ClinicalTrials.gg
CompletedNCT07931625Updated Nov 12, 2026

Myo-Inositol and D-Chiro-Inositol Versus Metformin for Treating Anovulation in Women With Polycystic Ovary Syndrome

An interventional study of Myoinositol and D-Chiro-Inositol in Polycystic Ovarian Syndrome (PCOS), sponsored by Fauji Foundation Hospital. Completed at 1 site in Pakistan. Open to female participants aged 18 Years to 40 Years. Per ClinicalTrials.gov, last updated 2026-11-12.

Sponsored by Fauji Foundation Hospital · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 2 years 2 months after the study started (first participant enrolled Aug 2024, registered Oct 2026).
Updated Nov 12, 2026Newly registeredGo to Updates ↓

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Phase
Not applicable
Study type
Interventional
Enrollment
90
Allocation
Randomized
Ages
18 Years to 40 Years
Sex
Female
01

Where this study stands

Counted across the records on this site · 2026-11-14

Among 40 studies in Polycystic Ovary Syndrome with a site in Pakistan — 7 open to participants now, 10 under way, none of them phase 3. Polycystic Ovary Syndrome · Pakistan.

Enrollment
15th of 39
90 · median 70
Started
2024
with 5 others
No phase
28 of 40
6 open now
Registered
40th of 40
by date
Lead sponsor
1 of 40
Fauji Foundation Hospital

Among the 40 studies in Polycystic Ovary Syndrome with a site in Pakistan, this one is the 15th largest by enrollment of the 39 interventional ones that give a count, is one of 6 that started in 2024, is one of 28 with no phase, and was the 40th registered.

Polycystic Ovary Syndrome

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

Browse Polycystic Ovary Syndrome studies →

Open to participants now

7 of the 40 studies in Polycystic Ovary Syndrome with a site in Pakistan are open now. Recruiting first, the newest first:

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All 7 open studies →

A study can be open while its sites in Pakistan have not opened yet or have stopped. Only those recruiting at a site in Pakistan →

Who these studies take

Of the 119 Polycystic Ovary Syndrome studies recruiting now, 11 (9%) set no upper age limit and 105 (88%) stop at 75 or younger; 23 take children under 18; 41 take healthy volunteers.

This study: 18 Years to 40 Years · female · no healthy volunteers.

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02

Study summary

Polycystic ovary syndrome (PCOS) is a common hormonal disorder in women of reproductive age. It can cause irregular menstrual cycles and difficulty in achieving pregnancy due to anovulation (failure to release an egg from the ovary).

This randomized controlled trial will compare the outcome of combined Myo-inositol and D-chiro-inositol with Metformin among women with anovulatory PCOS.

A total of 90 women aged 18-40 years will be included. Participants will be randomly divided into two groups, with 45 women in each group.

Group A will receive Myo-inositol 2000 mg, D-chiro-inositol 50 mg, and folic acid 200 micrograms twice daily for three months. Group B will receive Metformin 500 mg twice daily for three months.

Both groups will receive dietary advice and instructions to walk and exercise for 30 minutes daily.

The primary outcome will be ovulation after treatment. Ovulation will be assessed by ultrasound examination. The study will compare the proportion of women achieving ovulation in both treatment groups.

The findings will help assess the comparative outcomes of these two treatment approaches in women with anovulatory PCOS.

Read the detailed description

Polycystic ovary syndrome (PCOS) is an endocrine disorder associated with menstrual irregularities, hyperandrogenism, insulin resistance, and anovulation. Anovulation can contribute to infertility and reproductive difficulties.

Myo-inositol and D-chiro-inositol are involved in insulin signalling and ovarian function. Their combined use may improve metabolic and reproductive features in women with PCOS. Metformin is an insulin-sensitizing medication commonly used in women with PCOS.

This study is designed to compare the outcome of combined Myo-inositol and D-chiro-inositol versus Metformin among women with anovulatory PCOS.

The study will be conducted at the Department of Obstetrics and Gynaecology, Fauji Foundation Hospital, Rawalpindi. It will be a randomized controlled trial using non-probability consecutive sampling. A total of 90 women aged 18-40 years will be enrolled and randomly allocated into two groups.

Group A will receive:

  • Myo-inositol 2000 mg twice daily.
  • D-chiro-inositol 50 mg twice daily.
  • Folic acid 200 micrograms twice daily.
  • Dietary advice and instructions for 30 minutes of daily walking and exercise.

Group B will receive:

  • Metformin 500 mg twice daily.
  • Dietary advice and instructions for 30 minutes of daily walking and exercise.

Both treatment regimens will continue for three months.

Women with known diabetes, hypertension, liver disease, renal disease, or a history of smoking will be excluded.

After treatment, ultrasound examination will be performed to assess follicular development. The study will assess ovulation according to the protocol's operational definition, which identifies a mature follicle measuring 17-22 mm on ultrasound.

The primary outcome will be the occurrence of ovulation. The proportion of women achieving this outcome will be compared between the two groups.

