Clomiphene versus clomiphene plus pioglitazone for improving ovarian stimulation in women with PCOS
Official title: Comparison of Clomiphene Citrate vs Clomiphene Citrate in Combination With Pioglitazone in Terms of Ovarian Stimulation and Pregnancy Rates Among Infertile Women Suffering From Polycystic Ovarian Syndrome
Run by PAEC General Hospital, Islamabad · NCT07462065 · Data updated 2026-11-12
This trial sees if adding pioglitazone to clomiphene helps women with PCOS produce more mature ovarian follicles and increases pregnancy chances.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years to 38 Years |
| Sex | Women only |
| Enrollment | 62 (estimated) |
| Sponsor | PAEC General Hospital, Islamabad Academic / other |
| Locations | 1 site (Islamabad, Federal) |
| Status | Recruiting |
| Started | March 1, 2026 |
| Main results expected | June 1, 2026 |
| Study ends | June 1, 2026 |
| Registry record updated | March 10, 2026 |
| Trial ID | NCT07462065 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are women with PCOS, normal hysterosalpingography, normal partner semen analysis, and ovarian cysts under 20 mm who meet the study's health criteria.
✕Probably not a fit
Women with diabetes or significant cardiovascular, renal, thyroid, or pulmonary disease are excluded and are unlikely to benefit from this protocol.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
Women with PCOS and normal hysterosalpingography and partner semen will be randomly assigned to receive either pioglitazone 30 mg daily or placebo starting on day 2 of the cycle while all participants receive clomiphene citrate 150 mg on days 3–7. A transvaginal ultrasound on day 10 will record the number of mature follicles (16–24 mm) and endometrial thickness, and patients meeting criteria will receive hCG to trigger ovulation followed by intrauterine insemination. Participants are followed through the cycle and a β-hCG blood test is done if menses are delayed by five days to confirm pregnancy, with monitoring for adverse effects such as edema, weight gain, or visual changes. Patients with significant cardiovascular, renal, thyroid, pulmonary disease, or diabetes are excluded.
Why it matters
Potential benefit: If successful, adding pioglitazone could increase the number of mature follicles and improve pregnancy rates for women with PCOS undergoing clomiphene stimulation.
How similar studies have gone: Prior studies of insulin-sensitizing agents like metformin and some data on pioglitazone have shown improved ovulation in PCOS but results and safety for pregnancy outcomes are mixed.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: Normal hysterosalpingography Normal spermogram Suffering from PCOS Ovarian cysts less than 20mm. Exclusion Criteria: History of chronic cardiovascular disease Chronic kidney disease Diabetes Thyroid disease Pulmonary disease
Where it's running
-
Pakistan Atomic Energy Commission Hospital
Islamabad, Federal, Pakistan Recruiting
Study contacts
- Study coordinator: Kinza Principal Investigator, MBBS
- Email: kinza.azharr@gmail.com
- Phone: +92-333-3275552
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.