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

Polycystic Ovary Syndrome Clinical Trial

— FolicacidPCOS  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03268733
• Other study ID #: Folic acid in PCOS
• Status: Recruiting
• Phase: Phase 1/Phase 2
• First received: August 24, 2017
• Last updated: August 28, 2017
• Start date: September 1, 2017
• Est. completion date: September 1, 2019

Study information

• Verified date: August 2017
• Source: University of Khartoum
• Contact: Mohammed Hassan Alnazeer
• Phone: 00249912907268
• Email: mhmd_nazir83[@]yahoo.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

An open clinical trial

Description:

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 90
• Est. completion date: September 1, 2019
• Est. primary completion date: September 1, 2018
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 20 Years to 40 Years

Eligibility

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.

Related Conditions & MeSH terms

• Polycystic Ovary Syndrome
• Syndrome

Intervention

Drug:
• Folic Acid
Tablet 5 mg

Locations

Country	Name	City	State
Sudan	Saad Abul ella fertility Centre	Khartoum

Sponsors (3)

Lead Sponsor	Collaborator
University of Khartoum	Awad, Mohamed Ibrahim, M.D., Duria abdulwahab Elrrayes

Country where clinical trial is conducted

Sudan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Lipid profile	Lipid profile will be compared in the treatment group and control group	3 months
Other	Plasma level of random glucose	Plasma level of random glucose will be compared in the treatment group and control group	3 months
Other	Plasma level of folate	Plasma level of folate will be compared in the treatment group and control group	3 months
Other	Plasma level of homocysteine (Hcy)	Plasma level of homocysteine (Hcy) will be compared in the treatment group and control group	3 months
Other	Plasma level of hemoglobin (Hb)	Plasma level of hemoglobin (Hb) will be compared in the treatment group and control group	3 months
Other	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
Primary	pregnancy rates	Pregnancy rates will be compared in the treatment group and control group	3 months
Primary	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
Primary	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	Plasma level of testosterone	Plasma level of testosterone will be compared in the treatment group and control group	3 months
Secondary	Plasma level of insulin	Plasma level of insulin will be compared in the treatment group and control group	3 months
Secondary	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
Secondary	Plasma level of luteinizing hormone (LH)	Plasma level of luteinizing hormone will be compared in the treatment group and control group	3 months