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| Name | Class |
|---|---|
| Awad, Mohamed Ibrahim, M.D. | INDIV |
| Duria abdulwahab Elrrayes | UNKNOWN |
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An open clinical trial
The patients with PCOS will be recruited to receive folic acid (45 patients) and equal number will receive no folic acid
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment group | Experimental | 45 PCOS patients will receive 5 mg folic acid |
|
| control group | No Intervention | 45 PCOS patients will receive no folic acid |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Folic Acid | Drug | Tablet 5 mg |
|
| 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 |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Lipid profile | Lipid profile will be compared in the treatment group and control group | 3 months |
| Plasma level of random glucose | Plasma level of random glucose will be compared in the treatment group and control group |
Inclusion Criteria:
Exclusion Criteria:
female patients suffering from PCOS-related subfertility
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Mohammed Hassan Alnazeer | Contact | 00249912907268 | mhmd_nazir83@yahoo.com |
| Name | Affiliation | Role |
|---|---|---|
| Mohammed Hassan Alnazeer | University of Khartoum | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Saad Abul ella fertility Centre | Recruiting | Khartoum | 11111 | Sudan |
still undecided
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| ID | Term |
|---|---|
| D011085 | Polycystic Ovary Syndrome |
| D007333 | Insulin Resistance |
| D007246 | Infertility |
| ID | Term |
|---|---|
| D010048 | Ovarian Cysts |
| D003560 | Cysts |
| D009369 | Neoplasms |
| D010049 | Ovarian Diseases |
| D000291 |
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| ID | Term |
|---|---|
| D005492 | Folic Acid |
| ID | Term |
|---|---|
| D011622 | Pterins |
| D011621 | Pteridines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
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Open trial
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| 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 |
| 3 months |
| Plasma level of folate | Plasma level of folate will be compared in the treatment group and control group | 3 months |
| Plasma level of homocysteine (Hcy) | Plasma level of homocysteine (Hcy) will be compared in the treatment group and control group | 3 months |
| Plasma level of hemoglobin (Hb) | Plasma level of hemoglobin (Hb) will be compared in the treatment group and control group | 3 months |
| Plasma level of C-reactive protein (CRP) | Plasma level of C-reactive protein (CRP) will be compared in the treatment group and control group | 3 months |
| Adnexal Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
| D006058 | Gonadal Disorders |
| D004700 | Endocrine System Diseases |
| D006946 | Hyperinsulinism |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D006571 | Heterocyclic Compounds |