Inositols and FSH in IVF

Study Overview
=================
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.

Official Title
-----------------
Use of Inositols Within IVF Protocols to Reduce Gonadotropin Administration

Conditions
-----------------
Amount of FSH Units During Ovarian Stimulation Protocols

Intervention / Treatment
-----------------
* Dietary Supplement: D-chiro-inositol
* Dietary Supplement: Myo-inositol


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 40 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: comparator group<br>myo-inositol treatment | Dietary Supplement: Myo-inositol<br>* Supplementation of myo-inositol (4 g/die), starting at least 4 weeks before rFSH administration<br>|
| Experimental: study group<br>D-chiro-inositol treatment | Dietary Supplement: D-chiro-inositol<br>* Supplementation of D-chiro-inositol (1000 mg/die), starting at least 4 weeks before rFSH administration<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| FSH units/retrieved oocyte | number of IU of recombinant FSH administered, normalized on the number of oocytes retrieved during the pick-up | 1 day (single time-point at ovulation) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total FSH (IU) | total number of FSH IU used in the stimulation protocol | 1 day (single time-point at ovulation) | 
| Duration of the stimulation | Number of days of the stimulation protocol till pick-up | 1 day (single time-point at ovulation) | 
| number of viable oocytes | number of retrieved oocytes eligible for fortilization | 1 day (single time-point at oocyte pick-up) | 
| oocyte quality | classification of oocyte quality before fertilization | 1 day (single time-point at oocyte pick-up) | 
| embryo quality | evaluation of the quality of embryos after fertilization, before transfer | 1 day (single time-point at embryo transfer) |