Recurrent Abortion
Conditions
Brief summary
Recent data indicates that 5 methyltetrahydrofolate (5MTHF) can reduce serum homocystein level more efficiently than folic acid. On the other hand, folic acid is currently an important part of treatment in idiopathic recurrent abortion. There is no study comparing the effectiveness of these supplements in the treatment of recurrent abortion. The aim of this study is to compare the efficiency of these two agents in the treatment of recurrent abortion. In this study, patients with idiopathic recurrent abortion, referring to Avicenna clinic will be randomly allocated into two groups of those taking either folic acid (5 mg) or 5 MTHF (5mg) from 8 weeks prior to conception until the 20th week of pregnancy. The serum level of folate, homocystein, and ongoing pregnancy will be analysed and compared in the two groups.
Interventions
DIETARY_SUPPLEMENT5-methyltetrahydrofolate
DIETARY_SUPPLEMENTfolic Acid
Sponsors
National Nutrition and Food Technology Institute
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 50 Years
Healthy volunteers
No
Inclusion criteria
* Willing to participate in the study and filling out the informed consent form, * History of 3 or more idiopathic abortion, * the last abortion should be more than 6 months ago, * no history of consumption of folate supplements or high folate containing foods during last 6 months, * All previous abortions should be idiopathic without any anatomic, cytologic, hormonal, septic pathologic finding, * no special diets
Exclusion criteria
* elective or induced abortion, molar or ectopic pregnancies, * presence of any malignancy, chromosomal abnormality, uterine abnormality, Thyroid, kidney, or liver dysfunction, Glucose intolerance, seizure, * Alcohol or drug abuse, * Taking any drug affecting homocystein metabolism, * not following the study protocol.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| ongoing pregnancy on the 20th week of gestational age | 20th week of gestational age |
Secondary
| Measure | Time frame |
|---|---|
| serum concentration of folate | at the weeks 0 and 8 of the study, and weeks of 4, 8, 12, and 20th gestational age |
| Serum concentration of Homocystein | at the weeks 0 and 8 of the study, and weeks of 4, 8, 12, and 20th gestational age |
Outcome results
None listed