Intranasal Nafarelin For Triggering Oocyte Maturation

NCT06763926 | Not Yet Recruiting Phase 4

• 2 other identifiers: FSD-NAF-2024-112024-516621-31-00
• Study Type: interventional
• Target: 134
• Locations: 1 country
• Sites: 4

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.

Conditions

Fertility Disorders

Keywords

IVF; Infertility; Oocyte donor; GnRH 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

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 Triptorelin DRUG

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.

Subcutaneous Triptorelin

Intranasal nafarelin DRUG

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.

Intranasal Nafarelin

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

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

Sponsors & Collaborators

• Fundacion Dexeus: lead

Study Sites (4)

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

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: 25358904 BACKGROUND

• 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: 32741721 BACKGROUND

• 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: 27114332 BACKGROUND

• 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: 19573287 BACKGROUND

Related Links

• Related Info

MeSH Terms

Conditions

Infertility

Condition Hierarchy (Ancestors)

Genital Diseases; Urogenital Diseases

Study Officials

• Nikolaos P Polyzos, MD, PhD

  Dexeus Fertility

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Nikolaos P Polyzos, MD, PhD

CONTACT

0034932274700; nikpol@dexeus.com

Ignacio Rodríguez, MSc

CONTACT

0034932274700; nacrod@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: March 15, 2025
• Primary Completion: January 15, 2026
• Study Completion: January 15, 2026
• Last Updated: February 26, 2025

Record last verified: 2025-02

Locations

ES (4)