Inositols and FSH in IVF

Use of Inositols Within IVF Protocols to Reduce Gonadotropin Administration

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 Overview

• Status: Completed
• Conditions: Amount of FSH Units During Ovarian Stimulation Protocols
• Intervention / Treatment: Dietary supplement: Myo-inositol; Dietary supplement: D-chiro-inositol

• Study Type: Interventional
• Enrollment (Actual): 300
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Italy
  • Roma, Italy, 00198
    • Clinica Alma Res

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 36 years (Adult)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

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

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)

Collaborators and Investigators

• Sponsor: Lo.Li.Pharma s.r.l

Study record dates

Study Major Dates

• Study Start (Actual): November 2, 2020
• Primary Completion (Actual): November 30, 2023
• Study Completion (Actual): February 27, 2024

Study Registration Dates

• First Submitted: September 30, 2020
• First Submitted That Met QC Criteria: October 5, 2020
• First Posted (Actual): October 6, 2020

Study Record Updates

• Last Update Posted (Actual): July 9, 2025
• Last Update Submitted That Met QC Criteria: July 7, 2025
• Last Verified: July 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Micronutrients; Vitamin B Complex; Vitamins; Inositol
• Other Study ID Numbers: MI_DCI_FSH

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No