Inositols and FSH in IVF

Lo.Li.Pharma

Status: Unknown

Conditions: Amount of FSH Units During Ovarian Stimulation Protocols

Treatments: Dietary Supplement: D-chiro-inositol; Dietary Supplement: Myo-inositol

Study type: Interventional

Funder types: Industry

Identifiers

NCT04576546

MI_DCI_FSH

Details and patient eligibility

About

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.

Enrollment: 30 estimated patients

Sex: Female

Ages: 18 to 40 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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30 participants in 2 patient groups

comparator group

Active Comparator group

Description:

myo-inositol treatment

Treatment:

Dietary Supplement: Myo-inositol

study group

Experimental group

Description:

D-chiro-inositol treatment

Treatment:

Dietary Supplement: D-chiro-inositol