Inositols and FSH in IVF

NCT ID: NCT04576546

Last Updated: 2025-07-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

300 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-11-02

Study Completion Date

2024-02-27

Brief Summary

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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.

Detailed Description

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Conditions

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Amount of FSH Units During Ovarian Stimulation Protocols

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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comparator group

myo-inositol treatment

Group Type ACTIVE_COMPARATOR

Myo-inositol

Intervention Type DIETARY_SUPPLEMENT

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

study group

D-chiro-inositol treatment

Group Type EXPERIMENTAL

D-chiro-inositol

Intervention Type DIETARY_SUPPLEMENT

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

Interventions

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D-chiro-inositol

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

Intervention Type DIETARY_SUPPLEMENT

Myo-inositol

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

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Lo.Li.Pharma s.r.l

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Clinica Alma Res

Roma, , Italy

Site Status

Countries

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Italy

Other Identifiers

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MI_DCI_FSH

Identifier Type: -

Identifier Source: org_study_id

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