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Trial · Interventional

RecruitingPhase 4Registry data

Intranasal Nafarelin For Triggering Oocyte Maturation

Short name INFORM

NCTNCT06763926 (opens ClinicalTrials.gov in a new tab)Other idFSD-NAF-2024-11Other id2024-516621-31-00
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Recruiting
Phase
Phase 4
Enrollment
154 participants (estimated)
Sponsor
Fundacion Dexeus · Other
Design
Randomized · Open label (no masking)
Countries
1 country

Spain

Start
14 Oct 2026
Primary completion
15 Jan 2028 (estimated)
Completion
15 Jan 2028 (estimated)
First posted
8 Jan 2025
Last update posted
15 Oct 2026
Conditions
Fertility Preservation

Timeline

1 trial · 1 ongoing

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
2026202720282029
  1. Ph 4

    INFORM

    NCT06763926

    14 Oct 2026 to est. 15 Jan 2028

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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.

Interventions

  • Subcutaneous TriptorelinDrug
  • Intranasal nafarelinDrug

Arms2

  • Active comparator

    Subcutaneous Triptorelin

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

  • Active comparator

    Intranasal Nafarelin

    800 mcg intranasal nafarelin 36 hours prior to planned oocyte collection

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. Number of MII (metaphase 2) oocyte retrieved

    Time frame · Until study completion - average of 10-20 days

Secondary outcomes(10)

  1. Total number of oocytes retrieved

    Time frame · Until study completion - average of 10-20 days

  2. Incidence of ovarian hyperstimulation syndrome

    Time frame · Until study completion - average of 10-20 days

  3. Serum FSH levels 10-14 hours after trigger

    Time frame · 1 day after study medication

  4. Serum LH levels at time of oocyte collection

    Time frame · 2 days after study medication

  5. Serum FSH levels at time of oocyte collection

    Time frame · 2 days after study medication

  6. Serum progesterone levels at time of oocyte collection

    Time frame · 2 days after study medication

  7. Participant-reported pain

    Time frame · Until study completion - average of 10-20 days

    Registry description

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

  8. Medication ease of use

    Time frame · Until study completion - average of 10-20 days

    Registry description

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

  9. Medication preference

    Time frame · Until study completion - average of 10-20 days

    Registry description

    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")

  10. Adverse events

    Time frame · Until study completion - average of 10-20 days

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

A trial that is still running, or that stopped early, may post results later.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies2

Studies that cite this trial.

More studies

2 studies on this page

PubMed tag: none · 2020

GnRHa for trigger and luteal phase support in natural cycle frozen embryo transfer - A proof of concept study.

Bar Hava et al. 2020Reproductive biologycited by 6

PMID 32741721DOI 10.1016/j.repbio.2020.07.009PUB-32741721

Full text at the publisher
Publisher page

PubMed tag: none · 2016

Intranasal gonadotropin-releasing hormone agonist (GnRHa) for luteal-phase support following GnRHa triggering, a novel approach to avoid ovarian hyperstimulation syndrome in high responders.

Bar-Hava et al. 2016Fertility and sterilitycited by 29

PMID 27114332DOI 10.1016/j.fertnstert.2016.04.004PUB-27114332

Full text at the publisher
Publisher page

Eligibility

Who could join, as posted.

Sex
Female
Age
from 18 Years up to 40 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
Inclusion Criteria: * 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 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

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