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NCT Number: NCT07462065

Effect Clomiphene vs Clomiphene Along With Pioglitazone on Ovarian Stimulation Rate

Women who meet the study requirements will be enrolled and randomly assigned by a computer system to receive either pioglitazone 30 mg daily or a placebo starting from the second day of their menstrual period for the same duration. All participants will also take clomiphene citrate 150 mg daily from day 3 to day 7 of the menstrual cycle. A transvaginal ultrasound will be performed on day 10 of the menstrual cycle to assess the growth of ovarian follicles, and the number of mature follicles (16-24 mm) will be recorded. If at least one mature follicle measuring 16-24 mm is present and the endometrial thickness is at least 7 mm, an injection of human chorionic gonadotropin (hCG) will be given to trigger ovulation, followed by an intrauterine insemination (IUI) procedure. Participants will be followed until the end of the menstrual cycle, and if the menstrual period is delayed by 5 days, a blood test for β-hCG will be performed to confirm pregnancy. Any side effects during the treatment period, such as swelling, fluid retention, blurred vision, or weight gain, will be recorded.

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Key information

Conditions

Infertility Treatment Pregnancy Rates

Age range

18 year–38 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

Pakistan Atomic Energy Commission Hospital

Islamabad, Federal, 44000, Pakistan

Location status: Recruiting

Location contact

Ayesha Tariq, MBBS

CONTACT

[email protected]

About this study

Patients fulfilling the inclusion criteria will be enrolled and randomized using computer-generated random numbers to receive either pioglitazone 30 mg daily or a placebo starting from the second day of menstruation for a similar duration. All participants will receive clomiphene citrate 150 mg between the third and seventh days of the menstrual cycle. Transvaginal sonography will be performed on the 10th day of the menstrual cycle, and the number of large follicles (16-24 mm) will be recorded. Human chorionic gonadotropin (hCG) will be administered to patients with at least one follicle measuring 16-24 mm and an endometrial thickness of at least 7 mm, followed by intrauterine insemination (IUI). Patients will be followed until the end of the menstrual cycle, and in cases of a 5-day delay in menstruation, a blood sample will be obtained to measure β-hCG for biochemical confirmation of pregnancy. Any adverse effects observed during the treatment period, including edema, fluid retention, blurred vision, or weight gain, will be documented.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Clomiphene Citrate.

Drug

150 mg clomiphene citrate will be administered at third and seventh days of the menstrual cycle

Pioglitazone (PIO) + Clomiphene citrate

Drug

Patients will receive 30 mg pioglitazone daily; from the second day of menstruation along with 150 mg clomiphene citrate will be administered to both groups between the third and seventh days of the menstrual cycle.

Primary outcomes

  1. Ovarian stimulation rate

    Time frame: 10th day of menstrual cycle

    This will be determined by no. of large size follicles (16-24mm in size) recruited following treatment on 10th day of menstrual cycle using transvaginal ultrasound to measure the size and no. of follicles.

Secondary outcomes

  1. Pregnancy rates

    Time frame: 5th day after end of menstrual cycle

    It will be measured in terms of number of patients out of total number treated who conceived. This will be confirmed clinically as well as by measuring serum bHCG levels if patient doesn't not menstruate for more than 5 days following end of her reproductive cycle.

Study contacts

Contact information is provided by the study sponsor or research team.

Kinza Principal Investigator, MBBS

CONTACT

[email protected]

+92-333-3275552

Sponsors and collaborators

Lead sponsor

PAEC General Hospital, Islamabad

Other

Registry information

Official study 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

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Mar 10, 2026
Registry last updated
Mar 10, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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