NCT03268733

Brief Summary

An open clinical trial

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
90

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Sep 2017

Typical duration for phase_1

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 24, 2017

Completed
7 days until next milestone

First Posted

Study publicly available on registry

August 31, 2017

Completed
1 day until next milestone

Study Start

First participant enrolled

September 1, 2017

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2018

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2019

Completed
Last Updated

August 31, 2017

Status Verified

August 1, 2017

Enrollment Period

1 year

First QC Date

August 24, 2017

Last Update Submit

August 28, 2017

Conditions

Polycystic Ovary Syndrome

Keywords

Folic acidPCOSInsulin resistanceInfertility

Outcome Measures

Primary Outcomes (3)

  • 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 Outcomes (4)

  • Plasma level of testosterone

    3 months

  • Plasma level of insulin

    3 months

  • Plasma level of follicle-stimulating hormone (FSH)

    3 months

  • Plasma level of luteinizing hormone (LH)

    3 months

Other Outcomes (6)

  • Lipid profile

    3 months

  • Plasma level of random glucose

    3 months

  • Plasma level of folate

    3 months

  • +3 more other outcomes

Study Arms (2)

Treatment group

EXPERIMENTAL

45 PCOS patients will receive 5 mg folic acid

Drug: Folic Acid

control group

NO INTERVENTION

45 PCOS patients will receive no folic acid

Interventions

Folic AcidDRUG

Tablet 5 mg

Treatment group

Eligibility Criteria

Age20 Years - 40 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility Detailsfemale patients suffering from PCOS-related subfertility
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Saad Abul ella fertility Centre

Khartoum, 11111, Sudan

RECRUITING

MeSH Terms

Conditions

Polycystic Ovary SyndromeInsulin ResistanceInfertility

Interventions

Folic Acid

Condition Hierarchy (Ancestors)

Ovarian CystsCystsNeoplasmsOvarian DiseasesAdnexal DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital DiseasesGonadal DisordersEndocrine System DiseasesHyperinsulinismGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

PterinsPteridinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Study Officials

  • Mohammed Hassan Alnazeer

    University of Khartoum

    STUDY CHAIR

Central Study Contacts

Mohammed Hassan Alnazeer

CONTACT

00249912907268mhmd_nazir83@yahoo.com

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Open trial
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Pharmacist

Study Record Dates

First Submitted

August 24, 2017

First Posted

August 31, 2017

Study Start

September 1, 2017

Primary Completion

September 1, 2018

Study Completion

September 1, 2019

Last Updated

August 31, 2017

Record last verified: 2017-08

Locations

SU(1)