Trial Comparing Start Stimulation of Recombinant Follicle Stimulating Hormone (rFSH) on Cycle Day 2 Versus Cycle Day 5 in In Vitro Fertilization (IVF)
Condition: in Vitro Fertilization; Ovulation Induction
Intervention: Mild stimulation
Intervention description: Fixed daily dose of 150 IU rFSH start cycle day 5 or day 2 depending on the Arm
Intervention MeSH terms: Ganirelix
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 147.0
Sex: Female
Minimum age: 18 Years
Maximum age: 36 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: embryonic structures; sperm injections, intracytoplasmic; IVF; GnRH antagonist; ovarian stimulation; cycle day 2 versus cycle day 5

Summary:

      Background of the study:

      Milder stimulation protocols have the advantage of being less expensive and more
      patient-friendly. Moreover, recent evidence suggests that mild stimulation protocols lead to
      lower embryo aneuploidy rates compared to conventional treatment regimens. Although with mild
      stimulation protocols the expected number of oocytes retrieved will be lower, pregnancy rates
      have shown to be similar possibly because embryo quality outfavours embryo quantity.

      Objective of the study:

      The aim of the study is to determine whether cycle day (CD) 5 start of stimulation will lead
      to better quality of embryos, based on morphology, than CD 2 start, in IVF with GnRH
      antagonist co-treatment started on a fixed day.

      Study design:

      Prospective randomized trial comparing two different starting days of ovarium stimulation
      (day 2 versus day 5) for IVF treatment.

      Intervention:

      One group wil start on cycle day 2 with stimulation of the ovaries with recombinant FSH. The
      other group will start on cycle day 5. Both group will start suppressing the gonadotrophin
      production of the the pituitary gland on cycle day 6 with a GnRH antagonist.

      Primary study parameters/outcome of the study:

      Primary outcome parameter is number of top embryos per ovum pick up.

      Secondary study parameters/outcome of the study:

      Secondary outcome measures are duration of stimulation, cancellation rate, fertilization
      rate, number of cumulus oocyte complexes obtained, number of mature oocytes obtained, number
      of top embryos per started cycle, amount of IU recFSH, and clinical pregnancy rate.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Female age < 36 years

          -  FSH < 12 IU/l

          -  BMI 18-29 kg/m2

          -  Regular cycle (25-35 days)

          -  No major uterine or ovarian abnormalities

          -  No previous IVF cycles

          -  Written informed consent

        Exclusion Criteria:

          -  Oocyte donation

          -  Medical contra indication for pregnancy or IVF treatment

          -  Endometriosis ≥ grade 3

          -  Polycystic Ovarium Syndrome (PCOS)

          -  Endocrine or metabolic abnormalities (pituitary, adrenal, pancreas, liver or kidney)