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NCT Number: NCT06763926

Intranasal Nafarelin For Triggering Oocyte Maturation

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.

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Key information

Conditions

Fertility Preservation

Age range

18 year–40 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

Dexeus Mujer Sabadell, Sabadell, Barcelona, Spain

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Subcutaneous Triptorelin

Drug

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 nafarelin

Drug

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.

Primary outcomes

  1. Number of MII (metaphase 2) oocyte retrieved

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

Secondary outcomes

  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

    . 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

    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

    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

Study contacts

Contact information is provided by the study sponsor or research team.

Ignacio Rodríguez, MSc

CONTACT

[email protected]

0034932274700 ext. 22029

Nikolaos P Polyzos, MD, PhD

CONTACT

[email protected]

0034932274700

Sponsors and collaborators

Lead sponsor

Fundacion Dexeus

Other

Registry information

Official study title

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

Acronym: INFORM

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Jan 8, 2025
Registry last updated
Jun 4, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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