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NCT05449171 Clinical Trial

High Molecular Weight Hyaluronic Acid, α-lipoic Acid, Magnesium, Vitamin B6 and Vitamin D, in the Prevention of Spontaneous Abortion

Abortion, Spontaneous Clinical Trial

Official title:
Efficacy of the Association of Hyaluronic Acid With High Molecular Weight, α-lipoic Acid (ALA), Magnesium, Vitamin B6 and Vitamin D, in the Prevention of Spontaneous Abortion in Patients at Risk

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT05449171
Other study ID # HA-PREV_22
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date September 1, 2022
Est. completion date January 31, 2024

Study information
Verified date February 2024
Source Lo.Li.Pharma s.r.l
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The study aims to verify if the association of high molecular weight hyaluronic acid, α-lipoic acid (ALA), magnesium, vitamin B6 and vitamin D, reduces the risk of miscarriage in patients at risk.

Recruitment information / eligibility
Status Completed
Enrollment 100
Est. completion date January 31, 2024
Est. primary completion date September 1, 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 18 Years to 45 Years
Eligibility Inclusion Criteria: - two or more previous spontaneous first trimester abortions without apparent risk factors (idiopathic polyabortion) - Endocrinopathies - Autoimmune diseases - Thrombophililic or coagulation diseases Exclusion Criteria: - Multiple pregnancies - Presence of genetic abnormalities of one or both partners leading to increased risk of fetal aneuploidies - Presence of Mullerian abnormalities in the uterus - Symptoms present at recruitment such as pelvic pain or metrorrhagia

Study Design

Related Conditions & MeSH terms

Intervention

Other:
• high molecular weight hyaluronic acid, a-lipoic acid (ALA), magnesium, vitamin B6 and vitamin D
Patients will take an association of high molecular weight hyaluronic acid, a-lipoic acid (ALA), magnesium, vitamin B6 and vitamin D, from the first visit at the experimental center (within the 12th week of gestation) for 3 months.

Locations
Country Name City State
Italy Dipartimento di Neuroscienze e Scienze riproduttive ed odontostomatologiche Napoli

Sponsors (1)
Lead Sponsor Collaborator
Lo.Li.Pharma s.r.l

Country where clinical trial is conducted

Italy, 

Outcome
Type Measure Description Time frame Safety issue
Primary Incidence of metrorrhagia and/or pelvic pain in the first trimester of gestation. 3 months
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