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

NCT03055442 | Completed

• 1 other identifier: MI/DCI_FF
• Study Type: observational
• Target: 34
• Locations: 1 country
• Sites: 1

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.

Conditions

Women Infertility

Outcome Measures

Primary Outcomes (2)

• Myo-inositol concentration (µmol/l) in follicular fluid

  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

  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

Study Arms (1)

Follicular Fluids

Follicular fluids obtained by 8 oocyte donors

Other: Dosage of myo-inositol; Other: Dosage of D-chiro-inositol

Interventions

Dosage of myo-inositol OTHER

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

Follicular Fluids

Dosage of D-chiro-inositol OTHER

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

Follicular Fluids

Eligibility Criteria

• Age: 18 Years - 28 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• 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.

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Lo.Li.Pharma s.r.l: lead

Study Sites (1)

Iakentro Advanced Medical Centre, IVF Unit

Thessaloniki, Greece

Location

Related Publications (4)

• 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.

  PMID: 12042283 BACKGROUND

• 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.

  PMID: 21641593 BACKGROUND

• 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.

  PMID: 10856474 BACKGROUND

• 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.

  PMID: 29243796 DERIVED

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 8, 2017
• First Posted: February 16, 2017
• Study Start: October 1, 2016
• Primary Completion: November 1, 2016
• Study Completion: December 1, 2016
• Last Updated: February 16, 2017

Record last verified: 2017-02

Locations

GR (1)