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

NCT ID: NCT03055442

Last Updated: 2017-02-16

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

Total Enrollment

34 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-10-31

Study Completion Date

2016-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Women Infertility

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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Follicular Fluids

Follicular fluids obtained by 8 oocyte donors

Dosage of myo-inositol

Intervention Type OTHER

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

Dosage of D-chiro-inositol

Intervention Type OTHER

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

Interventions

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Dosage of myo-inositol

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

Intervention Type OTHER

Dosage of D-chiro-inositol

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

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

28 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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Iakentro Advanced Medical Centre, IVF Unit

Thessaloniki, , Greece

Site Status

Countries

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Greece

References

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Chiu TT, Rogers MS, Law EL, Briton-Jones CM, Cheung LP, Haines CJ. Follicular fluid and serum concentrations of myo-inositol in patients undergoing IVF: relationship with oocyte quality. Hum Reprod. 2002 Jun;17(6):1591-6. doi: 10.1093/humrep/17.6.1591.

Reference Type BACKGROUND
PMID: 12042283 (View on PubMed)

Carlomagno G, Unfer V, Roseff S. The D-chiro-inositol paradox in the ovary. Fertil Steril. 2011 Jun 30;95(8):2515-6. doi: 10.1016/j.fertnstert.2011.05.027. Epub 2011 Jun 8.

Reference Type BACKGROUND
PMID: 21641593 (View on PubMed)

Gardner DK, Lane M, Stevens J, Schlenker T, Schoolcraft WB. Blastocyst score affects implantation and pregnancy outcome: towards a single blastocyst transfer. Fertil Steril. 2000 Jun;73(6):1155-8. doi: 10.1016/s0015-0282(00)00518-5.

Reference Type BACKGROUND
PMID: 10856474 (View on PubMed)

Ravanos K, Monastra G, Pavlidou T, Goudakou M, Prapas N. Can high levels of D-chiro-inositol in follicular fluid exert detrimental effects on blastocyst quality? Eur Rev Med Pharmacol Sci. 2017 Dec;21(23):5491-5498. doi: 10.26355/eurrev_201712_13940.

Reference Type DERIVED
PMID: 29243796 (View on PubMed)

Other Identifiers

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MI/DCI_FF

Identifier Type: -

Identifier Source: org_study_id

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