Polycystic Ovary Syndrome
Conditions
Keywords
Folic acid, PCOS, Insulin resistance, Infertility
Brief summary
An open clinical trial
Detailed description
The patients with PCOS will be recruited to receive folic acid (45 patients) and equal number will receive no folic acid
Interventions
DRUGFolic Acid
Tablet 5 mg
Sponsors
Awad, Mohamed Ibrahim, M.D.
Duria abdulwahab Elrrayes
University of Khartoum
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Open trial
Eligibility
Sex/Gender
FEMALE
Age
20 Years to 40 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| pregnancy rates | 3 months | Pregnancy rates will be compared in the treatment group and control group |
| Clinical signs of hyperandrogenemia | 3 months | 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 |
| Ovulatory pattern improvements | 3 months | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Plasma level of testosterone | 3 months | Plasma level of testosterone will be compared in the treatment group and control group |
| Plasma level of insulin | 3 months | Plasma level of insulin will be compared in the treatment group and control group |
| Plasma level of follicle-stimulating hormone (FSH) | 3 months | Plasma level of follicle-stimulating hormone will be compared in the treatment group and control group |
| Plasma level of luteinizing hormone (LH) | 3 months | Plasma level of luteinizing hormone will be compared in the treatment group and control group |
Other
| Measure | Time frame | Description |
|---|---|---|
| Plasma level of homocysteine (Hcy) | 3 months | Plasma level of homocysteine (Hcy) will be compared in the treatment group and control group |
| Plasma level of folate | 3 months | Plasma level of folate will be compared in the treatment group and control group |
| Plasma level of random glucose | 3 months | Plasma level of random glucose will be compared in the treatment group and control group |
| Plasma level of hemoglobin (Hb) | 3 months | Plasma level of hemoglobin (Hb) will be compared in the treatment group and control group |
| Plasma level of C-reactive protein (CRP) | 3 months | Plasma level of C-reactive protein (CRP) will be compared in the treatment group and control group |
| Lipid profile | 3 months | Lipid profile will be compared in the treatment group and control group |
Countries
Sudan
Contacts
Primary ContactMohammed Hassan Alnazeer
Outcome results
None listed