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Fertility PreservationPhase 4INFORMNCT06763926

Intranasal Nafarelin For Triggering Oocyte Maturation

A Phase 4 study testing Subcutaneous Triptorelin and Intranasal nafarelin in people with Fertility Preservation, run by Fundacion Dexeus at 5 sites in Spain.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 to 40 years, women only
Conditions the study is for
Fertility Preservation
What is being tested?
Subcutaneous Triptorelin and Intranasal nafarelin
Could I receive a placebo?
No, everyone receives an active treatment
How many people
154 participants
Where
5 sitesSpain
Study dates
14 Oct 2026to 15 Jan 2028
Phase
Phase 4
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 40 years
  • Women only
  • No healthy volunteers
  • Adult

Who may be able to join

  • 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

Who cannot join

  • 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 locations and contacts

5 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Nikolaos P Polyzos, MD, PhD contact

0034932274700

nikpol@dexeus.com

Ignacio Rodríguez, MSc contact

0034932274700 ext. 22029

nacrod@dexeus.com

5 sites in 1 country

Spain5 sites, 5 recruiting

  • Departamento de Ginecología Obstetricia y Reproducción. Hospital Universitari Dexeus

    Barcelona, 08037

    Ignacio Rodríguez, BsC, 0034932274700 ext. 22029, nacrod@dexeus.com

    Nikolaos P Polyzos, MD PhD

    Recruiting

  • Dexeus Mujer Reus

    Reus, Tarragona, 43202

    Josep Gonzalo, MD

    Josep Gonzalo

    Not yet recruiting

  • Dexeus Mujer Sabadell

    Sabadell, Barcelona, 08203

    Silvia Grau, MD

    Silvia Grau, MD

    Not yet recruiting

  • Dexeus Mujer Sant Cugat

    Sant Cugat del Vallès, Barcelona, 08190

    Silvia Grau, MD

    Silvia Grau

    Not yet recruiting

  • Dexeus Mujer Tarragona

    Tarragona, 43206

    Josep Gonzalo, MD

    Josep Gonzalo, MD

    Not yet recruiting

Other trials in Spain

About this study

Official title: Intranasal Nafarelin Compared to Subcutaneous Triptorelin for Triggering Final Oocyte Maturation in Ovarian Stimulation: a Non-inferiority Randomised Controlled Clinical Trial

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.

Read the detailed description

Women 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 two-sided alpha of 0.05.

Being tested
Subcutaneous Triptorelin, Intranasal nafarelin
Keywords
IVF, GnRH agonist

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 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.

  • 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.

Study groups in NCT06763926
Study groupRoleWhat they receive
Subcutaneous TriptorelinActive comparator200 mcg subcutaneous triptorelin 34-36 hours prior to planned oocyte collection
Receives: Drug: Subcutaneous Triptorelin
Intranasal NafarelinActive comparator800 mcg intranasal nafarelin 36 hours prior to planned oocyte collection
Receives: Drug: Intranasal nafarelin

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of MII (metaphase 2) oocyte retrieved

    Measured: Until study completion - average of 10-20 days

Secondary outcomes (10)

  1. Total number of oocytes retrieved

    Measured: Until study completion - average of 10-20 days

  2. Incidence of ovarian hyperstimulation syndrome

    Measured: Until study completion - average of 10-20 days

  3. Serum FSH levels 10-14 hours after trigger

    Measured: 1 day after study medication

  4. Serum LH levels at time of oocyte collection

    Measured: 2 days after study medication

  5. Serum FSH levels at time of oocyte collection

    Measured: 2 days after study medication

  6. Serum progesterone levels at time of oocyte collection

    Measured: 2 days after study medication

  7. Participant-reported pain

    . Participant-reported pain (measured using a visual analogue scale from 0 (no pain) to 10 (severe pain))

    Measured: Until study completion - average of 10-20 days

  8. Medication ease of use

    Medication ease of use (measured using a visual analogue scale from 0 (very easy) to 10 (very difficult))

    Measured: Until study completion - average of 10-20 days

  9. Medication preference

    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")

    Measured: Until study completion - average of 10-20 days

  10. Adverse events

    Measured: Until study completion - average of 10-20 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Jan 2025
  2. Study start14 Oct 2026
  3. Primary completion15 Jan 2028 (estimated)
  4. Study completion15 Jan 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
154 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06763926
Sponsor's protocol ID
FSD-NAF-2024-11
Other IDs
2024-516621-31-00
Acronym
INFORM
Status last verified
Oct 2026
First submitted
17 Dec 2024
Last updated
15 Oct 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • 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.

    PubMed 25358904

  • 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).

  • 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

  • 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.

    PubMed 32741721

  • 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.

    PubMed 27114332

  • 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.

    PubMed 19573287

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Subcutaneous Triptorelin and Intranasal nafarelin in people with Fertility Preservation, run by Fundacion Dexeus at 5 sites in Spain.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 15 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Nikolaos P Polyzos, MD, PhD (0034932274700, nikpol@dexeus.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of MII (metaphase 2) oocyte retrieved (time frame: Until study completion - average of 10-20 days). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06763926, which also lists 6 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Oct 2026.

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