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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| comparator group | Active Comparator | myo-inositol treatment |
|
| study group | Experimental | D-chiro-inositol treatment |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| D-chiro-inositol | Dietary Supplement | Supplementation of D-chiro-inositol (1000 mg/die), starting at least 4 weeks before rFSH administration |
|
| 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) |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinica Alma Res | Roma | 00198 | Italy |
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| ID | Term |
|---|---|
| D007294 | Inositol |
| ID | Term |
|---|---|
| D013402 | Sugar Alcohols |
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
| D002241 | Carbohydrates |
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| Myo-inositol | Dietary Supplement | Supplementation of myo-inositol (4 g/die), starting at least 4 weeks before rFSH administration |
|
| 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) |