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Intranasal Nafarelin For Triggering Oocyte Maturation
Plain-language guide to NCT06763926: phase 4 randomized trial of Triptorelin and Nafarelin, 154 participants. Who took part, design and what was measured.
Key Facts
- Registry ID
- NCT06763926
- Phase
- phase 4
- Status
- recruiting participants
- Start
- 2026-10-14
- Completion (planned or actual)
- 2028-01-15
- Participants
- 154 (estimated)
- Design
- randomized, open label (everyone knows who gets what), treatment
- Conditions studied
- Fertility Preservation
- Results posted
- not yet
What This Study Did, in Plain Language
What Was Tested
In this phase 4 trial, researchers set out to test Triptorelin and Nafarelin.
It had two arms (groups): Subcutaneous Triptorelin (active comparator) and Intranasal Nafarelin (active comparator).
The registry classes the interventions as drug.
More on the Plan
The primary outcome is the number of mature (metaphase 2 (MII)) oocytes collected.
Who Took Part
The registry lists 154 planned participants were the target.
It was open to women only aged from 18 years up to 40 years.
Healthy volunteers were not accepted; participants needed the condition being studied.
Examples of who could 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.
The full record lists 3 inclusion and 5 exclusion criteria; among the exclusions: allergy or hypersensitivity to either of the study drugs; known pituitary tumour; contraindication to intranasal medication administration.
How the Study Was Run
Design: randomized, parallel-group and open-label.
The participants were allocated by chance, so the Triptorelin group and the comparison group should start out alike.
Groups ran in parallel: each of the participants stayed in one arm throughout.
Being open-label, the Triptorelin study did not mask who received what.
It started in 2026-10-14 with completion listed for 2028-01-15.
It ran at 5 sites in Spain (5).
Its stated primary purpose is treatment.
What Was Measured
The main thing measured (primary outcome): Number of MII (metaphase 2) oocyte retrieved (time frame: Until study completion - average of 10-20 days).
It also tracked 10 secondary outcomes, for example Total number of oocytes retrieved, Incidence of ovarian hyperstimulation syndrome, Serum FSH levels 10-14 hours after trigger, Serum LH levels at time of oocyte collection, Serum FSH levels at time of oocyte collection and Serum progesterone levels at time of oocyte collection.
What This Means in Plain Language
Put simply, this is a phase 4, randomized trial of Triptorelin and Nafarelin in 154 people.
It is still recruiting; no results are posted to the registry yet, so nothing here describes outcomes.
More context: the Triptorelin compound page and the Nafarelin compound page, all human trials.
Our Notes on the Compounds
Triptorelin: A 10-amino-acid GnRH analog (Trelstar, Decapeptyl, Triptodur) used in prostate cancer, early puberty and fertility protocols.
Nafarelin: A GnRH analog nasal spray (Synarel) used in endometriosis and early puberty.
Related Pages
Source: ClinicalTrials.gov record. This explanation is written by PeptideWhiz from the public record. For research and education only. Not medical advice; no dosing information is given.