Dual Trigger vs. GnRH-a Trigger for Elective Fertility Preservation. A randomized controlled trial.

Category Primary study
Registry of TrialsEU Clinical Trials Register
Year 2021
INTERVENTION: Trade Name: Decapeptyl diario 0,1 mg polvo y disolvente para solución inyectable Pharmaceutical Form: Solution for injection Trade Name: Decapeptyl diario 0,1 mg polvo y disolvente para solución inyectable Pharmaceutical Form: Solution for injection Trade Name: Ovitrelle 250 microgramos solución inyectable en pluma precargada. Pharmaceutical Form: CONDITION: Therapeutic area: Diseases [C] ‐ Female diseases of the urinary and reproductive systems and pregancy complications [C13] This study is a randomized controlled, superiority trial comparing the number of MII oocytes following final follicle maturation with dual trigger (250 µg rhCG + 0.2mg Triptorelin) or GnRH‐a trigger (0.2mg Triptorelin) in women undergoing elective fertility preservation. PRIMARY OUTCOME: Main Objective: To compare the number of mature oocytes (MII) retrieved after dual trigger and GnRH‐a trigger in patients undergoing elective fertility preservation in a progestin‐primed ovarian stimulation protocol. Primary end point(s): To compare the number of MII oocytes retrieved after final oocyte maturation with dual trigger and GnRH‐a trigger in patients undergoing elective fertility preservation. Secondary Objective: To compare the dual trigger and GnRH‐a trigger regarding:; 1. Total number of oocytes retrieved; 2. Endocrine profile on the day after trigger (FSH, LH, Estradiol, progesterone); 3. Incidence of OHSS Timepoint(s) of evaluation of this end point: About 34‐36 hours thereafter oocyte pick‐up will be performed. SECONDARY OUTCOME: Secondary end point(s): 1. Total number of oocytes retrieved; 2. Endocrine profile on the day after trigger (FSH, LH, estradiol, progesterone); 3. Incidence of OHSS Timepoint(s) of evaluation of this end point: Total number of oocytes retrieved:About 34‐36 hours thereafter oocyte pick‐up will be performed. ; Endocrine profile on the day after trigger; Incidence of OHSS: Untul 7 days after oocyte pick‐up INCLUSION CRITERIA: • AFC < 20 • Anti‐Mullerian hormone (AMH) = 3ng/ml (AMH result of up to one year will be valid) • Age = 40 years • BMI > 18 and < 30 kg/m2 • Willing to participate in the study Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18‐64 years) yes F.1.2.1 Number of subjects for this age range 100 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Epistemonikos ID: 0c577a53fe0f12eac5f1fcbcb58a1cf394bf8fe4
First added on: Aug 25, 2024