The Effects of Folic Acid on Sudanese Women With Polycystic Ovary Syndrome

Study Overview
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Brief Summary
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An open clinical trial

Detailed Description
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The patients with PCOS will be recruited to receive folic acid (45 patients) and equal number will receive no folic acid

Official Title
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The Clinical and Biochemical Effects of Folic Acid on Sudanese Women With Polycystic Ovary Syndrome (PCOS)

Conditions
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Polycystic Ovary Syndrome

Intervention / Treatment
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* Drug: Folic Acid


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients who will visit this centre suffering from PCOS-related subfertility will be invited to be enrolled to this study if met the Rotterdam criteria for the diagnosis of PCOS Exclusion Criteria: The patients whom will be excluded from the study are those comorbid with hyperprolactinemia, congenital adrenal hyperplasia, diabetes mellitus, significant cardiovascular problems, thyroid dysfunctions, unresolved medical conditions, or using medications suspected to affect reproductive or metabolic functions within two months of the study entry.

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 40 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
Interventional Model Description: Open trial
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment group<br>45 PCOS patients will receive 5 mg folic acid | Drug: Folic Acid<br>* Tablet 5 mg<br>|
| No Intervention: control group<br>45 PCOS patients will receive no folic acid | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| pregnancy rates | Pregnancy rates will be compared in the treatment group and control group | 3 months | 
| Ovulatory pattern improvements | Ovulatory pattern will be assessed based on the history of the PCOS patients, the patients whom were having baseline oligomenorrhea or amenorrhea will be re-assessed for resuming regular cycles defined as periods lasting 22 - 35 days. this pattern improvement will be compared in the treatment group and control group using questionnaire | 3 months | 
| Clinical signs of hyperandrogenemia | Hirsutism will be used as a sign of hyperandrogenemia, Patients will be provided with modified Ferriman -Gallwey (mFG) images to self-rate hair growth in each of the 9 body areas (upper lip, chin, chest, upper and lower back, upper and lower abdomen, thighs, and upper arms). For each site, a score on a scale of 0 to 4 was recorded. A total score of 8 or greater is defined as clinical evidence of hirsutism; scores from 8 to 15 are considered mild hirsutism; scores from16 to 25 are considered moderate; and scores from 26 to 36 are considered severe hirsutism. The baseline and after 3 months hirsutism compared in the treatment group and control group | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Plasma level of testosterone | Plasma level of testosterone will be compared in the treatment group and control group | 3 months | 
| Plasma level of insulin | Plasma level of insulin will be compared in the treatment group and control group | 3 months | 
| Plasma level of follicle-stimulating hormone (FSH) | Plasma level of follicle-stimulating hormone will be compared in the treatment group and control group | 3 months | 
| Plasma level of luteinizing hormone (LH) | Plasma level of luteinizing hormone will be compared in the treatment group and control group | 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Folic acid, PCOS, Insulin resistance, Infertility