NCT06763926

Brief 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.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
154

participants targeted

Target at P50-P75 for phase_4

Timeline
17mo left

Started Jun 2026

Geographic Reach
1 country

5 active sites

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress9%
Jun 2026Jan 2028

First Submitted

Initial submission to the registry

December 17, 2024

Completed
22 days until next milestone

First Posted

Study publicly available on registry

January 8, 2025

Completed
1.4 years until next milestone

Study Start

First participant enrolled

June 15, 2026

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 15, 2028

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 15, 2028

Last Updated

June 4, 2026

Status Verified

June 1, 2026

Enrollment Period

1.6 years

First QC Date

December 17, 2024

Last Update Submit

June 2, 2026

Conditions

Fertility Preservation

Keywords

IVFGnRH agonist

Outcome Measures

Primary Outcomes (1)

  • Number of MII (metaphase 2) oocyte retrieved

    Until study completion - average of 10-20 days

Secondary Outcomes (10)

  • 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

  • +5 more secondary outcomes

Study Arms (2)

Subcutaneous Triptorelin

ACTIVE COMPARATOR

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

Drug: Subcutaneous Triptorelin

Intranasal Nafarelin

ACTIVE COMPARATOR

800 mcg intranasal nafarelin 36 hours prior to planned oocyte collection

Drug: Intranasal nafarelin

Interventions

Subcutaneous TriptorelinDRUG

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.

Subcutaneous Triptorelin
Intranasal nafarelinDRUG

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.

Intranasal Nafarelin

Eligibility Criteria

Age18 Years - 40 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • Allergy or hypersensitivity to either of the study drugs
  • Hypopituitarism
  • Known pituitary tumour
  • Contraindication to intranasal medication administration
  • Previous poor response to agonist trigger

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Dexeus Mujer Sabadell

Sabadell, Barcelona, 08203, Spain

Location

Dexeus Mujer Sant Cugat

Sant Cugat del Vallès, Barcelona, 08190, Spain

Location

Dexeus Mujer Reus

Reus, Tarragona, 43202, Spain

Location

Departamento de Ginecología Obstetricia y Reproducción. Hospital Universitari Dexeus

Barcelona, 08037, Spain

Location

Dexeus Mujer Tarragona

Tarragona, 43206, Spain

Location

Related Publications (6)

  • Youssef MA, Van der Veen F, Al-Inany HG, Mochtar MH, Griesinger G, Nagi Mohesen M, Aboulfoutouh I, van Wely M. Gonadotropin-releasing hormone agonist versus HCG for oocyte triggering in antagonist-assisted reproductive technology. Cochrane Database Syst Rev. 2014 Oct 31;2014(10):CD008046. doi: 10.1002/14651858.CD008046.pub4.

    PMID: 25358904BACKGROUND

  • V. Donno, A. R. Neves, S. Garcia Martinez, N. P. Polyzos. O-074 Dual trigger is not superior to GnRH Agonist alone for final oocyte maturation in elective fertility preservation. A Randomized Controlled Trial. Hum Reprod. 2024;39(Supp 1).

    BACKGROUND

  • Davenport MJ, MacLachlan VB, Vollenhoven BJ, Talmor AJ, Healey M. How we trigger matters: intranasal GnRH-agonist trigger may reduce oocyte maturation compared to subcutaneous administration in ICSI cycles. Fertility and Sterility. 2019

    BACKGROUND

  • Bar Hava I, Yafee H, Omer Y, Humaidan P, Ganer Herman H. GnRHa for trigger and luteal phase support in natural cycle frozen embryo transfer - A proof of concept study. Reprod Biol. 2020 Sep;20(3):282-287. doi: 10.1016/j.repbio.2020.07.009. Epub 2020 Jul 30.

    PMID: 32741721BACKGROUND

  • Bar-Hava I, Mizrachi Y, Karfunkel-Doron D, Omer Y, Sheena L, Carmon N, Ben-David G. Intranasal gonadotropin-releasing hormone agonist (GnRHa) for luteal-phase support following GnRHa triggering, a novel approach to avoid ovarian hyperstimulation syndrome in high responders. Fertil Steril. 2016 Aug;106(2):330-3. doi: 10.1016/j.fertnstert.2016.04.004. Epub 2016 Apr 22.

    PMID: 27114332BACKGROUND

  • Golan A, Weissman A. Symposium: Update on prediction and management of OHSS. A modern classification of OHSS. Reprod Biomed Online. 2009 Jul;19(1):28-32. doi: 10.1016/s1472-6483(10)60042-9.

    PMID: 19573287BACKGROUND

Related Links

Study Officials

  • Nikolaos P Polyzos, MD, PhD

    Dexeus Fertility

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Nikolaos P Polyzos, MD, PhD

CONTACT

0034932274700nikpol@dexeus.com

Ignacio Rodríguez, MSc

CONTACT

0034932274700nacrod@dexeus.com

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 17, 2024

First Posted

January 8, 2025

Study Start

June 15, 2026

Primary Completion (Estimated)

January 15, 2028

Study Completion (Estimated)

January 15, 2028

Last Updated

June 4, 2026

Record last verified: 2026-06

Locations

ES(5)