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Completed

NCT Number: NCT03055442

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

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.

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Key information

Conditions

Women Infertility

Age range

18 year–28 year

Sex eligibility

Female

Study type

Observational

Primary location

Iakentro Advanced Medical Centre, IVF Unit

Thessaloniki, Greece

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Dosage of myo-inositol

Other

Quantitative analysis of myo-inositol was performed by gas chromatography-mass spectrometry (GC-MS)

Dosage of D-chiro-inositol

Other

Quantitative analysis of D-chiro-inositol was performed by gas chromatography-mass spectrometry (GC-MS)

Primary outcomes

  1. 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.

  2. 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.

Sponsors and collaborators

Lead sponsor

Lo.Li.Pharma s.r.l

Industry

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2016
Study completion
2016
First posted
Feb 16, 2017
Registry last updated
Feb 16, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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