Myo-inositol/D-chiro-inositol Ratio in Follicular Fluid

February 13, 2017 updated by: Lo.Li.Pharma s.r.l

Altered Myo-inositol/D-chiro-inositol Ratio in Follicular Fluid of Women Undergoing in Vitro Fertilization Has Detrimental Effects on Oocyte and Embryo Quality

Considering the importance assumed by follicular microenvironment for a proper oocyte development, this study is a prospective observational clinical trial which aims to evaluate whether the embryo blastocyst quality may be affected by different Myo-inositol (MI) and D-chiro-inositol (DCI) levels in the follicular fluid (FF) of the aspired oocytes. The study includes egg donors and egg receiving couples participating in the oocyte donation program. MI/DCI is calculated in FF and related with blastocyst grade.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

34

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Greece
      • Thessaloniki, Greece
        • Iakentro Advanced Medical Centre, IVF Unit

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years to 24 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

The study included 8 egg donors participating in the donation program of IAKENTRO not for the first time, and 11 recipient couples undergoing in vitro fertilization (ICSI).

Follicular fluid (FF) specimens were analysed.

Description

Inclusion Criteria:

  • clear follicular aspirate obtained during oocyte retrieval;
  • each specimen of follicular fluid containing only one oocyte.

Exclusion Criteria:

  • hyperglycaemic women;
  • PCOS women also if euglycaemic;
  • diabetic subjects having low concentrations of detectable MI in association with an anomalous MI transport.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Only
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Follicular Fluids
Follicular fluids obtained by 8 oocyte donors
Other: Dosage of myo-inositol
Quantitative analysis of myo-inositol was performed by gas chromatography-mass spectrometry (GC-MS)
Other: Dosage of D-chiro-inositol
Quantitative analysis of D-chiro-inositol was performed by gas chromatography-mass spectrometry (GC-MS)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Myo-inositol concentration (µmol/l) in follicular fluid
Time Frame: 5th day from pick up

After transvaginal aspiration of oocyte and follicular fluid and subsequent ICSI, at the day 5 the cultured embryos were graded according to Gardner's grading system for blastocysts. Then follicular fluids specimens were divided following the different scores given to the respective blastocysts, and their content in myo-inositol was quantified.

In each sample of follicular fluid myo-inositol levels were assessed. The quantitative analysis was performed by means of gas chromatography-mass spectrometry (GC-MS) and the values were expressed as µmol/l. This value was related to the respective blastocyst grade.
5th day from pick up
D-chiro-inositol concentration (µmol/l) in follicular fluid
Time Frame: 5th day from pick up

After transvaginal aspiration of oocyte and follicular fluid and subsequent ICSI, at the day 5 the cultured embryos were graded according to Gardner's grading system for blastocysts. Then follicular fluids specimens were divided following the different scores given to the respective blastocysts, and their content in D-chiro-inositol was quantified.

In each sample of follicular fluid D-chiro-inositol levels were assessed. The quantitative analysis was performed by means of gas chromatography-mass spectrometry (GC-MS) and the values were expressed as µmol/l. This value was related to the respective blastocyst grade.
5th day from pick up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Lo.Li.Pharma s.r.l

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2016

Primary Completion (Actual)

November 1, 2016

Study Completion (Actual)

December 1, 2016

Study Registration Dates

First Submitted

February 8, 2017

First Submitted That Met QC Criteria

February 13, 2017

First Posted (Actual)

February 16, 2017

Study Record Updates

Last Update Posted (Actual)

February 16, 2017

Last Update Submitted That Met QC Criteria

February 13, 2017

Last Verified

February 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MI/DCI_FF

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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