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Clinical Trials in Spain / NCT06763926
Starting soon Phase 4

Intranasal Nafarelin For Triggering Oocyte Maturation

NCT06763926 · tracked via the Priya Life Science Spain tracker
Sponsor
Fundacion Dexeus
Phase
Phase 4
Started
2026-10-15
Last updated
2026-09-03

Condition(s) studied

Fertility Preservation

Investigational drug(s) / intervention(s)

Subcutaneous Triptorelin →Intranasal nafarelin

Subcutaneous Triptorelin: Women undergoing fertility preservation will undergo progesterone-primed ovarian stimulation according to the standard operating protocol for the clinical unit.. 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. n the control group, 200 mcg subcutaneous triptorelin will be administered 34-36 hours prior to planned oocyte collection.

Intranasal nafarelin: Women undergoing fertility preservation will undergo progesterone-primed ovarian stimulation according to the standard operating protocol for the clinical unit. 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.

Study summary

This is a non-inferiority randomised, controlled clinical trial comparing subcutaneous triptorelin to intranasal nafarelin for the final maturation of oocytes in women undergoing fertility preservation cycles with oocyte cryopreservation undergoing ovarian stimulation.

Eligibility

Sex
FEMALE
Min age
18 Years
Max age
40 Years
Healthy volunteers
No
Inclusion Criteria: * Women undergoing fertility preservation cycles with oocyte cryopreservation * Undergoing a progesterone-primed ovarian stimulation cycle (PPOS) with any commercially available gonadotropin preparation(s) * BMI 18 - 30 kg/m2 Exclusion Criteria: * Allergy or hypersensitivity to either of the study drugs * Hypopituitarism * Known pituitary tumour * Contraindication to intranasal medication administration * Previous poor response to agonist trigger

Primary outcome measure(s)

Trial sites (5)

FacilityCityRegionStatus
Dexeus Mujer Sabadell Sabadell Barcelona
Dexeus Mujer Sant Cugat Sant Cugat del Vallès Barcelona
Dexeus Mujer Reus Reus Tarragona
Departamento de Ginecología Obstetricia y Reproducción. Hospital Universitari Dexeus Barcelona Spain
Dexeus Mujer Tarragona Tarragona Spain

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Embryo QUAlity in Ovarian Stimulation With hMG. Starting soon
Ultra-rapid Blastocyst Vitrification: Pilot Randomized Study Recruiting
AI-TOP Study Artificial Intelligence for Trigger Optimization. Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06763926 on ClinicalTrials.gov ↗ ← All trials in Spain