NCT06763926

Intranasal Nafarelin For Triggering Oocyte Maturation

Intranasal Nafarelin Compared to Subcutaneous Triptorelin for Triggering Final Oocyte Maturation in Ovarian Stimulation: a Non-inferiority Randomised Controlled Clinical Trial

• Status: Not Yet Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 134 (estimated)
• Sponsor: Fundacion Dexeus · Academic / Other
• Sex: Female
• Age: 18 Years – 35 Years
• Healthy volunteers: Not accepted

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.

Detailed description

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.

Conditions

• Fertility Disorders

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2025-03-15
• Primary completion: 2026-01-15
• Completion: 2026-01-15
• First posted: 2025-01-08
• Last updated: 2025-02-26

Locations

4 sites across 1 country: Spain