Intranasal Nafarelin For Triggering Oocyte Maturation

Phase 4

Not yet recruiting

• Conditions: Fertility Disorders
• Interventions: Drug: Subcutaneous Triptorelin; Drug: Intranasal nafarelin

• Registration Number: NCT06763926
• Lead Sponsor: Fundacion Dexeus

Brief 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.

Study Timeline

• Study First Submitted: 2024-12-17
• Study First Submitted QC: 2025-01-02
• Study First Posted: 2025-01-08
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-25
• Last Update Posted: 2025-02-26
• Study Start: 2025-03-15
• Primary Completion: 2026-01-15
• Study Completion: 2026-01-15

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: Female
• Target Recruitment: 134

Inclusion Criteria

• Oocyte donor
• Undergoing a progesterone-primed ovarian stimulation cycle (PPOS) with any commercially available gonadotropin preparation(s)
• BMI 18 - 30 kg/m2
• ≥10 follicles of ≥14mm average diameter on the last ultrasound prior to trigger administration
• Able and willing to provide written informed consent

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Subcutaneous Triptorelin	Subcutaneous Triptorelin	200 mcg subcutaneous triptorelin 34-36 hours prior to planned oocyte collection
Intranasal Nafarelin	Intranasal nafarelin	800 mcg intranasal nafarelin 36 hours prior to planned oocyte collection

Primary Outcome Measures

Name	Time	Method
Number of MII (metaphase 2) oocyte retrieved	Until study completion - average of 10-20 days

Secondary Outcome Measures

Name	Time	Method
Total number of oocytes retrieved	Until study completion - average of 10-20 days
Incidence of ovarian hyperstimulation syndrome	Until study completion - average of 10-20 days
Serum FSH levels 10-14 hours after trigger	1 day after study medication
Serum LH levels at time of oocyte collection	2 days after study medication
Serum FSH levels at time of oocyte collection	2 days after study medication
Serum progesterone levels at time of oocyte collection	2 days after study medication
Participant-reported pain	Until study completion - average of 10-20 days	. Participant-reported pain (measured using a visual analogue scale from 0 (no pain) to 10 (severe pain))
Medication ease of use	Until study completion - average of 10-20 days	Medication ease of use (measured using a visual analogue scale from 0 (very easy) to 10 (very difficult))
Medication preference	Until study completion - average of 10-20 days	Medication preference (measured using a 5-point Likert scale from (a) "I would strongly prefer the nasal spray" to (e) "I would strongly prefer the injection")
Adverse events	Until study completion - average of 10-20 days

Trial Locations

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