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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03055442
Recruitment Status : Completed
First Posted : February 16, 2017
Last Update Posted : February 16, 2017
Sponsor:
Information provided by (Responsible Party):
Lo.Li.Pharma s.r.l

Brief Summary:
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.

Condition or disease Intervention/treatment
Women Infertility Other: Dosage of myo-inositol Other: Dosage of D-chiro-inositol

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Study Type : Observational
Actual Enrollment : 34 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official 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
Study Start Date : October 2016
Actual Primary Completion Date : November 2016
Actual Study Completion Date : December 2016

Resource links provided by the National Library of Medicine

Drug Information available for: Inositol

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)




Primary Outcome Measures :
  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.




Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 28 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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.

Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03055442


Locations
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Greece
Iakentro Advanced Medical Centre, IVF Unit
Thessaloniki, Greece
Sponsors and Collaborators
Lo.Li.Pharma s.r.l
Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Lo.Li.Pharma s.r.l
ClinicalTrials.gov Identifier: NCT03055442    
Other Study ID Numbers: MI/DCI_FF
First Posted: February 16, 2017    Key Record Dates
Last Update Posted: February 16, 2017
Last Verified: February 2017

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Infertility
Inositol
Vitamin B Complex
Vitamins
Micronutrients
Nutrients
Growth Substances
Physiological Effects of Drugs