transvaginal ultrasound will be performed to check the antral follicle count (AFC) and the absence of follicles \>10mm. For participants taking oral contraceptives before the treatment, the pill-free interval before starting ovarian stimulation will be 5 days. Participants will administer exogenous gonadotropins (recombinant or urinary), along with 200mg oral micronized progesterone per day for pituitary suppression. Participants using any commercially available gonadotropin preparation will be eligible for inclusion. Once 3 follicles ≥18mm are observed, participants will be randomised to one of the study arms. In the experimental group, 800 mcg intranasal nafarelin will be administered 34-36 hours prior to planned oocyte collection.
Locations (4)
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