Clinical trial NCT06763926: Intranasal Nafarelin For Triggering Oocyte Maturation
Official title: Intranasal Nafarelin Compared to Subcutaneous Triptorelin for Triggering Final Oocyte Maturation in Ovarian Stimulation: a Non-inferiority Randomised Controlled Clinical Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE4
Conditions: Fertility Disorders
Keywords: IVF
Infertility
Oocyte donor
GnRH agonist
Lead sponsor: Fundacion Dexeus
Sponsor class: OTHER
First posted: 2025-01-08
Enrollment: 134
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a non-inferiority randomised, controlled clinical trial comparing subcutaneous triptorelin to intranasal nafarelin for the final maturation of oocytes in oocyte donors undergoing ovarian stimulation.

Detailed description: Oocyte donors 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 one-sided alpha of 0.05.

Eligibility criteria: Inclusion Criteria:

* Oocyte donor
* Undergoing a progesterone-primed ovarian stimulation cycle (PPOS) with any commercially available gonadotropin preparation(s)
* BMI 18 - 30 kg/m2
* ≥10 follicles of ≥14mm average diameter on the last ultrasound prior to trigger administration
* Able and willing to provide written informed consent

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

Primary outcomes:
measure: Number of MII (metaphase 2) oocyte retrieved
timeFrame: Until study completion - average of 10-20 days
Secondary outcomes:
measure: Total number of oocytes retrieved
timeFrame: Until study completion - average of 10-20 days
measure: Incidence of ovarian hyperstimulation syndrome
timeFrame: Until study completion - average of 10-20 days
measure: Serum FSH levels 10-14 hours after trigger
timeFrame: 1 day after study medication
measure: Serum LH levels at time of oocyte collection
timeFrame: 2 days after study medication
measure: Serum FSH levels at time of oocyte collection
timeFrame: 2 days after study medication
measure: Serum progesterone levels at time of oocyte collection
timeFrame: 2 days after study medication
measure: Participant-reported pain
timeFrame: Until study completion - average of 10-20 days
measure: Medication ease of use
timeFrame: Until study completion - average of 10-20 days
measure: Medication preference
timeFrame: Until study completion - average of 10-20 days
measure: Adverse events
timeFrame: Until study completion - average of 10-20 days
Other outcomes:
Locations:
city: Sabadell
country: Spain
facility: Dexeus Mujer Sabadell
state: Barcelona
city: Sant Cugat Del Vallès
country: Spain
facility: Dexeus Mujer Sant Cugat
state: Barcelona
city: Reus
country: Spain
facility: Dexeus Mujer Reus
state: Tarragona
city: Barcelona
country: Spain
facility: Departamento de Ginecología Obstetricia y Reproducción. Hospital Universitari Dexeus
Study officials:
affiliation: Dexeus Fertility
name: Nikolaos P Polyzos, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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).
citation: 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
citation: 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.
citation: 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.
citation: 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.