Role of Myo-inositol and D-chiro-inositol on Oocyte Quality
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01338844|
Recruitment Status : Completed
First Posted : April 20, 2011
Last Update Posted : June 1, 2011
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
|Condition or disease||Intervention/treatment||Phase|
|Infertility||Dietary Supplement: Myo-inositol Dietary Supplement: D-chito-Inositol||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|Official 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.|
Patients will receive 1.2g/day of D-chiro-inositol
Dietary Supplement: D-chito-Inositol
Active Comparator: Myo-inositol
Patients will receive 4g/day of myo-inositol
Dietary Supplement: Myo-inositol
- number of morphologically mature oocytes
- Total international units (IU) of recombinant FSH administrated
- number of grade 1 embryos
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01338844
|San Raffaele Hospital|
|Research Center for Reproductive Medicine Villa Mafalda|
|Principal Investigator:||Gianfranco Carlomagno, Ph.D.||AGUNCO Obstetrics and Gynecology Centre|
|Principal Investigator:||Vittorio Unfer, M.D.||AGUNCO Obstetrics and Gynecology Centre|
|Principal Investigator:||Franco Lisi, M.D.||Research Center for Reproductive Medicine|
|Principal Investigator:||Enrico Papaleo, M.D.||San Raffaele Hospital|
|Principal Investigator:||Scott Roseff, MD||The Palm Beach Center for Reproductive Medicine|