Intranasal Nafarelin For Triggering Oocyte Maturation

PHASE4Not yet recruitingINTERVENTIONAL
Enrollment

134

Participants

Timeline

Start Date

March 15, 2025

Primary Completion Date

January 15, 2026

Study Completion Date

January 15, 2026

Conditions
Fertility Disorders
Interventions
DRUG

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."

DRUG

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."

Trial Locations (4)

43202

Dexeus Mujer Reus, Reus

08203

Dexeus Mujer Sabadell, Sabadell

08190

Dexeus Mujer Sant Cugat, Sant Cugat del Vallès

08037

Departamento de Ginecología Obstetricia y Reproducción. Hospital Universitari Dexeus, Barcelona

All Listed Sponsors
lead

Fundacion Dexeus

OTHER