ClinicalTrials.gg
Sign In
Status unknownNCT03268733FolicacidPCOSUpdated Aug 31, 2017

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

A Phase 1/2 interventional study of Folic Acid in Polycystic Ovary Syndrome, sponsored by University of Khartoum. Status unknown at 1 site in Sudan. Open to female participants aged 20 Years to 40 Years. Per ClinicalTrials.gov, last updated 2017-08-31.

Sponsored by University of Khartoum · Phase 1/2, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Aug 2017), so the status shown — last known as Recruiting — may be out of date.
Phase
Phase 1/2
Study type
Interventional
Enrollment
90
Allocation
Randomized
Ages
20 Years to 40 Years
Sex
Female
01

Study summary

An open clinical trial

Read the detailed description

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

02

Conditions studied

  • Polycystic Ovary Syndrome

Keywords

  • Folic acid
  • PCOS
  • Insulin resistance
  • Infertility
03

In context

Polycystic Ovary Syndrome

956 studies on the registry are indexed under Polycystic Ovary Syndrome; 176 are open to participants now.

This study's planned enrollment of 90 is above the median of 70 across 697 interventional studies indexed under Polycystic Ovary Syndrome.

Browse Polycystic Ovary Syndrome studies →

Lead sponsor

University of Khartoum is the lead sponsor of 14 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years to 40 Years
Sexes eligible
Female
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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.
05

Study design

Phase
Phase 1 / Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
90 participants (estimated)

Study arms

  • Experimental
    Treatment group

    45 PCOS patients will receive 5 mg folic acid

    Drug: Folic Acid

  • No intervention
    control group

    45 PCOS patients will receive no folic acid

Interventions

06

What researchers measure

Primary outcomes

  1. pregnancy rates

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

    Time frame: 3 months

  2. 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

    Time frame: 3 months

  3. 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

    Time frame: 3 months

Secondary outcomes

  1. Plasma level of testosterone

    Plasma level of testosterone will be compared in the treatment group and control group

    Time frame: 3 months

  2. Plasma level of insulin

    Plasma level of insulin will be compared in the treatment group and control group

    Time frame: 3 months

  3. Plasma level of follicle-stimulating hormone (FSH)

    Plasma level of follicle-stimulating hormone will be compared in the treatment group and control group

    Time frame: 3 months

  4. Plasma level of luteinizing hormone (LH)

    Plasma level of luteinizing hormone will be compared in the treatment group and control group

    Time frame: 3 months

Other outcomes

  1. Lipid profile

    Lipid profile will be compared in the treatment group and control group

    Time frame: 3 months

  2. Plasma level of random glucose

    Plasma level of random glucose will be compared in the treatment group and control group

    Time frame: 3 months

  3. Plasma level of folate

    Plasma level of folate will be compared in the treatment group and control group

    Time frame: 3 months

  4. Plasma level of homocysteine (Hcy)

    Plasma level of homocysteine (Hcy) will be compared in the treatment group and control group

    Time frame: 3 months

  5. Plasma level of hemoglobin (Hb)

    Plasma level of hemoglobin (Hb) will be compared in the treatment group and control group

    Time frame: 3 months

  6. Plasma level of C-reactive protein (CRP)

    Plasma level of C-reactive protein (CRP) will be compared in the treatment group and control group

    Time frame: 3 months

07

Study locations

1 of 1 sites recruiting
  • Saad Abul ella fertility Centre
    Khartoum, 11111, Sudan
    Recruiting
08

References and documents

Individual participant data

Plan to share: Undecided — still undecided

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Start is estimated for Sep 2017; primary completion for Sep 2018, 12 months later.

How these figures are worked out, and which studies are left out of them.

Registered
Aug 24, 2017
First posted
Aug 31, 2017
StartEst.
Sep 1, 2017
Primary completionEst.
Sep 1, 2018
CompletionEst.
Sep 1, 2019
Last update
Aug 31, 2017
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Aug 31, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03268733
Lead sponsor
University of Khartoum
Collaborators
Awad, Mohamed Ibrahim, M.D., Duria abdulwahab Elrrayes
Responsible party
Mohammed Hassan Alnazeer (Clinical Pharmacist, University of Khartoum) — Principal investigator
First posted
Aug 31, 2017
Start date
Sep 1, 2017 (estimated)
Primary completion
Sep 1, 2018 (estimated)
Completion
Sep 1, 2019 (estimated)
Last update
Aug 31, 2017

Study contacts

Mohammed Hassan Alnazeer
Contact
mhmd_nazir83@yahoo.com
00249912907268
Mohammed Hassan Alnazeer
study chair · University of Khartoum

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Aug 2017. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Studies of the drug tested here: Folic Acid

Other studies in this condition

Polycystic Ovary Syndrome →

Other studies from this sponsor

University of Khartoum

Start the discussion