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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
154
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.
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.
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
Number of MII (metaphase 2) oocyte retrieved
Time frame: Until study completion - average of 10-20 days
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
. Participant-reported pain (measured using a visual analogue scale from 0 (no pain) to 10 (severe pain))
Time frame: Until study completion - average of 10-20 days
Medication ease of use
Medication ease of use (measured using a visual analogue scale from 0 (very easy) to 10 (very difficult))
Time frame: Until study completion - average of 10-20 days
Medication preference
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")
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Dexeus Mujer Tarragona
Tarragona, Spain
Time frame: Until study completion - average of 10-20 days
Adverse events
Time frame: Until study completion - average of 10-20 days