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

NCT ID: NCT03268733

Last Updated: 2017-08-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE1/PHASE2

Total Enrollment

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-09-01

Study Completion Date

2019-09-01

Brief Summary

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An open clinical trial

Detailed Description

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

Conditions

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Polycystic Ovary Syndrome

Keywords

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Folic acid PCOS Insulin resistance Infertility

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Open trial
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Treatment group

45 PCOS patients will receive 5 mg folic acid

Group Type EXPERIMENTAL

Folic Acid

Intervention Type DRUG

Tablet 5 mg

control group

45 PCOS patients will receive no folic acid

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Folic Acid

Tablet 5 mg

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

20 Years

Maximum Eligible Age

40 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Awad, Mohamed Ibrahim, M.D.

INDIV

Sponsor Role collaborator

Duria abdulwahab Elrrayes

UNKNOWN

Sponsor Role collaborator

University of Khartoum

OTHER

Sponsor Role lead

Responsible Party

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Mohammed Hassan Alnazeer

Clinical Pharmacist

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Mohammed Hassan Alnazeer

Role: STUDY_CHAIR

University of Khartoum

Locations

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Saad Abul ella fertility Centre

Khartoum, , Sudan

Site Status RECRUITING

Countries

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Sudan

Central Contacts

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Mohammed Hassan Alnazeer

Role: CONTACT

Phone: 00249912907268

Email: [email protected]

Facility Contacts

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Mohammed ibrahim Awad

Role: primary

Other Identifiers

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Folic acid in PCOS

Identifier Type: -

Identifier Source: org_study_id