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

Phase 1

• Conditions: Polycystic Ovary Syndrome
• Interventions: Drug: Folic Acid

• Registration Number: NCT03268733
• Lead Sponsor: University of Khartoum

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

Study Timeline

• Status Verified: 2017-08
• Study First Submitted: 2017-08-24
• Study First Submitted QC: 2017-08-28
• Last Update Submitted: 2017-08-28
• Study First Posted: 2017-08-31
• Last Update Posted: 2017-08-31
• Study Start: 2017-09-01
• Primary Completion: 2018-09-01
• Study Completion: 2019-09-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 90

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

Read More

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.

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Treatment group	Folic Acid	45 PCOS patients will receive 5 mg folic acid

Primary Outcome Measures

Name	Time	Method
Ovulatory pattern improvements	3 months	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	3 months	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
pregnancy rates	3 months	Pregnancy rates will be compared in the treatment group and control group

Secondary Outcome Measures

Name	Time	Method
Plasma level of insulin	3 months	Plasma level of insulin will be compared in the treatment group and control group
Plasma level of testosterone	3 months	Plasma level of testosterone will be compared in the treatment group and control group
Plasma level of follicle-stimulating hormone (FSH)	3 months	Plasma level of follicle-stimulating hormone will be compared in the treatment group and control group
Plasma level of luteinizing hormone (LH)	3 months	Plasma level of luteinizing hormone will be compared in the treatment group and control group

Trial Locations

Locations (1)

Saad Abul ella fertility Centre; 🇸🇩 Khartoum, Sudan