Intranasal Nafarelin For Triggering Oocyte Maturation (INFORM)

Fundacion Dexeus

Status and phase: Not yet enrolling; Phase 4

Conditions: Fertility Disorders

Treatments: Drug: Intranasal nafarelin; Drug: Subcutaneous Triptorelin

Study type: Interventional

Funder types: Other

Identifiers

NCT06763926

FSD-NAF-2024-11

2024-516621-31-00 (EU Trial (CTIS) Number)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 134 estimated patients

Sex: Female

Ages: 18 to 35 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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134 participants in 2 patient groups

Subcutaneous Triptorelin

Active Comparator group

Description:

200 mcg subcutaneous triptorelin 34-36 hours prior to planned oocyte collection

Treatment:

Drug: Subcutaneous Triptorelin

Intranasal Nafarelin

Active Comparator group

Description:

800 mcg intranasal nafarelin 36 hours prior to planned oocyte collection

Treatment:

Drug: Intranasal nafarelin