GnRHa Trigger in Asian Oocyte Donors- a Dose Finding Study
Condition: Normal Oocyte Donors
Study type: Interventional

Summary: 
      The aim of this randomized single center study is to explore the most optimal dose of GnRHa
      used for triggering of final oocyte maturation in IVF. The study group will consist of oocyte
      donors who have GnRHa trigger as a standard trigger concept.

      Hypothesis: In an Asian oocyte donor population, the use of 0.2 mg, 0.3mg or 0.4 mg of GnRHa
      will lead to the retrieval of comparable numbers of mature oocytes (MII) and good quality
      embryos. Moreover, the reproductive outcome in the recipients will be similar regardless of
      the dose of GnRHa used for trigger.
    

Detailed description: 
      Methods

      A randomized controlled single center study. All oocyte donors, fulfilling the inclusion
      criteria, will be eligible for inclusion after randomization.

      Stimulation, monitoring, oocyte pick-up in donors and embryo transfer in recipients On day
      two of the cycle, - i.e. prior to commencing stimulation with long acting FSH (Elonva) -
      donors will be randomized to one of three groups, using different doses of GnRHa
      (Triptorelin) for trigger. Stimulation will be performed according to the standard
      stimulation protocol of the clinic, using Elonva followed by co-treatment with a GnRH
      antagonist from day 5 of stimulation . The dose of Elonva used for stimulation will be either
      100 or 150 µg according to the weight of the patient. The first transvaginal ultrasound scan
      (TVUS) will be performed after seven or eight days after the Elonva depot injection. As soon
      as two follicles have reached a size of ≥ 17mm, triggering of final oocyte maturation will be
      performed with one single bolus of Triptorelin, 0.2 mg, 0.3mg or 0.4 mg. The timing of the
      trigger will be 6 AM for all groups and the oocyte pick-up (OPU) will be performed after 34
      hours, according to the usual practice of the clinic. Importantly, each patient will be asked
      to check the presence of an LH surge via a urine LH detection kit at 4 hours after the
      trigger bolus has been administered. Embryo transfer will be performed on day two in all
      recipients.

      Study group I Stimulation according to the abovementioned and ovulation trigger with 0.2mg
      Triptorelin. All other procedures will be performed according to the practice of the clinic.

      Study group II Stimulation according to the abovementioned and ovulation trigger with 0.3mg
      Triptorelin. All other procedures will be performed according to the practice of the clinic.

      Study group III Stimulation according to the abovementioned and ovulation trigger with 0.4mg
      Triptorelin. All other procedures will be performed according to the practice of the clinic.

      Randomization Randomization will be performed using sealed envelopes developed via a computer
      generated list with blocks of twelve. The randomization will be performed on day two of the
      cycle. Doctors will be blinded to the randomization, but not patients and nurses.

      Follicular fluid (FF) collection FF from the first punctured follicle on each side will be
      collected and cryo-preserved at -20 degrees for subsequent analysis of steroids.

      Granulosa cell gene-expression analysis Cumulus and mural granulosa cells will be preserved
      and snap-frozen from a sub-group of 10 patients in each group. The primary subsequent
      analysis will focus on possible differences in LHR gene expression according to GnRHa trigger
      dose.
    

Intervention name(s): Triptorelin
Intervention type(s): Drug
Intervention description(s): Triptorelin is given by s.c injection for ovulation triggering.
Other intervention name(s): Diphereline 0.1 mg powder and solvent
Intervention MeSH terms: Triptorelin Pamoate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: GnRH antagonist; GnRH agonist trigger; Oocyte donor