Viewing Study NCT03023514



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Last Modification Date: 2024-10-26 @ 12:16 PM
Study NCT ID: NCT03023514
Status: COMPLETED
Last Update Posted: 2017-01-19
First Post: 2017-01-13

Brief Title: Lipoic Acid Supplementation in IVF
Sponsor: LoLiPharma srl
Organization: LoLiPharma srl

Study Overview

Official Title: None
Status: COMPLETED
Status Verified Date: 2017-01
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
Brief Summary: Alpha-Lipoic Acid ALA is a natural molecule that can make a significant contribution to the success of embryo implantation phase because it exerts directly or indirectly an immunomodulatory activity ALA has the ability to regenerate antioxidants molecules that facilitate embryo implantation and to stimulate the production of local mediators useful for implantation This study is a prospective clinical trial and aims to evaluate the reproductive outcomes of Italian couples following oocyte donation fresh cycles when receiving per os tablets of lipoic acid Indeed the control group had only the standard treatment vaginal progesterone whereas the study group in addition to that received ALA 300 mg 2 times per day by oral route from the day of donors oocyte pick up until the pregnancy test If the childbearing occurred treatment continued until the 8th week of pregnancy Primary outcome of the study is the implantation rate while the positive hCG rate the clinical pregnancy rate the miscarriage rate and the live-birth rate are secondary outcomes
Detailed Description: None

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: None
Is a FDA Regulated Device?: None
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None