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

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

An open clinical trial

Study Overview

• Status: Unknown
• Conditions: Polycystic Ovary Syndrome
• Intervention / Treatment: Drug: Folic Acid

Detailed Description

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

• Study Type: Interventional
• Enrollment (Anticipated): 90
• Phase: Phase 2; Phase 1

Contacts and Locations

• Study Contact: Name: Mohammed Hassan Alnazeer; Phone Number: 00249912907268; Email: mhmd_nazir83@yahoo.com

Study Locations

• Sudan
  • Khartoum, Sudan, 11111
    • Recruiting
    • Saad Abul ella fertility Centre
    • Contact: Mohammed ibrahim Awad; Phone Number: 00249900904060; Email: awad22mohd@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 38 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Treatment group; 45 PCOS patients will receive 5 mg folic acid	Drug: Folic Acid; Tablet 5 mg
No Intervention: control group; 45 PCOS patients will receive no folic acid

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: University of Khartoum
• Collaborators: Awad, Mohamed Ibrahim, M.D.; Duria abdulwahab Elrrayes
• Investigators: Study Chair: Mohammed Hassan Alnazeer, University of Khartoum

Study record dates

Study Major Dates

• Study Start (Anticipated): September 1, 2017
• Primary Completion (Anticipated): September 1, 2018
• Study Completion (Anticipated): September 1, 2019

Study Registration Dates

• First Submitted: August 24, 2017
• First Submitted That Met QC Criteria: August 28, 2017
• First Posted (Actual): August 31, 2017

Study Record Updates

• Last Update Posted (Actual): August 31, 2017
• Last Update Submitted That Met QC Criteria: August 28, 2017
• Last Verified: August 1, 2017

More Information

Terms related to this study

• Keywords: Insulin resistance; Infertility; PCOS; Folic acid
• Additional Relevant MeSH Terms: Pathologic Processes; Neoplasms; Endocrine System Diseases; Disease; Ovarian Cysts; Cysts; Ovarian Diseases; Adnexal Diseases; Gonadal Disorders; Polycystic Ovary Syndrome; Syndrome; Physiological Effects of Drugs; Micronutrients; Vitamins; Vitamin B Complex; Hematinics; Folic Acid
• Other Study ID Numbers: Folic acid in PCOS

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided
• IPD Plan Description: still undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No