Clinical Trials Logo
  1. Home
  2. Abortion, Spontaneous
  3. NCT05449171
  4. Details
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
See also
  Status Clinical Trial Phase
Active, not recruiting NCT05896657 - Modulation of Reproductive Microbiota by Ligilactobacillus Salivarius CECT5713 N/A
Active, not recruiting NCT03736681 - Effect of Paracervical Block Volume on Pain Control for Dilation and Curettage Phase 1
Completed NCT03636451 - Effect of Paracervical Block Volume on Pain Control for Dilation and Curettage.o Phase 3
Completed NCT01335802 - Relation Between Subclinical Hypothyroidism and Outcome of Pregnancy
Active, not recruiting NCT05516810 - The Accuracy of Ultrasound Diagnosis of Hydatidiform Moles
Completed NCT04446572 - Application of Lactobacillus Salivarius CECT5713 in Infertility of Unknown Origin Phase 2
Completed NCT01033903 - Optimal Treatment of Miscarriage N/A
Withdrawn NCT02328742 - Development of a Bioabsorbable Medical Device for the Prevention of Postoperative Intra-uterine Adhesions. N/A
Completed NCT01762098 - Chronic Endometritis in Patients With Recurrent Miscarriages or Repeated Implantation Failures in In-vitro Fertilization N/A
Active, not recruiting NCT04360564 - RPL: Interval to Live Birth and Adverse Perinatal Outcomes
Completed NCT04791020 - Topic Cervical Anesthesia Plus Paracervical Blockade for Pain Control During Endouterine Manual Aspiration N/A
Recruiting NCT03220750 - University Hospital Advanced Age Pregnant Cohort N/A
Completed NCT01904669 - Internet-based Study of Fertility and Early Pregnancy (PEEPS) N/A
Not yet recruiting NCT00491270 - Bacterial Vaginosis Screening and Treatment to Reduce Infective Complications, Abortion and Preterm Delivery Phase 3
Active, not recruiting NCT02434900 - Vitamin D and Angiogenic Markers in Odense Child Cohort 1 N/A
Completed NCT03703401 - The Role of Hydrosalpinx in Recurrent Miscarriage
Completed NCT01788540 - Intralipid for Recurrent Miscarriage Phase 4
Recruiting NCT02633475 - Interleukin-10 Promoter-1082A/G Polymorphism and Idiopathic Recurrent Miscarriage Risk N/A
Completed NCT02761772 - Early Pregnancy Cohort and Preimplantation Factor
Not yet recruiting NCT00256009 - Treatment of Late Abortion: Evacuatio Uteri or Conservative Treatment Phase 4