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

Lo.Li.Pharma

Status: Completed

Conditions: Abortion, Spontaneous

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

Study type: Interventional

Funder types: Industry

Identifiers

NCT05449171

HA-PREV_22

Details and patient eligibility

About

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.

Enrollment: 100 patients

Sex: Female

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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100 participants in 2 patient groups

Control group

No Intervention group

Treatment group

Experimental group

Treatment:

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