NCT Number: NCT01338844
Role of Myo-inositol and D-chiro-inositol on Oocyte Quality
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
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Notify MeKey information
Conditions
Age range
25 year–45 year
Sex eligibility
Female
Study type
Interventional
Phase
Phase 4
Primary location
San Raffaele Hospital, Milan, Italy
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
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
Treatment and study plan
D-chito-Inositol
Dietary SupplementPrimary outcomes
-
number of morphologically mature oocytes
-
Total international units (IU) of recombinant FSH administrated
-
number of grade 1 embryos
Sponsors and collaborators
Lead sponsor
AGUNCO Obstetrics and Gynecology Centre
Other
Collaborators
- Research Center for Reproductive Medicine Villa Mafalda
- San Raffaele University Hospital, Italy
Registry information
Official study title
A Prospective, Randomized, Double Blind, Study on the Clinical Efficacy Myo-inositol Versus D-chiro-inositol in Women Undergoing in Vitro Fertilization Embryo Transfer.
Important dates
- First posted
- Apr 20, 2011
- Registry last updated
- Jun 1, 2011
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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