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

Primary Purpose

Polycystic Ovary Syndrome

Status
Unknown status
Phase
Phase 1
Locations
Sudan
Study Type
Interventional
Intervention
Folic Acid
Sponsored by
University of Khartoum
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Polycystic Ovary Syndrome focused on measuring Folic acid, PCOS, Insulin resistance, Infertility

Eligibility Criteria

20 Years - 40 Years (Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

  • Saad Abul ella fertility CentreRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Treatment group

control group

Arm Description

45 PCOS patients will receive 5 mg folic acid

45 PCOS patients will receive no folic acid

Outcomes

Primary Outcome Measures

pregnancy rates
Pregnancy rates will be compared in the treatment group and control group
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
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

Secondary Outcome Measures

Plasma level of testosterone
Plasma level of testosterone will be compared in the treatment group and control group
Plasma level of insulin
Plasma level of insulin will be compared in the treatment group and control group
Plasma level of follicle-stimulating hormone (FSH)
Plasma level of follicle-stimulating hormone will be compared in the treatment group and control group
Plasma level of luteinizing hormone (LH)
Plasma level of luteinizing hormone will be compared in the treatment group and control group

Full Information

First Posted
August 24, 2017
Last Updated
August 28, 2017
Sponsor
University of Khartoum
Collaborators
Awad, Mohamed Ibrahim, M.D., Duria abdulwahab Elrrayes
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1. Study Identification

Unique Protocol Identification Number
NCT03268733
Brief Title
The Effects of Folic Acid on Sudanese Women With Polycystic Ovary Syndrome
Acronym
FolicacidPCOS
Official Title
The Clinical and Biochemical Effects of Folic Acid on Sudanese Women With Polycystic Ovary Syndrome (PCOS)
Study Type
Interventional

2. Study Status

Record Verification Date
August 2017
Overall Recruitment Status
Unknown status
Study Start Date
September 1, 2017 (Anticipated)
Primary Completion Date
September 1, 2018 (Anticipated)
Study Completion Date
September 1, 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Khartoum
Collaborators
Awad, Mohamed Ibrahim, M.D., Duria abdulwahab Elrrayes

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Polycystic Ovary Syndrome
Keywords
Folic acid, PCOS, Insulin resistance, Infertility

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Model Description
Open trial
Masking
None (Open Label)
Allocation
Randomized
Enrollment
90 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Treatment group
Arm Type
Experimental
Arm Description
45 PCOS patients will receive 5 mg folic acid
Arm Title
control group
Arm Type
No Intervention
Arm Description
45 PCOS patients will receive no folic acid
Intervention Type
Drug
Intervention Name(s)
Folic Acid
Intervention Description
Tablet 5 mg
Primary Outcome Measure Information:
Title
pregnancy rates
Description
Pregnancy rates will be compared in the treatment group and control group
Time Frame
3 months
Title
Ovulatory pattern improvements
Description
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
Time Frame
3 months
Title
Clinical signs of hyperandrogenemia
Description
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
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Plasma level of testosterone
Description
Plasma level of testosterone will be compared in the treatment group and control group
Time Frame
3 months
Title
Plasma level of insulin
Description
Plasma level of insulin will be compared in the treatment group and control group
Time Frame
3 months
Title
Plasma level of follicle-stimulating hormone (FSH)
Description
Plasma level of follicle-stimulating hormone will be compared in the treatment group and control group
Time Frame
3 months
Title
Plasma level of luteinizing hormone (LH)
Description
Plasma level of luteinizing hormone will be compared in the treatment group and control group
Time Frame
3 months
Other Pre-specified Outcome Measures:
Title
Lipid profile
Description
Lipid profile will be compared in the treatment group and control group
Time Frame
3 months
Title
Plasma level of random glucose
Description
Plasma level of random glucose will be compared in the treatment group and control group
Time Frame
3 months
Title
Plasma level of folate
Description
Plasma level of folate will be compared in the treatment group and control group
Time Frame
3 months
Title
Plasma level of homocysteine (Hcy)
Description
Plasma level of homocysteine (Hcy) will be compared in the treatment group and control group
Time Frame
3 months
Title
Plasma level of hemoglobin (Hb)
Description
Plasma level of hemoglobin (Hb) will be compared in the treatment group and control group
Time Frame
3 months
Title
Plasma level of C-reactive protein (CRP)
Description
Plasma level of C-reactive protein (CRP) will be compared in the treatment group and control group
Time Frame
3 months

10. Eligibility

Sex
Female
Gender Based
Yes
Gender Eligibility Description
female patients suffering from PCOS-related subfertility
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Mohammed Hassan Alnazeer
Phone
00249912907268
Email
mhmd_nazir83@yahoo.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mohammed Hassan Alnazeer
Organizational Affiliation
University of Khartoum
Official's Role
Study Chair
Facility Information:
Facility Name
Saad Abul ella fertility Centre
City
Khartoum
ZIP/Postal Code
11111
Country
Sudan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mohammed ibrahim Awad
Phone
00249900904060
Email
awad22mohd@gmail.com

12. IPD Sharing Statement

Plan to Share IPD
Undecided
IPD Sharing Plan Description
still undecided

Learn more about this trial

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

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