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NCT06763926·Phase 4·INTERVENTIONAL

Intranasal Nafarelin For Triggering Oocyte Maturation

TriptorelinOtherNot yet recruiting

Status

Not yet recruiting

Phase

Phase 4

Enrollment

154

Locations

5

Results

Not posted

Publications

4

Study summary

What the protocol is testing.

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.

Full 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.

Interventions

Treatment arms and agents.

DRUG

Subcutaneous Triptorelin

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.

DRUG

Intranasal nafarelin

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.

Timeline

From registration to results.

  1. First posted

    Jan 8, 2025

  2. Study start

    Jun 15, 2026

  3. Primary completion

    Jan 15, 2028

  4. Study completion

    Jan 15, 2028

  5. Results posted

    Not reported

  6. Registry updated

    Jun 4, 2026

Outcomes

What the study measures.

Primary outcomes

Number of MII (metaphase 2) oocyte retrieved

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

Secondary outcomes

Total number of oocytes retrieved

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

Incidence of ovarian hyperstimulation syndrome

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

Serum FSH levels 10-14 hours after trigger

Time frame · 1 day after study medication

Serum LH levels at time of oocyte collection

Time frame · 2 days after study medication

Serum FSH levels at time of oocyte collection

Time frame · 2 days after study medication

Serum progesterone levels at time of oocyte collection

Time frame · 2 days after study medication

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))

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))

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")

Adverse events

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

Eligibility

Who can take part.

Minimum age
18 Years
Maximum age
40 Years
Sex
FEMALE
Healthy volunteers
No

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

Study locations

5 registered sites.

Spain. Showing up to 24 locations stored in the fast local snapshot.

Dexeus Mujer Sabadell

Sabadell, Barcelona, Spain

Dexeus Mujer Sant Cugat

Sant Cugat del Vallès, Barcelona, Spain

Dexeus Mujer Reus

Reus, Tarragona, Spain

Departamento de Ginecología Obstetricia y Reproducción. Hospital Universitari Dexeus

Barcelona, Spain

Dexeus Mujer Tarragona

Tarragona, Spain

Publications

Results and literature.

PMID 25358904 ↗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 32741721 ↗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 27114332 ↗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 19573287 ↗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.

Primary links

Continue at the source.

ClinicalTrials.gov ↗Search PubMed ↗Search FDA ↗Search EMA ↗

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