Role of Myo-inositol and D-chiro-inositol on Oocyte Quality

Phase 4

Completed

• Conditions: Infertility
• Interventions: Dietary Supplement: Myo-inositol; Dietary Supplement: D-chito-Inositol

• Registration Number: NCT01338844
• Lead Sponsor: AGUNCO Obstetrics and Gynecology Centre

Brief Summary

Controlled ovarian hyperstimulation with gonadotropins is an integral part of the various stimulation protocols for patients undergoing in-vitro fertilization (IVF) and other Assisted Reproductive Technologies (ART) such as intracytoplasmic sperm injection (ICSI).

The hormonal control of multiple follicular growth and maturation is a critical part of ART procedures since it maximizes the yield of embryos to be transferred, thus increasing the cumulative pregnancy rate.

Recent studies have shown the efficacy of myo-inositol (MI) supplementation as a simple and highly effective treatment in order to improve oocyte quality in patients undergoing IVF. Indeed, it was previously shown that MI follicular fluid (FF) concentration is a reliable predictor of oocyte quality. High MI concentration in the FF directly correlates with high oocyte and embryo quality.

Another stereoisomer of Inositol was successfully used into clinical practice D-chiro-inositol (DCI). In particular, DCI supplementation was used to restore ovulation in hyperglycemic PCOS patients.

In the present study we aim to compare MI versus DCI supplementation on oocyte quality of women undergoing IVF-ET

Detailed Description

Not available

Study Timeline

• Status Verified: 2011-04
• Study First Submitted: 2011-04-14
• Study First Submitted QC: 2011-04-19
• Study First Posted: 2011-04-20
• Last Update Submitted: 2011-05-31
• Last Update Posted: 2011-06-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: Not specified

Inclusion Criteria

• women undergoing IVF treatments
• Body mass index <28
• FSH <10IU/L
• Normal uterine cavity, anatomy and functions

Exclusion Criteria

• PCOS
• Stage III or IV endometriosis
• Premature ovarian failure
• Poor responder

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Myo-inositol	Myo-inositol	Patients will receive 4g/day of myo-inositol
D-Chiro-inositol	D-chito-Inositol	Patients will receive 1.2g/day of D-chiro-inositol

Primary Outcome Measures

Name	Time	Method
number of morphologically mature oocytes
number of grade 1 embryos
Total international units (IU) of recombinant FSH administrated

Trial Locations

Locations (3)

San Raffaele Hospital; 🇮🇹 Milan, Italy

Research Center for Reproductive Medicine Villa Mafalda; 🇮🇹 Roma, Italy

Agunco; 🇮🇹 Rome, Italy