Back to resultsHigh Molecular Weight Hyaluronic Acid, α-lipoic Acid, Magnesium, Vitamin B6 and Vitamin D, in the Prevention of Spontaneous Abortion
Primary Purpose
Abortion, Spontaneous
Status
Recruiting
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
high molecular weight hyaluronic acid, α-lipoic acid (ALA), magnesium, vitamin B6 and vitamin D
Sponsored by
About this trial
This is an interventional supportive care trial for Abortion, Spontaneous
Eligibility Criteria
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
Sites / Locations
- Dipartimento di Neuroscienze e Scienze riproduttive ed odontostomatologicheRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Experimental
Arm Label
Control group
Treatment group
Arm Description
Outcomes
Primary Outcome Measures
Incidence of metrorrhagia and/or pelvic pain in the first trimester of gestation.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05449171
Brief Title
High Molecular Weight Hyaluronic Acid, α-lipoic Acid, Magnesium, Vitamin B6 and Vitamin D, in the Prevention of Spontaneous Abortion
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
Study Type
Interventional
2. Study Status
Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 1, 2022 (Actual)
Primary Completion Date
September 2023 (Anticipated)
Study Completion Date
January 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Lo.Li.Pharma s.r.l
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Abortion, Spontaneous
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Control group
Arm Type
No Intervention
Arm Title
Treatment group
Arm Type
Experimental
Intervention Type
Other
Intervention Name(s)
high molecular weight hyaluronic acid, α-lipoic acid (ALA), magnesium, vitamin B6 and vitamin D
Intervention Description
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 Outcome Measure Information:
Title
Incidence of metrorrhagia and/or pelvic pain in the first trimester of gestation.
Time Frame
3 months
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Gabriele Saccone
Phone
+393394685179
Email
gabriele.saccone@unina.it
Facility Information:
Facility Name
Dipartimento di Neuroscienze e Scienze riproduttive ed odontostomatologiche
City
Napoli
ZIP/Postal Code
80131
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Gabriele Saccone
12. IPD Sharing Statement
Learn more about this trial
High Molecular Weight Hyaluronic Acid, α-lipoic Acid, Magnesium, Vitamin B6 and Vitamin D, in the Prevention of Spontaneous Abortion
We'll reach out to this number within 24 hrs