Ovarian hyperstimulation syndrome (OHSS), although quite uncommon, represents the most serious complication of ovulation induction during in-vitro fertilization (IVF) protocols. The syndrome is triggered by exaggerated ovarian response to gonadotropins, which eventually leads to pathological manifestations that range from mild symptoms, such as abdominal discomfort, to life-threatening complications in the most severe cases. Prevention is paramount during fertilization programs and requires assessment of risk factors and close monitoring of risk markers. Clinicians quite generally consider unusually elevated estrogen levels as both indicator for OHSS and one possible etiological factor. In this scenario, myo-inositol (MYO) treatment proved to reduce the amount of FSH units and the duration of the stimulation protocol, decreasing the risk of OHSS onset. On the other hand, inconclusive evidence is available about the effect of D-chiro-inositol (DCI) supplementation within assisted reproductive treatments. The aim of the proposed pilot study is to assess the effect of DCI supplementation on the doses of FSH used in IVF-ET protocols, also with respect to MYO treatment.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
300
Supplementation of D-chiro-inositol (1000 mg/die), starting at least 4 weeks before rFSH administration
Supplementation of myo-inositol (4 g/die), starting at least 4 weeks before rFSH administration
Clinica Alma Res
Roma, Italy
FSH units/retrieved oocyte
number of IU of recombinant FSH administered, normalized on the number of oocytes retrieved during the pick-up
Time frame: 1 day (single time-point at ovulation)
Total FSH (IU)
total number of FSH IU used in the stimulation protocol
Time frame: 1 day (single time-point at ovulation)
Duration of the stimulation
Number of days of the stimulation protocol till pick-up
Time frame: 1 day (single time-point at ovulation)
number of viable oocytes
number of retrieved oocytes eligible for fortilization
Time frame: 1 day (single time-point at oocyte pick-up)
oocyte quality
classification of oocyte quality before fertilization
Time frame: 1 day (single time-point at oocyte pick-up)
embryo quality
evaluation of the quality of embryos after fertilization, before transfer
Time frame: 1 day (single time-point at embryo transfer)
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