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

Women Infertility Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03055442
• Other study ID #: MI/DCI_FF
• Status: Completed
• Phase: N/A
• First received: February 8, 2017
• Last updated: February 13, 2017
• Start date: October 2016
• Est. completion date: December 2016

Study information

• Verified date: February 2017
• Source: Lo.Li.Pharma s.r.l
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 34
• Est. completion date: December 2016
• Est. primary completion date: November 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 28 Years

Eligibility

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.

Related Conditions & MeSH terms

• Infertility
• Women Infertility

Intervention

Other:
• Dosage of myo-inositol
Quantitative analysis of myo-inositol was performed by gas chromatography-mass spectrometry (GC-MS)
• Dosage of D-chiro-inositol
Quantitative analysis of D-chiro-inositol was performed by gas chromatography-mass spectrometry (GC-MS)

Locations

Country	Name	City	State
Greece	Iakentro Advanced Medical Centre, IVF Unit	Thessaloniki

Sponsors (1)

Lead Sponsor	Collaborator
Lo.Li.Pharma s.r.l

Country where clinical trial is conducted

Greece, 

References & Publications (3)

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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