Actively Recruiting

Phase 4
Age: 18Years - 38Years
FEMALE
Healthy Volunteers
ID07462065

Comparison of Clomiphene Citrate vs Clomiphene Citrate with Pioglitazone in Ovarian Stimulation and Pregnancy Rates Among Women with Polycystic Ovarian Syndrome

Led by PAEC General Hospital, Islamabad · Updated on 2026-03-10

62

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

AI-Summary

What this Trial Is About

This research aims to evaluate the effects of clomiphene citrate alone versus clomiphene citrate combined with pioglitazone on ovarian stimulation and pregnancy rates in women with polycystic ovarian syndrome (PCOS) who are experiencing infertility. It is a phase 4, randomized, double-blind trial enrolling women aged 18 to 38 years with specific inclusion criteria related to fertility and ovarian health. Participants will be randomly assigned by a computer system to receive either 30 mg of pioglitazone daily or a placebo starting on day 2 of their menstrual cycle. All participants will also take 150 mg of clomiphene citrate daily from day 3 to day 7 of the cycle. On day 10, a transvaginal ultrasound will assess ovarian follicles, and if criteria are met, an injection of human chorionic gonadotropin (hCG) will trigger ovulation, followed by intrauterine insemination (IUI). During the study, participants will be monitored until the end of their menstrual cycle. If menstruation is delayed by 5 days, a blood test will check for pregnancy. Side effects such as swelling, fluid retention, blurred vision, or weight gain will be recorded. The primary outcome measured is ovarian stimulation rate on day 10, and secondary outcomes include pregnancy rates evaluated five days after the cycle ends.

CONDITIONS

Brief Title

Effect Clomiphene vs Clomiphene Along With Pioglitazone on Ovarian Stimulation Rate

Who Can Participate

Age: 18Years - 38Years
FEMALE
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Normal hysterosalpingography
  • Normal spermogram
  • Diagnosed with polycystic ovarian syndrome (PCOS)
  • Ovarian cysts smaller than 20 mm
Not Eligible

You will not qualify if you...

  • History of chronic cardiovascular disease
  • Chronic kidney disease
  • Diabetes
  • Thyroid disease
  • Pulmonary disease

AI-Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

Treatment

Duration - One menstrual cycle

Participants receive clomiphene citrate between the third and seventh days of their menstrual cycle. Those in one group also take pioglitazone daily starting from the second day of menstruation. Transvaginal sonography is performed on the 10th day of the cycle to assess ovarian stimulation.

1 visit on the 10th day of the menstrual cycle (in-person)

Follow-up

Duration - Until the end of the menstrual cycle plus up to 5 days

Participants are followed until the end of their menstrual cycle. If menstruation is delayed by 5 days, a blood sample is taken to confirm pregnancy. Adverse effects are monitored during treatment.

1 to 2 visits depending on menstruation timing

Trial Site Locations

Total: 1 location

1

Pakistan Atomic Energy Commission Hospital

Islamabad, Federal, Pakistan, 44000

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Research Team

K

Kinza Principal Investigator, MBBS

How is the study designed?

Study Type

INTERVENTIONAL

Masking

DOUBLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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Published Research Related To This Trial

Combination of pioglitazone and clomiphene citrate versus clomiphene citrate alone for infertile women with the polycystic ovarian syndrome.

Maliheh Amirian, Sedigheh Shariat Moghani, Faezeh Jafarian...

https://pubmed.ncbi.nlm.nih.gov/34404415