Folic Acid vs 5-methyltetrahydrofolate (5MTHF) in Recurrent Abortion

Study Overview
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Brief Summary
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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.

Official Title
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Comparison of the Effect of Folic Acid and 5-methyltetrahydrofolate (5MTHF) on Serum Folate and Homocysteine Levels, and Abortion Rates in Women Suffering From Recurrent Abortion

Conditions
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Recurrent Abortion

Intervention / Treatment
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* Dietary Supplement: 5-methyltetrahydrofolate
* Dietary Supplement: folic Acid


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 5-methyltetrahydrofolate<br>1 mg 5-methyltetrahydrofolate per day | Dietary Supplement: 5-methyltetrahydrofolate<br> <br> |
| Active Comparator: folic acid<br>1 mg Folic acid per day | Dietary Supplement: folic Acid<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ongoing pregnancy on the 20th week of gestational age |  | 20th week of gestational age | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | 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 |