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

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.

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Key information

Conditions

Abortion, Spontaneous Female Urogenital Diseases and Pregnancy Complications Pregnancy Complications Urogenital Diseases

Age range

18 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Dipartimento di Neuroscienze e Scienze riproduttive ed odontostomatologiche

Naples, 80131, Italy

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

high molecular weight hyaluronic acid, α-lipoic acid (ALA), magnesium, vitamin B6 and vitamin D

Other

Patients will take an association of high molecular weight hyaluronic acid, α-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.

Primary outcomes

Incidence of metrorrhagia and/or pelvic pain in the first trimester of gestation.

Time frame: 3 months

Sponsors and collaborators

Lead sponsor

Lo.Li.Pharma s.r.l

Industry

Registry information

Official study 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

Important dates

Study start: 2022
Primary completion: 2023
Study completion: 2024
First posted: Jul 8, 2022
Registry last updated: Feb 22, 2024

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.

Published trials that share one or more normalized conditions with this study.

Completed