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

Completed

• Conditions: Women Infertility
• Interventions: Other: Dosage of myo-inositol; Other: Dosage of D-chiro-inositol

• Registration Number: NCT03055442
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-10
• Primary Completion: 2016-11
• Study Completion: 2016-12
• Status Verified: 2017-02
• Study First Submitted: 2017-02-08
• Study First Submitted QC: 2017-02-13
• Last Update Submitted: 2017-02-13
• Study First Posted: 2017-02-16
• Last Update Posted: 2017-02-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 34

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Follicular Fluids	Dosage of D-chiro-inositol	Follicular fluids obtained by 8 oocyte donors
Follicular Fluids	Dosage of myo-inositol	Follicular fluids obtained by 8 oocyte donors

Primary Outcome Measures

Name	Time	Method
Myo-inositol concentration (µmol/l) in follicular fluid	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.
D-chiro-inositol concentration (µmol/l) in follicular fluid	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.

Trial Locations

Locations (1)

Iakentro Advanced Medical Centre, IVF Unit; 🇬🇷 Thessaloniki, Greece