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Intranasal Nafarelin For Triggering Oocyte Maturation

NCT06763926 · Status: NOT_YET_RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 134

Last updated 2025-02-26

No results posted yet for this study

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.

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.

Sponsors & Collaborators

  • Fundacion Dexeus

    lead OTHER

Principal Investigators

  • Nikolaos P Polyzos, MD, PhD · Dexeus Fertility

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
35 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-03-15
Primary Completion
2026-01-15
Completion
2026-01-15

Countries

  • Spain

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06763926 on ClinicalTrials.gov