Amount of FSH Units During Ovarian Stimulation Protocols
Conditions
Brief summary
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.
Interventions
DIETARY_SUPPLEMENTD-chiro-inositol
Supplementation of D-chiro-inositol (1000 mg/die), starting at least 4 weeks before rFSH administration
DIETARY_SUPPLEMENTMyo-inositol
Supplementation of myo-inositol (4 g/die), starting at least 4 weeks before rFSH administration
Sponsors
Lo.Li.Pharma s.r.l
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 40 Years
Healthy volunteers
Yes
Inclusion criteria
* Women undergoing IVF-ET procedure * HOMA-IR index \< 2.0 * AMH in the range 1.0 - 2.0 ng/ml
Exclusion criteria
* History of cancelled IVF cycles * BMI \< 20 kg/m2 or ≥ 30 kg/m2 * Diagnosis of PCOS * Thyroid diseases * Presence of co-morbidities
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| FSH units/retrieved oocyte | 1 day (single time-point at ovulation) | number of IU of recombinant FSH administered, normalized on the number of oocytes retrieved during the pick-up |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Total FSH (IU) | 1 day (single time-point at ovulation) | total number of FSH IU used in the stimulation protocol |
| Duration of the stimulation | 1 day (single time-point at ovulation) | Number of days of the stimulation protocol till pick-up |
| number of viable oocytes | 1 day (single time-point at oocyte pick-up) | number of retrieved oocytes eligible for fortilization |
| oocyte quality | 1 day (single time-point at oocyte pick-up) | classification of oocyte quality before fertilization |
| embryo quality | 1 day (single time-point at embryo transfer) | evaluation of the quality of embryos after fertilization, before transfer |
Countries
Italy
Outcome results
None listed