Data will be analyzed using SPSS version 26. Quantitative variables will be presented as mean and standard deviation. Qualitative variables will be presented as frequencies and percentages. The Chi-square test will be used to compare ovulation between the groups. A p-value of 0.05 or less will be considered statistically significant.

The findings will provide comparative evidence regarding these treatment approaches in women with anovulatory PCOS.

03

Conditions studied

  • Polycystic Ovarian Syndrome (PCOS)

Keywords

  • PCOS
  • anovulation
  • Myo-inositol
  • folic acid
  • Metformin
  • ovulation
  • D-chiro-inositol
04

Who can participate

Ages eligible
18 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

  • Women aged 18-40 years.
  • Women diagnosed with polycystic ovary syndrome (PCOS).
  • Women with anovulatory menstrual cycles.

Exclusion criteria

Exclusion Criteria:

  • Known diabetic patients.
  • Known hypertensive patients.
  • Patients with known liver disease.
  • Patients with known renal disease.
  • Women with a history of smoking.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
90 participants (actual)

Study arms

  • Experimental
    Group A - Myo-inositol + D-chiro-inositol + folic acid.

    Participants will receive Myo-inositol 2000 mg, D-chiro-inositol 50 mg, and folic acid 200 micrograms twice daily for three months, along with dietary advice and instructions for 30 minutes of daily walking and exercise.

    Dietary Supplement: Myoinositol · Dietary Supplement: D-Chiro-Inositol · Dietary Supplement: Folic Acid

  • Active comparator
    Group B: Metformin

    Participants will receive Metformin 500 mg twice daily for three months, along with dietary advice and instructions for 30 minutes of daily walking and exercise.

    Drug: MetFORMIN

Interventions

  • Dietary supplementMyoinositol

    Myo-inositol 2000 mg administered orally twice daily for 3 months, in combination with D-chiro-inositol 50 mg and folic acid 200 micrograms twice daily.

  • Dietary supplementD-Chiro-Inositol

    D-chiro-inositol 50 mg administered orally twice daily for 3 months, in combination with myo-inositol 2000 mg and folic acid 200 micrograms twice daily

  • Dietary supplementFolic Acid

    Folic acid 200 micrograms administered orally twice daily for three months as part of the combination treatment with myo-inositol and D-chiro-inositol.

  • Metformin 500 mg administered orally twice daily for three months.

06

What researchers measure

Primary outcomes

  1. Proportion of Women Achieving Ovulation

    Ovulation will be assessed by ultrasound examination after treatment. According to the study's operational definition, a mature ovarian follicle measuring 17-22 mm on ultrasound will be considered evidence of ovulation. The proportion of women achieving this outcome will be compared between the two treatment groups.

    Time frame: At the end of three months of treatment

07

Study locations

1 site
  • FaujiFoundation
    Rawalpindi, Punjab Province 59000, Pakistan
08

References and documents

Publications

  • Gul M, Khan H, Rauf B, Bukhari SMS, Ehtesham E, Malik MO, Shah FA, Alanazi FE, Shah M. Comparative efficacy of combined myo-inositol and D-chiro inositol versus metformin across PCOS Phenotypes: enhancing ovarian function, ovulation, and stress response in a prospective clinical trial. Naunyn Schmiedebergs Arch Pharmacol. 2025 Jul;398(7):8761-8772. doi: 10.1007/s00210-025-03813-9. Epub 2025 Jan 23. PubMed 39847053 ↗

Individual participant data

Plan to share: Undecided — currently not decided

09

Timeline

1 registry update since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Aug 2024 to primary completion in Aug 2026, 23 months.

Of 203 non-industry interventional studies with no phase under Polycystic Ovary Syndrome, half reached primary completion within 18 months of starting (the median), counting those still running; a quarter within 7 and three quarters within 37. This study's 23 months is above that.

Counting every sponsor, half of 218 studies reached it within 18 months; a quarter within 7 and three quarters within 37.

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

Registered
Oct 30, 2026
First posted
Nov 12, 2026
StartActual
Aug 10, 2024
Primary completionActual
Aug 9, 2026
CompletionActual
Aug 9, 2026
Last update
Nov 12, 2026
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.
Registered
First appeared on the registry. No changes since
Nov 12, 2026
Show all 1 update
  1. Nov 12, 2026
    First appeared on the registry

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07931625
Lead sponsor
Fauji Foundation Hospital
Responsible party
Tanzil UR-Rehman (Doctor, Fauji Foundation Hospital) — Principal investigator
First posted
Nov 12, 2026
Start date
Aug 10, 2024
Primary completion
Aug 9, 2026
Completion
Aug 9, 2026
Last update
Nov 12, 2026

Study contacts

Ayesha Malik, MBBS
principal investigator · Fauji Foundation Hospital

Oversight

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

Not currently enrolling

This study is completed, as verified in Nov 2026. You cannot join it, but the record below documents what was studied.

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Discussion

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Studies of the drug tested here: Chiro-inositol, (+)-

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