NCT04576546

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
300

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Nov 2020

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 30, 2020

Completed
6 days until next milestone

First Posted

Study publicly available on registry

October 6, 2020

Completed
27 days until next milestone

Study Start

First participant enrolled

November 2, 2020

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2023

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 27, 2024

Completed
Last Updated

July 9, 2025

Status Verified

July 1, 2025

Enrollment Period

3.1 years

First QC Date

September 30, 2020

Last Update Submit

July 7, 2025

Conditions

Amount of FSH Units During Ovarian Stimulation Protocols

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (5)

  • Total FSH (IU)

    1 day (single time-point at ovulation)

  • Duration of the stimulation

    1 day (single time-point at ovulation)

  • number of viable oocytes

    1 day (single time-point at oocyte pick-up)

  • oocyte quality

    1 day (single time-point at oocyte pick-up)

  • embryo quality

    1 day (single time-point at embryo transfer)

Study Arms (2)

comparator group

ACTIVE COMPARATOR

myo-inositol treatment

Dietary Supplement: Myo-inositol

study group

EXPERIMENTAL

D-chiro-inositol treatment

Dietary Supplement: D-chiro-inositol

Interventions

D-chiro-inositolDIETARY_SUPPLEMENT

Supplementation of D-chiro-inositol (1000 mg/die), starting at least 4 weeks before rFSH administration

study group
Myo-inositolDIETARY_SUPPLEMENT

Supplementation of myo-inositol (4 g/die), starting at least 4 weeks before rFSH administration

comparator group

Eligibility Criteria

Age18 Years - 40 Years
Sexfemale(Gender-based eligibility)
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Women undergoing IVF-ET procedure
  • HOMA-IR index \< 2.0
  • AMH in the range 1.0 - 2.0 ng/ml

You may not qualify if:

  • History of cancelled IVF cycles
  • BMI \< 20 kg/m2 or ≥ 30 kg/m2
  • Diagnosis of PCOS
  • Thyroid diseases
  • Presence of co-morbidities

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Clinica Alma Res

Roma, 00198, Italy

Location

MeSH Terms

Interventions

Inositol

Intervention Hierarchy (Ancestors)

Sugar AlcoholsAlcoholsOrganic ChemicalsCarbohydrates

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 30, 2020

First Posted

October 6, 2020

Study Start

November 2, 2020

Primary Completion

November 30, 2023

Study Completion

February 27, 2024

Last Updated

July 9, 2025

Record last verified: 2025-07

Data Sharing

IPD Sharing
Will not share

Locations

IT(1)